CTRI/2021/12/038892已完成未知
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
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and female subjects 18 ââ?¬â?? 35 years of age with a Body Mass Index (BMI) of 18 to 30 kg/m2.
- •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.
- •5.History / Presence of frequent use of OTC NSAIDS or / and analgesic agents.
- •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.
研究者
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