| CTRI Number |
CTRI/2024/09/073960 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety of Ashwagandha (Withania Somnifera) Root Extract on Muscle Strength and Endurance in Healthy Athletes: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KSM-1059-2024-01Version 1.0; dt. 19th Jul 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnup Krishnan J |
| Designation |
Principle investigator |
| Affiliation |
D Y Patil Hospital,Nerul |
| Address |
Room no. 5, Ground floor, School of Medicine Building
D Y Patil University School of Sports, Exercise, and Nutritional Sciences
Sector 5, Nerul, Navi Mumbai 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9158999169 |
| Fax |
|
| Email |
anup.krishnanj@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnup Krishnan J |
| Designation |
Principle investigator |
| Affiliation |
D Y Patil Hospital,Nerul |
| Address |
Room No. 5, Ground floor, School of Medicine Building
D Y Patil University School of Sports, Exercise, and Nutritional Sciences
Sector 5, Nerul, Navi Mumbai - 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9158999169 |
| Fax |
|
| Email |
anup.krishnanj@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrAnup Krishnan J |
| Designation |
Principle investigator |
| Affiliation |
D Y Patil Hospital,Nerul |
| Address |
Room No. 5, Ground Floor, School of MEdicine Building
D Y Patil University School of Sports, Exercise, and Nutritional Sciences
Sector 5, Nerul, Navi Mumbai - 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9158999169 |
| Fax |
|
| Email |
anup.krishnanj@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed Private Limited, 5-9-225, Sanali Estate, Abids, Hyderabad – 500001, India. |
|
|
Primary Sponsor
|
| Name |
Ixoreal Biomed Private Limited |
| Address |
5-9-225, Sanali Estate, Abids, Hydrabad-500001 Ph:(91)40-23204385/86/87 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anup Krishnan |
D Y Patil Hospital,Nerul |
Room No. 5, Ground Floor, D Y Patil University School of Medicine, Sector 5, Nerul, Navi Mumbai - 400706
Thane
MAHARASHTRA |
09158999169
anup.krishnanj@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IInstitute Ethics Committee D Y Patil Medical College Nerul Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy athletes |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwagandha, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Capsule | Identical Capsule containing
starch 300 mg |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female subjects with age from 18 to 45 years who are healthy athletes
2.
Ability to understand the risks and benefits of the protocol
3.
Subject with a history of gymnasium visits since the last three months of screening
4.
Subject willing to follow the same exercise and diet regime for the study period as prescribed by the study protocol
5.
Subject who has given written informed consent to participate in the study and understand the nature of the study
6.
Able to read and write in English or any other vernacular language
7.
No plan to commence new treatments over the study period.
8.
Must have the ability and willingness to sign an informed consent and to comply with all study procedures. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To evaluate the effects of KSM-66 Ashwagandha formulations on muscle recovery (Delayed-Onset Muscle Soreness (DOMS)) using 0-10 Visual Analog Scale (VAS). |
Baseline, Week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
|