CTRI/2020/03/023877已完成不适用
A prospective Double Blind, Randomized, Multi-Center, Parallel Group,Two Arm, Placebo-Controlled trial to evaluate the efficacy and safety of TurmXtra 60N (Water Dispersible Turmeric Extract) Capsule in healthy adults having Chronic Knee Joint Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- 1.Change in Pain Visual Analogue Scale (VAS)
研究概览
简要总结
Total 106 healthy, adult human subjects will be enrolled in the study. They will be divided in to two arms. i.e Active and placebo arm and followed up for 3 months. The Primary objective of the study is to evaluate the efficacy and safety of turmeric Extract capsules in chronic knee joint pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects aged between 18-60 years with BMI 18 to 30 kg/m2 and with chronic knee joint pain (at least past 2 months).
- •2.Subjects having moderate pain i.e. visual analogue score of 4 or greater in the knee joint.
- •3.Subjects willing to use ongoing analgesic drugs and/or anti inflammatory drug only as rescue medication until study completion.
- •4.Subject provides written informed consent and comes for regular follow up.
排除标准
- •1.Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
- •2.Post-menopausal female subjects 3.Subjects who are suffering from arthritis of the knee as diagnosed over X-ray 4.Subjects who have taken more than two analgesic drugs and/or anti-inflammatory for more than three months 5.Subjects who have a history of surgery or trauma affecting the knee.
- •6.Impaired renal function; eGFR<60mls/min/1.73m
- •7.Impaired liver enzymes 8.Presence or history of any chronic illness including but not limited to psychiatric, cardiovascular, pulmonary, neurological, hepatic, renal, metabolic, and ophthalmologic including HIV and AIDS taking regular pharmacological agents.
- •9.History of drug dependence or any severe co-morbid medical conditions.
- •10.High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine/Caffeine dependence.
- •11.Subjects on multivitamins/herbal supplements/ any other wellness product 12.Subject who has participated in a clinical study within the last 30 days prior to entering this study.
- •13.Subject with hypersensitivity to any of the ingredients of the study products.
结局指标
主要结局
1.Change in Pain Visual Analogue Scale (VAS)
时间窗: Day 1, Day 45 and Day 90
次要结局
- 1.Improvement in 9-step Stair Climb Test(2. Improvement in 80 meter fast paced walk test)
研究者
研究点 (3)
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