A randomized, placebo-controlled, double blind study to evaluate the effect and tolerabilityof Withania Somnifera on physical performance, biomarkers of inflammation and musclestatus in healthy volunteers.

I0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male and female, 18 to 30 years
•2. Volunteers with normal health status which will be assessed by below mentioned investigations.
•1) Clinical history and physical examination
•2) Hematological: Hb, CBC within 10% of the normal range detected at screening
•3) Biochemical: Serum SGOT, SGPT & Serum BUN and Serum Creatinine, FBS, S.LDL, S. Cholesterol, S. Triglycerides within 1.5 times upper limit of normal range detected at screening.
•3. Volunteers ready to refrain from unaccustomed strenuous physical activity and follow constant diet pattern at least one week before starting the study & throughout the study duration & those who do not drink & smoke (at least for past six months)
•4. Volunteers with no h/o any lower limb or upper limb injury within past six months or co-morbid condition, underwent surgical procedure wherein exercise is contraindicated.
•5. Volunteers ready to abide by trial procedures and to give a written informed consent.

•1. Volunteers with h/o of allergy or intolerance to herbal drugs or anaphylactic reaction
•2. Volunteers with h/o intake of traditional systems of medicine including drugs with Rasayana properties in the past 4 weeks.
•3. Volunteers with BMI less than 23 or more than 30.
•4. Pregnant and lactating woman.
•5. Volunteers taking anabolic steroids, protein supplements or other nutritional supplements, vitamins, anti oxidants for more than 5 days on contionous basis and use of any recreational drug or a history of drug addiction.
•6. Volunteers with known cardiovascular, musculoskeletal, hepatobiliary, genitourinary, neurological or any psychiatric condition.
•7. Volunteers on any chronic medication ( > 2weeks in the last six months)
•8. Volunteers who have recently joined gymnasium in past one month and are doing active resistance exercises.
•9. Volunteer participating in another investigational drug trial in the previous 30 days.
•10. Volunteers who cannot give valid consent such as mentally retarded or with psychiatric illness.
•11. Volunteers with documented h/o positive screening result for hepatitis B and/or hepatitis C virus and documented h/o HIV or any immune deficient conditions

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