CTRI/2024/09/073960RecruitingUnknown
Efficacy and Safety of Ashwagandha (Withania Somnifera) Root Extract on Muscle Strength and Endurance In Healthy Athletes: A Prospective, Randomized, Double-BUnd, Placebo-Controlled Study
Ixoreal Biomed Private Limited1 site in 1 country120 target enrollmentStarted: September 25, 2024Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- To evaluate the effects of KSM-66 Ashwagandha formulations on muscle recovery (Delayed-Onset Muscle Soreness (DOMS)) using 0-10 Visual Analog Scale (VAS).
Study Overview
Brief Summary
- All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study
- Subjects will be informed about the purpose of the study and signed informed consent will be taken.
- Blood sampling for efficacy and safety parameters will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 3 (week 8).
- All subjects will be followed-up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4- Telephonic) ± 4 days, and visit 3 (week 8) ± 4 days.
- The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Male and female subjects with age from 18 to 45 years who are healthy athletes
- •Ability to understand the risks and benefits of the protocol
- •Subject with a history of gymnasium visits since the last three months of screening
- •Subject willing to follow the same exercise and diet regime for the study period as prescribed by the study protocol
- •Subject who has given written informed consent to participate in the study and understand the nature of the study
- •Able to read and write in English or any other vernacular language
- •No plan to commence new treatments over the study period.
- •Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Exclusion Criteria
- •1.Participants taking any form of herbal extract in the last 3 months before study entry.
- •2.Any history of drug abuse, smoking 10+ cigarettes a day or consuming more than 14 grams of alcohol daily, 3.Subjects planning to participate in any Sports event during the study period 4.Weight loss of greater than 5kg in the past 3 months 5.History of any orthopedic injury or surgery in the past 6 months 6.Subject diagnosed with heart disease, diabetes, stroke, or other neurological disorders or depression 7.Subject with significant medication use (blood pressure, beta-blockers, inhaled beta-agonists, hormonal contraceptives, corticosteroid use within the prior three months, psychotropic medication use within the prior eight weeks) 8.Subjects with a history of any prohibited drug use 9.Participants with evidence of uncooperative attitude, including poor compliance.
- •10.Participants with inability to attend follow-up visit 11.Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
- •12.Patients with known hypersensitivity to Ashwagandha.
- •13.Patients who had participated in other clinical trials during the previous 3 months.
- •14.Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
Outcomes
Primary Outcomes
To evaluate the effects of KSM-66 Ashwagandha formulations on muscle recovery (Delayed-Onset Muscle Soreness (DOMS)) using 0-10 Visual Analog Scale (VAS).
Time Frame: Baseline, Week 8
Secondary Outcomes
- To evaluate the effects of KSM-66 Ashwagandha formulations on cardiorespiratory endurance (time to exhaustion using the Bruce Protocol) using motorized treadmill.(Baseline, Week 8)
- To evaluate the effects of KSM-66 Ashwagandha formulations on measurement in arm circumference (muscle size).(Baseline, Week 8)
- To evaluate the effects of KSM-66 Ashwagandha formulations on change in body-composition using Bioelectrical Impedance Analysis (BIA). [(Baseline, Week 8)
- To evaluate the effect of the KSM-66 Ashwagandha formulation on Quality of Life (QoL) using the Short Form-12 tool.(Baseline, Week 8)
- To evaluate the effects of KSM-66 Ashwagandha formulations on serum hormones (Sr. Creatinine kinase, Testosterone).(Baseline, Week 8)
- To evaluate the safety of KSM-66 Ashwagandha formulations on Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters.(Baseline, Week 8)
- To evaluate the safety of KSM-66 Ashwagandha formulations on Renal (serum creatinine, blood urea nitrogen) parameters(Baseline, Week 8)
- To evaluate the safety of KSM-66 Ashwagandha formulations on Treatment-Emergent Adverse Events (TEAE)/ Treatment-Emergent Serious Adverse Events (TESAE).(Baseline, Week 4, Week 8)
Investigators
DrAnup Krishnan J
D Y Patil Hospital,Nerul
Study Sites (1)
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