| CTRI Number |
CTRI/2018/07/014969 [Registered on: 19/07/2018] Trial Registered Prospectively |
| Last Modified On: |
08/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
To study the effect of Ashwagandha capsules(300mg) on Muscle Strength and Recovery in Sports Persons |
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Scientific Title of Study
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A Randomized Double Blind Placebo Controlled Comparative Study to Evaluate the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) Capsules 300 mg on Muscle Strength and Recovery in Sports Persons |
| Trial Acronym |
KSM-66/PMS/2017/01,v1.1 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KSM-66/PMS/2017/01 v1.1 19Mar 2018 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Nitish Sharma |
| Designation |
Bussiness development & Medical affairs |
| Affiliation |
Shri Karthikeya Pharma |
| Address |
Department of Medical Affairs PBN Center, 8-2-293/82/A/1057-F, 3rdFloor, Road No 45, Jubilee Hills, Hyderabad
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
914023204385 |
| Fax |
|
| Email |
nitish@ixoreal.com |
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Details of Contact Person
Public Query
|
| Name |
Pawan Bhusari |
| Designation |
CEO |
| Affiliation |
Abiogenesis Clinpharm Pvt Ltd |
| Address |
Abiogenesis Clinpharm Private Limited
8-2-596A & B/1, Road No. 10, Banjara Hills,
Hyderabad,TS–500034
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
91-40-38117077 |
| Fax |
91-40-38117078 |
| Email |
pawanbhusari@abiogenesisclinpharm.com |
|
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Source of Monetary or Material Support
|
| Shri Kartikeya Pharma
1057/F1, 45th Rd,, 45th Rd, Nandagiri Hills, Jubilee Hills, Hyderabad, Telangana 500096 |
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Primary Sponsor
|
| Name |
Shri Kartikeya Pharma |
| Address |
Shri Kartikeya Pharma, PBN Center, 8-2-293/82/A/1057-F , 3rd Floor, Road no 45, Jubilee Hills, Hyderabad, Telangana 500033 |
| Type of Sponsor |
Other [neutraceutical] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Kumar Gupta |
M V Hospital & Research Centre |
General Physician, Department of Medicine, 1st floor
M V Hospital & Research Centre ,314/30, Mirza Mandi, Chowk
Lucknow- 226003
Lucknow
UTTAR PRADESH |
05222258215
sandeepkumar.gupta@rediffmail.com |
| Dr N S Verma |
King George Medical University |
Room Number 01,1st Floor,Department of Physiology,
King George Medical University,
Chowk, Lucknow-226003 Uttar Pradesh
India.
Lucknow
UTTAR PRADESH |
05222257542
narsinghverma@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institional Ethics committee for King George Medical University Lucknow |
Approved |
| Institional Ethics committee for MV hospital and research centre |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Healthy Human Volunteers |
sports persons |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
KSM-66 Ashwagandha (withania Somnifera |
KSM66 300mg capsules
twice daily (morning & evening)
Orally |
| Comparator Agent |
Placebo |
Placebo capsules 300mg
twice daily (morning & evening)
orally
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects with age from18 to 45 years who are sports persons
2. Willing to provide EC approved written informed consent.
3. Ability to understand the risks and benefits of the protocol
4. Subject with History of Gymnasium visit since last three months of Screening
5. Subject willing to follow the same Exercise and diet regime for study period as prescribed by the study protocol
6. Men and women of childbearing potential accepting to use adequate birth control measures, as discussed with the study doctor, until the end of study.
7. Subjects with good health as determined by:
8. Medical history
9. Physical examination
10. Clinical judgment of the investigator
11. Clinical laboratory examination (subjects with clinically acceptable range during baseline screening)..
|
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| ExclusionCriteria |
| Details |
1. Subjects already on nutritional / Energy supplements, medication or steroids to enhance physical performance
2. Any history of drug abuse, smoking 10+ cigarettes 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 >5kg in the past 3 months
5. History of any orthopedic injury or surgery in the past 6 months
6. Participation in any clinical studies in the past 3 months
7. Subject diagnosed with heart disease, diabetes, stroke or other neurological disorders or depression
8. Subject with significant medication use (blood pressure, beta-blockers, inhaled beta agonists, hormonal contraceptives, corticosteroid use within prior three months, psychotropic medication use within prior eight weeks)
9. Hypersensitivity to Ashwagandha
10. Subjects with history of any prohibited drugs use
11. Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in muscle strength from baseline to EOS |
8 weeks from baseline visit |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
a) Levels of total testosterone men/ women and free testosterone men/ women
b) Muscle recovery and anthropometric factors
c) Muscle size
d) Endurance.
|
8 weeks from baseline visit |
|
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Target Sample Size
|
Total Sample Size="80"
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" |
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Phase of Trial
|
Post Marketing Surveillance |
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Date of First Enrollment (India)
|
23/07/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
|
none yet |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a prospective, double-blind, multi centric, randomized, placebo-controlled parallel-group study. In all, 80 (40 male and 40 female) subjects will be randomized by stratified randomization technique in order to enroll subjects in a targeted ratio of 1:1 (test: placebo). Test group and placebo group will have approximately equal number of male and female subjects. Healthy subjects who had a history of gymnasium visit in the past three months and are willing to provide written informed consent will be randomly assigned in a double-blind fashion to one of the two treatment groups. An independent third-party dispenser who is not performing clinical evaluations will dispense the blinded study medication. The IP will be administered for a period of eight weeks. At baseline and End of Study visits, the same investigator, when possible, will assess and record the Quality of life (SF-36 questionnaire). In addition, muscle size and strength, treadmill performance, testosterone level, hematology and serum chemistry will be evaluated. Safety will be assessed by monitoring adverse events (AEs). |