WO2016162821A2

WO2016162821A2 - Medicament and nutritional supplement

Info

Publication number: WO2016162821A2
Application number: PCT/IB2016/051978
Authority: WO
Inventors: David MOLEFI; Jan Hendrik Van Der Westhuizen
Original assignee: Molefi David
Priority date: 2015-04-07
Filing date: 2016-04-07
Publication date: 2016-10-13
Also published as: WO2016162821A3; ZA201801218B

Abstract

This invention relates to a medicament. It also relates to a nutritional supplement. More particularly it relates to a medicament and to a nutritional supplement, which are extracts from a plant or a combination of plants. The extract according to the information has been found to be useful in the treatment of AIDS and AIDS related conditions and certain other conditions and to be beneficial as a food or nutritional supplement. The present invention provides for the use of the roots of Burkea africana in the manufacture of a medicament for the treatment of a condition in the group consisting of AIDS and AIDS-related conditions, viral infections, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism in man, or where appropriate in an animal.

Description

MEDICAMENT AND NUTRITIONAL SUPPLEMENT

TECHNICAL FIELD This invention relates to a medicament. It also relates to a nutritional supplement. More particularly it relates to a medicament and to a nutritional supplement, which are extracts from a plant or a combination of plants. The extract according to the information has been found to be useful in the treatment of AIDS and AIDS related conditions and certain other conditions and to be beneficial as a food or nutritional supplement.

BACKGROUND ART

Burkea africana Hook (Fabaceae, Caesalpinioideae) (hereinafter referred to as Burkea africana) is a medium sized tree with relatively long straight branches occurring in the northern provinces of South Africa and in Zimbabwe, Botswana and northern Namibia, where it is primarily utilized as firewood, for making handles for household implements and as construction and fencing timber by indigenous people. It is known by the common names Wild Seringa, Red Syringa and, in Afrikaans, Wilde Sering and Rooi Sering. In Field Guide to the Trees of the Kruger National Park by Piet van Wyk (ISBN 0 86977 221 ) it is said that the plant is of limited medicinal use. Such medicinal use of the plant is apparently so limited that no reference to the plant is found in the book of B-E van Wyk, B van Oudtshoorn and N Gericke entitled Medicinal Plants of South Africa (ISBN 1 875093 09 5). Palgrave in Trees of Southern Africa (ISBN 1 86825 171 3) however discloses that in Zimbabwe the Zezuru people chew the bark of this plant and apply it as a poultice to septic sores. DC Fowler in a paper entitled Traditional Fever remedies: a list of Zambian plants reports that in Upper Volta the leaves of Burkea Africana are used to make a draught to treat fever, and that in Zimbabwe the leaves of the plant are mixed with those of Lippia javanica and boiled, and the steam inhaled as a remedy for fever, fever here being commonly associated with malaria. J Mudekwe in a paper entitled Reconciling Local Subsistence Use and Forest Conservation: Social and Ecological Dynamics of Forest Resource Use in a Protected State Forest makes a passing reference to the use of the roots of Burkea Africana for the treatment of sores, without disclosing how it is so used or what the nature is of the sores being so treated. It would appear that while Burkea Africana has been included in various bioprospecting projects it has not elicited any special attention. Thus SE Atawodi in a paper entitled Antioxidant potential of African medicinal plants in African Journal of Biotechnology Vol 14 Num 2 2005 pp128 -133 lists the stem bark of Burkea africana amongst some 40-odd other plants as having "good" antioxidant potential and as having proanthocyanidins, catechin, epicatechin & fisetinidol as active components without elevating it above the rest of the plants referred to on any basis. Mathesin et al. have reported on a study of the antioxidant and radical scavenging activity of the bark of Burkea Africana in their paper entitled Antioxidants from Burkea Africana, an African Medicinal plant, in Phytotherapy Research Vol 16, Issue 2 pp 148-153. Steenkamp, Fernandes and van Rensburg in their paper Screening of Venda medicinal plants for antifungal activity against Candida albicans, South African Journal of Botany Vol 73 Issue 2 pp 256-258 refers to Burkea Africana amongst a group of 32 plant species but its activity was apparently not found to be such as to earn it a place amongst the species specifically referred to in the abstract of the paper. The same applies in the case of the report of Diallio et al. entitled Screening of Malian medicinal plants for antifungal, larvicidal, molluscicidal, antioxidant and radical scavenging activities in Phytotherapy Research 2001 Aug., 15(5): 401 -6, which reports on the screening of 78 different extracts from 20 medicinal plants from 14 plant families.

Sclerocarya Birrea (Anacardiaceae) is a well known medicinal plant that also occurs in the same geographical area as Burkea africana. It has the common name marula and, in Afrikaans, maroela.

OBJECT OF THE INVENTION

It is an object of the present invention to provide a new and inventive use of a specific part of the Burkea africana plant in the manufacture of a medicament for use in the treatment of a group of ailments not previously recognized as being treatable by means of extractions from that part of this plant, or to be used as a nutritional supplement and to provide for a combination medicine or nutritional supplement comprising an extract from a mixture of Burkea africana and Sclerocarya birrea. SUMMARY OF THE INVENTION

The present invention provides for the use of the roots of Burkea africana in the manufacture of a medicament for the treatment of a condition in the group consisting of AIDS and AIDS- related conditions, viral infections, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism in man, or where appropriate in an animal.

The invention thus also relates to a method for the treatment of a patient suffering from a condition selected from the group consisting of AIDS and AIDS-related conditions, viral infections, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism comprising the step of administering to a patient in need of such treatment a therapeutically beneficial quantity of a medicament manufactured by the use of the root of Burkea africana.

The invention also comprises a medicament for use in the treatment of a condition in the group consisting of AIDS and AIDS-related conditions, viral infections, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism in man, or where appropriate in an animal, which is produced by the use of the root of Burkea africana.

The aforesaid use of the root of Burkea africana according to the invention preferably includes the step of preparing an extract of the root by means of a pharmaceutically acceptable solvent. The solvent may be water, methanol, ethanol, or any other pharmaceutically acceptable solvent. The solvent is preferably one that may safely be administered orally to, or otherwise ingested by, a human or animal.

The present invention also provides for the use of the roots of Burkea africana in the manufacture of a nutritional supplement.

The latter use of the root of Burkea africana according to the invention preferably includes the step of preparing an extract of the root by means of a nutritionally acceptable solvent. The solvent may be water, methanol, ethanol, or any other pharmaceutically acceptable solvent. The solvent is preferably one that may safely be administered orally to, or otherwise ingested by, a human or animal. In both forms of the invention the use comprises the preparation of an aqueous extract of the water soluble active ingredient from the roots of Burkea africana. The extract may be made at elevated temperature, preferably at a temperature of at least 40°C. In the most preferred form of the invention the extract is made by boiling the root of Burkea africana in water. The root is preferably reduced to small pieces, such as by chopping, cutting, shaving, grinding or any other convenient manner in preparation for the extraction step.

The extract of Burkea africana root in water may be prepared by adding any convenient amount of the root to water. Preferably between 1 and 100 gram of Burkea africana root per liter of water is used, and most preferably the extract is made by using between about 20 and about 40 gram of root per liter of water.

The extract may be used as such or it may be concentrated or diluted with any pharmaceutically (or in the second form of the invention, any nutritionally) acceptable solvent to render a preparation containing a medicinally (or nutritionally) beneficial quantity of the extracted active ingredient or ingredients per convenient dose of the preparation. The convenient dose of the preparation may be between 5 and 250 ml of the preparation and is most preferably about 150 ml of the preparation. According to a further aspect of the present invention the use of Burkea africana as identified above further includes the combination of such use with the use of Sclerocarya birrea in a method of manufacture of a medicament for the treatment of a condition in the group consisting of AIDS and AIDS-related conditions, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism in man, or where appropriate in an animal. Preferably the root of Sclerocarya birrea is also used in the method of manufacture of a combination medicament.

Likewise, according to a further aspect of the present invention the use of Burkea africana as a nutritional supplement as identified above further includes the combination of such use with the use of Sclerocarya birrea in a method of manufacture of a nutritional supplement.

In this form of the invention the use of Sclerocarya birrea may also involve the step of preparing an extract of the root by means of a pharmaceutically (or a nutritionally) acceptable solvent. The solvent may again be water, methanol, ethanol, or any other pharmaceutically acceptable solvent. The solvent is also preferably one that may safely be administered orally to, or otherwise ingested by, a human or animal. In one form of this aspect of the invention the use comprises the preparation of an aqueous extract of the water soluble active ingredient from the roots of Sclerocarya birrea. The extract may also be made at elevated temperature, preferably at a temperature of at least 40°C. In the most preferred form of the invention the extract is made by boiling the root of Sclerocarya birrea in water. The root is again preferably reduced to small pieces, such as by chopping, cutting, shaving, grinding or any other convenient manner in preparation for the extraction step.

The extract of Sclerocarya birrea root in water may be prepared by adding any convenient amount of the root to water. Preferably between 1 and 100 gram of Sclerocarya birrea root per liter of water is used, and most preferably the extract is made by using between about 5 and about 20 gram of root per liter of water.

The extract may be used as such or it may be concentrated or diluted with any pharmaceutically acceptable solvent to render a preparation containing a medicinally beneficial quantity of the extracted active ingredient or ingredients per convenient dose of the preparation. The convenient dose of the preparation may be between 5 and 250 ml of the preparation and is most preferably about 150 ml of the preparation. In one form of the invention the extracts of the roots of Burkea africana and of Sclerocarya birrea are separately prepared and the extracts are then combined to produce the combination medicament.

Preferably however the roots of Burkea africana and Sclerocarya birrea are extracted simultaneously. Again the extract of the roots may be produced by means of any pharmaceutically acceptable solvent. The solvent may again be water, methanol, ethanol, or any other pharmaceutically acceptable solvent. The solvent is also preferably one that may safely be administered orally to, or otherwise ingested by, a human or animal. Thus in this form of the invention the use may comprise the simultaneous preparation of an aqueous extract of the water soluble active ingredients from a mixture of the roots of Sclerocarya birrea and Burkea africana. The extract may also be made at elevated temperature, preferably at a temperature of at least 40°C. In an embodiment of the invention the extract is made by boiling a mixture of the roots of Burkea africana and Sclerocarya birrea in water. The simultaneous extraction of Burkea africana root and Sclerocarya birrea root in water may be prepared by adding any convenient amount of the two roots to water. Preferably between 1 and 100 gram of Burkea africana root per liter of water and between 1 and 100 gram of Sclerocarya birrea root per liter of water is used, and most preferably the extract is made by using between about 20 gram and about 40 gram of Burkea africana root per liter of water and between about 5 and about 20 gram of root per liter of water.

Again the extract may be used as such or it may be concentrated or diluted with any pharmaceutically acceptable solvent to render a preparation containing a medicinally beneficial quantity of the extracted active ingredient or ingredients per convenient dose of the preparation. The convenient dose of the preparation may be between 5 and 250 ml of the preparation and is most preferably about 150 ml of the preparation.

Alternatively the use according to the present invention may comprise the making of separate extracts from Sclerocarya birrea and Burkea africana followed by the mixing of the two extracts to produce the medicament of the invention.

These and other aspects of the present invention will now be described in more detail herein and below.

BRIEF DESCRIPTION OF THE FIGURES

The invention will now be described in more detail, by way of example only, with reference to the accompanying figures in which:

Figure 1 : Depicts a bar graph obtained from the results of the inhibition of cytopathic effect assay according to Experiment 2; and

Figure 2: Shows a line graph obtained from the results of the in vitro anticancer assay according to Experiment 5.

The foregoing and other objects and features and advantages of the present invention will become more apparent from the following description of certain embodiments of the present invention by way of the following non-limiting examples.

DESCRIPTION OF THE INVENTION

The invention will now be described with reference to the following non-limiting experimental examples.

Preparation of composition A according to the invention (also called mokaulengwe mixture)

350g of finely chopped Burkea africana root was mixed with 100g of finely chopped Sclerocarya birrea root. The mixture was added to 1 2 litres of water. The resultant mixture was heated to boiling point and boiled for 30 minutes. The boiled mixture was strained to remove solid material therefrom and the resultant liquid, which had a thin syrup-like consistency and was reddish brown in colour was allowed to cool to ambient temperature, bottled and sealed. This product is referred to hereinafter as composition A. Preparation of composition B according to the invention

350g of finely chopped Burkea africana root was added to 12 liters of water. The resultant mixture was heated to boiling point and boiled for 30 minutes. The boiled mixture was strained to remove solid material therefrom and the resultant liquid, which had a thin syruplike consistency and reddish brown in colour was allowed to cool to ambient temperature, bottled and sealed. This product is referred to hereinafter as composition B.

Experiment 1 : Antiviral egg assay

The antiviral activity of the present invention was tested using an egg assay. Here, eggs were inoculated with New Castle virus, with any treatments being applied on the same day. Viability was measured by comparing the number of dead eggs on a given day against the number of live eggs. Eggs dying on day 1 were held to be due to either toxicity of the medicament or inoculation stress, as the viral particles would not have had time to propagate at this point.

The positive control for the experiment consisted of adding 100 μΙ of La Sota NDV vaccine which had been frozen to eggs which contained viruses. The negative control consisted of eggs which had been inoculated with the virus but received no further treatment. Each treatment sample was further tested using control (no virus) and virus-innoculated eggs to determine the relative effects of cytotoxicity and viral inhibition of the medicament, respectively. The results of the experiment are summarised in Table 1 below. Here it should be noted that sample 1 consisted of a dilute extract of composition A, as described herein above. Sample 2 consisted of a concentrated extract of composition A, as described herein above.

Table 1 : Viral inhibition

Viability is measured in number of dead eggs/number of live eggs per day Given the above, it was concluded that the virus was alive and could kill the eggs as seen from the virus controls. All virus infected eggs without further treatment were dead by Day 6.

Sample 1 : inoculated with 100 μΙ. All control eggs (no virus) were alive. All eggs inoculated with virus were dead - no antiviral activity can be seen at this concentration

Sample 2: inoculated with 100 μΙ. Only 1 egg survived in the control eggs (no virus) which could indicate toxicity. Two eggs were still alive in the eggs inoculated with virus. This could indicate antiviral activity.

Sample 1 : inoculated with 200 μΙ. One of the control (no virus) eggs died. Four eggs were still alive at the end of the experiment. Two eggs were still alive in the eggs inoculated with virus. This could indicate antiviral activity. Sample 2: inoculated with 200 μΙ. Only 2 eggs survived in the control eggs (no virus) which could indicate toxicity. All of the eggs were dead on day 7. However, on day 6 four eggs were still alive while all of the virus control eggs were dead - This could indicate inhibition of the virus. Sample 1 : inoculated with 300 μΙ. Only 1 egg died in the control egg group (no virus). Two eggs were still alive in the eggs inoculated with virus. This could indicate antiviral activity.

Sample 2: inoculated with 300 μΙ. Only 1 egg survived in the control eggs (no virus) on day 7. This could indicate antiviral activity.

Sample 1 : inoculated with 400 μΙ. Only 1 egg died in the control eggs (no virus). All of the eggs were dead on day 7. However, 2 eggs were still alive on day 6, while all of the control eggs were dead. This could indicate some antiviral activity. Sample 2: inoculated with 400 μΙ. All of the eggs were dead on day 6 in the control eggs (no virus) which could indicate toxicity. All of the virus infected eggs were dead on day 7. However, 2 eggs were still alive on day 6, while all of the control eggs were dead. This could indicate some antiviral activity. Accordingly, there is clear indication of some anti-viral activity in this experiment. Experiment 2: Inhibition of Cytopathic Effect Assay

The present invention was tested against HIV using a Cytopathic Effect Assay. Here, a sample of composition A or B, or a fraction thereof (10 μΙ maximum volume) was added to wells of a 384-well assay plate followed by the addition of 20 μΙ MT-2 T-cells at a density of 1 x 106 cells/ ml_. Compounds were diluted in maintenance media. The cells were infected with an appropriate amount of HIV NIB virus that will induce≥80% cytopathic effect in 4 days post infection. Lamivudine (3TC) was used as a positive control. Viral cytopathicity was quantified using the MTS cell proliferation kit supplied by Promega.

The results of the experiment are summarised in Figure 1 and Figure 2. Here is should be noted that compounds A2D (25 μg/ml final) and AW742 (6.25 μg/ml final) were retested with the positive control 3TC (seven replicates of each). The virus alone killed 85% of the cells (15% cell viability) which, together with uninfected cells (100% cell viability), was used to normalize the data.

Experiment 3: Schmidtke assay

An antiviral and cytotoxicity assay was performed using the present invention, according to the process developed by Schmidtke et al. (Schmidtke et al A rapid assay for evaluation of antiviral activity against coxsackie virus B3, influenza virus A, and herpes simplexvirus type 1; Journal of Virological Methods (2001 ) 95 pg 133-143). Here, antiviral activity was tested against three viral strains (Influenza, Coxsackievirus and Rhinovirus) using two cell lines (HeLa and MDCK). The results are summarized in Tables 2 and 3 below. Samples A1 D, A1 M, A2D, A2M, B1 D, B1 M, B2D and B2M represent concentrated and dilute mixtures obtained using compositions A or B, or fractions thereof as described herein above, as well as fractions thereof.

Table 2: Antiviral assay (Schmidtke assay)

Table 3: Cytotoxicity assay (Schmidtke assay)

i <90% Survival

Given the above, it can be concluded that both composition A and B demonstrate significant antiviral activity at low concentrations, while also demonstrating significant in vitro cell cytotoxicity only at concentrations higher than those required for effective inhibition.

Experiment 4: In vitro HIV inhibition and cytotoxicity assay

In vitro HIV and cytotoxicity assays were performed using the present invention, as described herein above, by MINTEK. Here, the experiments were carried out on the human MT4 and T-lymphoid cell lines, with 4 replicates being used for the HIV assay and 6 replicates for the cytotoxicity assay. The control compounds for the HIV and the cytotoxicity assay were Raltegravir (100 nM) and Auranofin, respectively. Cell viability was measured by absorbance. A negative cell-free control (empty plate) and positive cell control (no HIV) was used for the HIV assay, with a negative Auranofin control and positive cell control (no other compounds) being used for the cytotoxitiy assay.

As with Experiment 2 above; samples A1 D, A1 M, A2D, A2M, B1 D, B1 M, B2D and B2M represent concentrated and dilute mixtures obtained using compositions A and B, as described herein above, as well as fractions thereof. The results of the assays are summarized in Tables 4 and 5 below.

Table 4: HIV inhibition assay

Table 5: Cytotoxicity assay

From the above, it is clear that the medicament described herein above possesses significant inhibitory properties against HIV in vitro. Further, it is clear that these properties may be obtained even at concentrations where cytotoxicity is minimized.

Experiment 5: In vitro anticancer assay

In vitro anticancer assays for the present invention were performed by the CSIR (Council for Scientific and Industrial Research, South Africa). Here, the growth inhibitory effects of the compounds were tested in the 3-cell line panel consisting of TK10 (renal), UACC62 (melanoma) and MCF7 (breast) cancer cells by Sulforhodamine B (SRB) assay. The SRB assay was developed by Skehan and colleagues to measure drug-induced cytotoxicity and cell proliferation. Its principle is based on the ability of the protein dye sulforhodamine B (Acid Red 52) to bind electrostatically in a pH-dependent manner to protein basic amino acid residues of trichloroacetic acid-fixed cells. Under mild acidic conditions it binds to the fixed cellular protein, while under mild basic conditions it can be extracted from cells and solubilized for measurement. The SRB Assay is performed at CSIR in accordance with the protocol of the Drug Evaluation Branch, NCI, and the assay has been adopted for this screen.

The human cell lines TK10, UACC62 and MCF7 were obtained from NCI in the framework a collaborative research program between CSIR and NCI. Cell lines was routinely maintained as a monolayer cell culture at 37^eC, 5% C0₂, 95% air and 100% relative humidity in RPMI containing 5% fetal bovine serum, 2 mM L-glutamine and 50μg/ml gentamicin.

During the experiment, the cells (3-19 passages) were inoculated in 96-well microtiter plates at plating densities of 7-10 000 cells/well and were incubated for 24 hours. After 24 hours the cells were treated with the Compositions A or B, or fractions thereof, which were previously dissolved in DMSO and diluted in medium to produce 5 concentrations. Cells without drug addition served as a control. The blank contained complete medium without cells. Parthenolide was used as a standard.

The plates were incubated for 48 hours after addition of the compounds. Viable cells were fixed to the bottom of each well with cold 50% trichloroacetic acid, washed, dried and dyed by SRB. Unbound dye was removed and protein-bound dye was extracted with 10mM Tris base for optical density determination at the wavelength 540 nm using a multiwell spectrophotometer.

Data analysis was performed using GraphPad Prism software, with 50% of cell growth inhibition (IC50) as determined by non-linear regression. The assay conditions were as follows:

Samples screened: 13

Test sample concentration: 100 - 0.01 μg/m\ (5 x 10-fold serial dilutions) Reference standard: Parthenolide (100 - 0.01 μς/ιηΙ (5 x 10-fold dilutions)

Assay prerequisites: * Z' factor > 0.5

The results of the assay are summarized in Table 6 below.

Table 6: Anticancer assay results

Given the above, it can be seen that sample AB demonstrated significant inhibitory effect of UAAC cell lines at low concentrations (Figure 2), with other samples demonstrating weaker inhibitory effects. Case studies: HIV positive patients

Several uncontrolled case studies on patients who have been diagnosed as having AIDS were performed by instructing the patents to take 150 ml of either composition A or composition B as described above three times daily. The results are summarized in Table 7 below, in which the treatment applied is referred to as A or B signifying that the patent was given either composition A or composition B as described above.

Table 7: Results of Case Studies

Patient A/ Symptoms before CD-4 count Treatment CD-4 count Symptoms after treatment B treatment before duration after treatment

(days)

treatment

Y A Tiredness, swollen 385 4 616 Feeling much better, full of glands behind ears, rash energy, eating well, no pain, in face, mouth sores, swelling in glands subsiding, great difficulty rash healed, mouth sores swallowing, generalized recovered. body pain

L A Dizziness, tiredness 400 8 485 Feeling much better

0 A Tiredness, itching rash 350 4 N/A No fatigue, rash

in all joints which disappeared, pain subsided, cracked, heavy sweating itching stopped, sweating caused pain in cracked pattern back to normal, sores. appetite improved.

J A Swollen feet, 24 4 56 Feeling much better, pain generalised pain, had to subsided, swelling down stop working considerably.

F A Tiredness, sleeping all 26 3 N/A Great improvement in

the time, depressed, energy level, no longer loss of energy and depressed, working again appetite c A Pain all over body, loss N/A 4 N/A No pain, full of energy, of appetite, fatigue, appetite restored, swelling in swollen glands behind glands and feet subsided. the ears, swollen feet,

walking with difficulty

s B Tiredness, swollen and N/A 2 N/A Improved energy level, painful legs swelling subsiding and no longer painful

Case studies: Other conditions

Patients suffering from various other conditions were given the medication of Composition A or Composition B at the same dosage as described above. The results of these treatments are summarized in Table 8 below.

Table 8: Treatment of other diseases

PATIENT A/B Diagnosis / Condition / Symptoms Treatment Results

Duration

(days)

M A Cancer. Large growth on neck surgically 4 Cancer not spreading any more. Growth in removed, but told that cancer had spread to neck subsiding and becoming softer, the lungs and growth in neck resumed

B A Suffering from asthma for 20 years. Chesty 14 Had no flu and much less coughing in the cough. Usually very sick from autumn to autumn and early winter since taking spring. composition A.

MM A Suffered from painfully hard breast for three 4 Pain subsided and breast back to normal years

AN A Coughing, rash in the face and itchy sores 7 Coughing subsided, rash disappeared, in mouth for three years and sores in mouth healed

X B Female, about 41 years old suffering from 3 Able to walk freely

rheumatism for 9 years. Could not bend her

knees herself and walked with great

difficulty Whilst only certain embodiments or examples of the instant invention have been shown in the above description, it will be readily understood by a person skilled in the art that other modifications and/or variations of the invention are possible. Such modifications and/or variations are therefore to be considered as following within the spirit and scope of the present invention as defined herein.

Claims

Use of the roots of Burkea africana in the manufacture of a medicament for the treatment of a condition in the group consisting of AIDS and AIDS-related conditions, viral infections, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism in man, or where appropriate in an animal.

A method for the treatment of a patient suffering from a condition selected from the group consisting of AIDS and AIDS-related conditions, viral infections, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism comprising the step of administering to a patient in need of such treatment a therapeutically beneficial quantity of a medicament manufactured by the use of the root of Burkea africana.

A medicament for use in the treatment of a condition in the group consisting of AIDS and AIDS-related conditions, viral infections, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism in man, or where appropriate in an animal, which is produced by the use of the root of Burkea africana.

The use of the root of Burkea Africana in accordance with any one of claims 1 , 2 or 3, wherein the use of said root includes the step of preparing an extract of the root by means of a pharmaceutically acceptable solvent.

The use according to claim 4, wherein the solvent is water, methanol, ethanol, or any other pharmaceutically acceptable solvent.

The use according to claim 4, wherein the roots of Burkea africana are used in the manufacture of a nutritional supplement.

The use according to claim 6, including the step of preparing an extract of the root by means of a nutritionally acceptable solvent.

8. The use according to claim 7, wherein the solvent is water, methanol, ethanol, or any other pharmaceutically acceptable solvent.

9. The use of the root of Burkea africana in accordance with any one of the preceding claims, wherein a preparation of an aqueous extract of the water soluble active ingredient is prepared from the roots of Burkea africana. 10. The use according to claim 9, wherein the extract is made at elevated temperature of at least 40°C.

1 1 . The use according to claim 9 or 10, wherein between 1 and 100 gram of Burkea africana root per liter of water is used.

12. Use of Burkea africana in combination with the use of Sclerocarya birrea in a method of manufacture of a medicament for the treatment of a condition in the group consisting of AIDS and AIDS-related conditions, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism in man, or where appropriate in an animal.

13. The use according to claim 12, wherein the root of Sclerocarya birrea is used in the method of manufacture of the combination medicament. 14. Use of Burkea africana in combination with the use of Sclerocarya birrea in a method of manufacture of a nutritional supplement for the treatment of a condition in the group consisting of AIDS and AIDS-related conditions, cancer, asthma, coughing, pain, impaired appetite, fatigue, inflammation, mouth sores, rashes and rheumatism in man, or where appropriate in an animal.

15. The use according to any one of claims 12, 13 or 14, wherein the use of Sclerocarya birrea involves the step of preparing an extract of the root by means of a pharmaceutically (or a nutritionally) acceptable solvent. 16. The use according to claim 15, wherein the solvent is water, methanol, ethanol, or any other pharmaceutically or nutritionally acceptable solvent.

17. The use according to claim 16, wherein a preparation of an aqueous extract of the water soluble active ingredient is prepared from the roots of Sclerocarya birrea.

18. The use according to claim 17, wherein the extract is made at elevated temperature of at least 40°C.

19. The use according to claim 17 or 18, wherein between 1 and 100 gram of Sclerocarya birrea root per liter of water is used.

20. The use according to any one of claims 12 to 19, wherein the extracts of the roots of Burkea africana and of Sclerocarya birrea are separately prepared and the extracts are then combined to produce the combination medicament.

21 . The use according to any one of claims 12 to 19, wherein the roots of Burkea africana and Sclerocarya birrea are extracted simultaneously.

22. The use according to claim 21 , wherein the extract is made at elevated temperature of at least 40°C.

23. The use according to claim 22, wherein the simultaneous extraction of Burkea africana root and Sclerocarya birrea root in water is prepared by adding between 1 and 100 gram of Burkea africana root per liter of water and between 1 and 100 gram of Sclerocarya birrea root per liter of water.

24. The use according to any one of claims 1 , 12 and 14, substantially as herein described and exemplified and/or described with reference to the accompanying figures.

25. The method according to claim 2, substantially as herein described and exemplified and/or described with reference to the accompanying figures. 26. The medicament according to claim 3, substantially as herein described and exemplified and/or described with reference to the accompanying figures.