JP2018505908A - 加齢男性における心理的な、肉体の、および性的な状態を向上させるコロハ抽出物の使用 - Google Patents
加齢男性における心理的な、肉体の、および性的な状態を向上させるコロハ抽出物の使用 Download PDFInfo
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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Abstract
Description
その他の点では健康な加齢男性における男性更年期の症状および血清テストステロンレベルに対する、コロハを含む経口投薬薬用植物製剤の効能についての二重盲検無作為化プラセボコントロール研究を行った。
40〜75歳の120人の健康な男性対象をCRO対象データベースおよび公共の媒体を通して採用した。総合的なスクリーニングは、ライフスタイルについての質問、現在の薬物治療、病歴、および基本的な理学的検査を含む最初の医学的評価の後に実行した。対象を下記の基準に対してスクリーニングした。
45〜75歳の男性;
その他の点では健康;
対象からの書面のインフォームドコンセント。
サンプルサイズは、AMS合計スコアに基づいて計算し、治療群当たり最低48人を必要とすることが分かり、結果的に、脱落者を考慮に入れるために、サンプル群当たり60人のサンプルサイズを研究に採用した。
一旦治験に登録されたら、参加者は、プラセボ比較群(n=60)または積極的介入群(n=60)のいずれかに無作為に分配した。無作為化は、Random Allocation Software、version 1.0、May 2004を使用し、調査者の知らないところで実行した。
調査者には無作為化について知らせず、そのため、どの対象が積極的な治療アームに分配されたか知らなかった。治験製剤および比較製剤を機能および外観が同様のTPC中に密封した。
主要アウトカムエンドポイント(ベースライン、6、12週のAMSアンケートの回答)は、6週目および12週目の統計的な差異について独立標本Mann−Whitney U検定を使用して分析した。DISF−SRは、t−検定によって群内の(ベースラインからの変化)および群間の統計的な差異について判断した。
目的:AMS QOLアンケートを使用して加齢男性におけるリビドーを含む男性更年期の症状に対するコロハ種子抽出物の有効性を判断する。
目的:DISF−Self Report(「DISF−SR」)アンケートを使用して加齢男性におけるリビドーを含む男性更年期の症状に対するコロハ種子抽出物の有効性を判断する。下記の表2を参照されたい。
目的:テストステロンの血清ホルモンレベルに対する加齢男性におけるリビドーを含む男性更年期の症状に対するコロハ抽出物の有効性を判断する。下記の表3を参照されたい。
Claims (11)
- 加齢男性ヒト対象における心理的な、肉体の、および性的な状態を向上させるための方法であって、その必要がある加齢男性ヒト対象に、コロハもしくはコロハ種子またはコロハもしくはコロハ種子の抽出物を投与するステップを含む方法。
- 加齢男性ヒト対象において、男性更年期の症状の重症度を低下させるための、性機能を改善するための、性ホルモンのさらなる減少を予防するための、および/または性ホルモンレベルを改善するための方法であって、その必要がある加齢男性ヒト対象に、コロハもしくはコロハ種子またはコロハもしくはコロハ種子の抽出物を投与するステップを含む方法。
- 前記心理的な状態が、うつ、気分変動、神経過敏、不安、過敏性、集中力不足、および記憶力不足からなる群から選択される1つまたは複数の状態を含む、請求項1に記載の方法。
- 前記肉体の状態が、疲労性、ほてり、発赤、発汗、体脂肪蓄積、体力の低下、骨の病気、および関節の病気からなる群から選択される1つまたは複数の状態を含む、請求項1に記載の方法。
- 前記性的な状態が、リビドーの低下、勃起障害、射精の力の減少、および射精の量の減少からなる群から選択される1つまたは複数の状態を含む、請求項1に記載の方法。
- 前記性機能が、性的認知、性的興奮、性経験、オルガスム、および性的交渉からなる群から選択される1つまたは複数の機能を含む、請求項2に記載の方法。
- 前記性ホルモンが、1つまたは複数のテストステロンおよび遊離テストステロンを含む、請求項2に記載の方法。
- 前記コロハもしくはコロハ種子または前記コロハもしくはコロハ種子の前記抽出物が、固体経口製剤、液体経口製剤、非経口製剤、植物産物(phytoceutical)製剤、栄養補強食品製剤、および食料品またはその任意の有用な組み合わせを含む群から選択される投薬形態に製剤される、請求項1に記載の方法。
- 前記コロハもしくはコロハ種子または前記コロハもしくはコロハ種子の前記抽出物が、固体経口製剤、液体経口製剤、非経口製剤、植物産物製剤、栄養補強食品製剤、および食料品またはその任意の有用な組み合わせを含む群から選択される投薬形態に製剤される、請求項2に記載の方法。
- 前記コロハもしくはコロハ種子または前記コロハもしくはコロハ種子の抽出物が、1日当たり約300mg〜約1000mgの量で投与される、請求項1に記載の方法。
- 前記コロハもしくはコロハ種子または前記コロハもしくはコロハ種子の抽出物が、1日当たり約300mg〜約1000mgの量で投与される、請求項2に記載の方法。
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CN101496828A (zh) * | 2009-02-27 | 2009-08-05 | 湖南今汉生物医药技术有限公司 | 葫芦巴总皂苷提取物的用途 |
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CA2206157C (en) | 1997-05-26 | 2000-06-13 | Cheng, Peter | Method of extraction of commercially valuable fractions of fenugreek |
US20080199517A1 (en) * | 2007-02-19 | 2008-08-21 | Indus Biotech Private Ltd | Composition and a process thereof |
WO2009153800A1 (en) * | 2008-06-17 | 2009-12-23 | Pawan Kumar Goel | A novel process for extraction of furostanolic saponins from fenugreek seeds |
AU2013355181B2 (en) * | 2012-12-05 | 2018-08-09 | Ge Nutrients, Inc. | Use of fenugreek extract to enhance female libido |
US10111895B2 (en) * | 2013-03-15 | 2018-10-30 | Suzanne J. Paxton-Pierson | Androgen effectors |
IN2013DE03119A (ja) * | 2013-10-21 | 2015-04-24 | Tanvir Ali Dr Syed | |
KR101579845B1 (ko) * | 2014-06-30 | 2015-12-23 | 이경수 | 남성호르몬 증가, 지구력 및 근력 증가, 체지방 및 혈중지질 감소, 정자수 및 정자운동성 증가를 통해 남성갱년기 증상인 무기력증과 활력저하, 근력저하, 체지방량 증가, 피로감 및 스트레스 증가를 개선하고 예방 및 치료하는 호로파 또는 호로파를 함유하는 복합조성물 |
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Patent Citations (1)
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CN101496828A (zh) * | 2009-02-27 | 2009-08-05 | 湖南今汉生物医药技术有限公司 | 葫芦巴总皂苷提取物的用途 |
Non-Patent Citations (6)
Title |
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BETTER NUTRITION MAGAZINE-SUPPLEMENT, JPN6019044560, February 2014 (2014-02-01), pages 1 - 5, ISSN: 0004535267 * |
BIOMEDCINE & AGING PATHOLOGY, vol. 2, JPN6019044563, 2012, pages 121 - 125, ISSN: 0004535269 * |
INTERNATIONAL JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES, vol. 3, no. 2, JPN6019044565, 2011, pages 96 - 102, ISSN: 0004535271 * |
INTERNATIONAL JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES, vol. 4, no. 4, JPN6019044567, 2012, pages 136 - 143, ISSN: 0004535270 * |
J.NUTR.SCI.VITAMINOL, vol. 52, JPN6019044566, 2006, pages 287 - 292, ISSN: 0004535272 * |
PHYTOTHERAPY RESEARCH, vol. 25, JPN6019044562, 2011, pages 1294 - 1300, ISSN: 0004535268 * |
Also Published As
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EP3258949A4 (en) | 2018-07-25 |
CN107427544A (zh) | 2017-12-01 |
NZ735025A (en) | 2023-05-26 |
ZA201706283B (en) | 2021-03-31 |
SG11201706717TA (en) | 2017-09-28 |
EP3258949A1 (en) | 2017-12-27 |
MY198811A (en) | 2023-09-29 |
AU2016219927A1 (en) | 2017-09-07 |
WO2016134174A1 (en) | 2016-08-25 |
BR112017017687A2 (pt) | 2018-04-10 |
SG10202108859YA (en) | 2021-09-29 |
CA2977059C (en) | 2022-08-30 |
PH12017501504A1 (en) | 2018-02-05 |
US10576118B2 (en) | 2020-03-03 |
CA2977059A1 (en) | 2016-08-25 |
US20160243179A1 (en) | 2016-08-25 |
KR20170118787A (ko) | 2017-10-25 |
AU2016219927B2 (en) | 2021-01-28 |
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