A study to evaluate effiacy and safety of KSM-66 Ashwagandha (Withania somnifera) on improving cardiorespiratory endurance in healthy athletic adults

Phase 3

Completed

Brief Summary: This is a randomized, parallel-group, double-blind, placebo-controlled

study to evaluate the efficacy and safety of KSM-66 ashwagandha on

cardio respiratory endurance in healthy athletic adults. The efficacy will be assessed by using 20M shuttle run test (Vo2 max), Borg scale Test and QOL questionnaires.

Recruitment & Eligibility

Inclusion Criteria

Healthy athletic adults of male and female subjects aged between 20 and 45 years.
Subjects within the BMI range of 18.5 to 24.9 kg/m2 3.
Subjects able to communicate effectively 4.
Subjects willing to provide written informed consent 5.
In the judgment of the Principal Investigator, able to comply with protocol requirements.

Exclusion Criteria

1 Contraindications or Hypersensitivity to ashwagandha and related herbal products.
2 History or presence of any medical condition or disease according to the discretion of the Investigator.
3 History of significant renal or hepatic problems.
4 History of significant asthma, urticaria or other allergic reactions 5 History of severe GI disorders such as mal-absorption syndrome.
6 History of diabetes, coronary artery disease and hypertension with or without complication 7 History of any chronic physical, hormonal or psychiatric illness 8 Morbid Obesity (percent fat 40% 9 Any medical condition where exercise is contraindicated 10 Recent surgery or trauma which incapacitates the subject for exercise.
11 Currently taking any herbal preparations (other formulations containing ashwagandha / ginseng / ginkgo biloba / brahmi etc).
12 Current substance dependence 13 Individuals refusing to use appropriate non-hormonal birth control measures.
14 Subjects participating in any other trial.
15 Female subjects found positive in urine pregnancy test.
16 Female subjects who are under breast feeding.

Primary Outcome Measures

Name	Time	Method
The change in the 20M shuttle run test score from Visit 0 to after	day 0, day 28, day 84
Day 56 (Visit 2) and Day 84 (Visit 3) of treatment.	day 0, day 28, day 84

Secondary Outcome Measures

Name	Time	Method
Safety will be assessed from the number of adverse events	occurred and judging their causal relationship to the study drug.

Locations (1): Hyderabad Spine Clinic
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Hyderabad Spine Clinic
🇮🇳Hyderabad, ANDHRA PRADESH, India
Prof Maj Dr S Bakhtiar Choudhary
Principal investigator
040656470104
sbakhtiar@hotmail.com