Zingiber and Acmella Against Knee Osteoarthritis
キーワード
概要
説明
To evaluate the safety and the efficacy on pain and inflammation of a new food-grade lecithin formulation of standardized extracts of Zingiber officinale and Acmella oleracea.
日付
最終確認済み: | 03/31/2019 |
最初に提出された: | 03/25/2019 |
提出された推定登録数: | 04/04/2019 |
最初の投稿: | 04/08/2019 |
最終更新が送信されました: | 04/04/2019 |
最終更新日: | 04/08/2019 |
実際の研究開始日: | 01/31/2017 |
一次完了予定日: | 12/30/2017 |
研究完了予定日: | 02/14/2018 |
状態または病気
介入/治療
Dietary Supplement: One-group pretest-posttest quasi-experimental design
段階
アームグループ
腕 | 介入/治療 |
---|---|
Other: One-group pretest-posttest quasi-experimental design 50 subjects with moderate knee osteoarthritis were supplied for four weeks with two tablets/day, each containing 350 mg of standardized extracts of Zingiber officinale and Acmella oleracea. | Dietary Supplement: One-group pretest-posttest quasi-experimental design Subjects were supplied for four weeks with two tablets/day and there was the evaluation of pain intensity, by a 30-days Visual Analogue Scale (VAS) and b) the assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and by Tegner Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment, Health-related quality of life, by the ShortForm36, inflammation by C-reactive protein and Erythrocyte Sedimentation Rate, body composition by dual-energy X-ray absorptiometry measured at baseline and 30 days after treatment. |
適格基準
研究の対象となる年齢 | 40 Years に 40 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: - established moderate knee OA (classification 1-3 according to Kellgren and Lawrence system for classification of knee OA) - Lequesne Index of 6-10; 3) Body Mass Index (BMI) between 22 and 30 kg/m2 - aged 40-75 - no drugs for OA, such as nonsteroidal anti-inflammatory drugs (NSAIDs). Exclusion Criteria: - diabetes, metabolic disease, or neoplasia, as well as the patients with disabling diseases that could directly affect muscle weakness (such as neurological diseases, hip fractures, or amputations) |
結果
主な結果の測定
1. Change in generic pain (Visual Analogue Scale) [0-15-30 days]
2. Change in knee pain (WOMAC) [0-15-30 days]
3. Change in knee functionality (TLKS) [0-15-30 days]
二次的な結果の測定
1. Change Health-related quality of life: ShortForm36 [0-30 days]
2. Change in inflammatory blood markers (CRP) (mg/dl) [0-30 days]
3. Change in Total fat mass (Kg), free fat mass (Kg) and visceral adipose tissue (Kg). [0-30 days]
4. Change in inflammatory blood markers (ERS) (mm) [0-30 days]