CTRI/2021/12/038892已完成不适用
A Randomized, Double-Blind, Placebo-Controlled Trial to evaluate the efficacy and safety of TurmXtra 60N in Delayed Onset Muscle Soreness in healthy recreationally active subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Pain Visual Analogue Scale (VAS) [100 mm] score from baseline to end of the treatment.
研究概览
简要总结
Total 30 healthy recreationally active subjects will be enrolled in the study. They will be divided into two arms. i.e, active and placebo arm and followed up for 33 days. The primary objective of the study will be to evaluate the efficacy of turmeric extract (TurmXtra 60N) in recreationally active individuals.
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 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects 18 – 35 years of age with a Body Mass Index (BMI) of 18 to 30 kg/m
- •2.Healthy, moderately active [regular aerobic exercise for at least 150 min per week for past 3 months], non-smoking subjects with no known musculoskeletal pathology.
- •3.Subjects who have been vaccinated with COVID 19 (Two doses) vaccine.
- •4.Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •5.Results of screening tests within normal range or considered not clinically significant by the Principal Investigator.
- •6.Willing to sign the informed consent and comply with study procedure.
- •7.willing to abstain from use of analgesics / NSAIDs during entire treatment period.
排除标准
- •1.Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •2.Subjects with Covid-19 symptoms.
- •3.Subject has known allergy to any compound present in the study product.
- •4.Subjects regularly involved in strength training.
- •6.High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc) /Nicotine/Caffeine dependence.
- •7.History / presence of psychosis, major depressive disorder or other clinically significant psychiatric disorder.
- •8.Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit.
- •9.History of surgery or trauma affecting the knee.
- •10.History / presence of any neurological or muscular disorders that may affect muscle strength.
- •11.History / presence of any chronic illness including but not limited to psychiatric, cardiovascular, pulmonary, neurological, gastrointestinal, hepatic, renal, metabolic, and ophthalmologic disorders; presence of HIV and AIDS; taking regular prescription pharmacological agents.
- •12.Subjects on multivitamins/herbal and/or turmeric supplements/ any other wellness product.
结局指标
主要结局
Change in Pain Visual Analogue Scale (VAS) [100 mm] score from baseline to end of the treatment.
时间窗: Time Points: Day 29 (baseline, immediately post work out and 12 hours post work out), Day 30 (24 h post work out), Day 31 (48 h post work out), Day 32 (72 h post work out) & Day 33 (96 h post work out)treatment.
次要结局
- 1.Delayed-onset muscle soreness (DOMS) score from baseline to end of the treatment(2.Serum creatine kinase (CK) and LDH from baseline to end of the treatment)
研究者
研究点 (1)
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