| CTRI Number |
CTRI/2014/02/004422 [Registered on: 19/02/2014] Trial Registered Retrospectively |
| Last Modified On: |
08/01/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of Ashwagandha (Withania somnifera) on Muscle Strength, Endurance and Recovery during Resistance Exercise in Healthy Male Adults |
|
Scientific Title of Study
|
Effect of KSM66 Ashwagandha (Withania somnifera) on Muscle Strength, Endurance and Recovery during Resistance Exercise in Healthy Male Adults: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KSM/MR/Exer/03/2013, version 1, dated 7th Aug 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin Wankhede |
| Designation |
Principal Investigator |
| Affiliation |
Doctors Fitness Zone, |
| Address |
Parmar tradecentre,
Sadhu Vaswanichowk,
12 Connaught road,
Pune
MAHARASHTRA
411001
India |
| Phone |
9823039390 |
| Fax |
|
| Email |
sachin30wankhede@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Wankhede |
| Designation |
Principal Investigator |
| Affiliation |
Doctors Fitness Zone, |
| Address |
Parmar tradecentre,
Sadhu Vaswanichowk,
12 Connaught road,
MAHARASHTRA
411001
India |
| Phone |
9823039390 |
| Fax |
|
| Email |
sachin30wankhede@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Wankhede |
| Designation |
Principal Investigator |
| Affiliation |
Doctors Fitness Zone, |
| Address |
Parmar tradecentre,
Sadhu Vaswanichowk,
12 Connaught road,
MAHARASHTRA
411001
India |
| Phone |
9823039390 |
| Fax |
|
| Email |
sachin30wankhede@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shri Kartikeya Pharma |
| Address |
5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (0091) 40-23204385 / 86 / 87 |
| 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 Sachin Wankhede |
Doctors Fitness Zone |
Parmar tradecentre,
Sadhu Vaswanichowk,
12 Connaught road, Pune-41 1001
Pune
MAHARASHTRA |
9823039390
sachin30wankhede@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Chaitanya Hospital and Nursing Home, Pune for Dr. Sachin Wankhede |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Muscle Strength |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KSM-66 (Withania somnifera) |
One capsule twice daily orally for 8 weeks |
| Comparator Agent |
Placebo |
Placebo capsule identical to KSM 66 (Withania somnifera) but without active ingredients.One capsule twice daily orally for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1.Adult males between 18 – 50 years of age
2.Subjects with physical training activity or gymnasium activity of at least 5 hours in a week
3.Subjects willing to restrain from alcohol and smoking during the study period
4.Subjects have the ability to understand the requirements of the study
5.Subjects agree to abide by the study activities, requirements and restrictions and willing to return for the required assessments
6.Subjects willing to sign informed consent |
|
| ExclusionCriteria |
| Details |
1.Females
2.Subjects taking any medication, drugs, steroids or protein supplements (excluding regular dietary protein) in any form to enhance the physical performance
3.Subjects with active weight loss of >5 kg in past 3 months (intended or unintended
4.Subject has a history of medical or surgical events that may affect the study outcome or place the subject at risk, including cardiovascular disease, gastrointestinal problems, metabolic, renal, hepatic, neurological or active musculoskeletal disorders
5.Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day)
6.history of regular alcohol intake i.e. with atleast one alcoholic beverage (14gm/day) per day (‘regular drinkers’)
7.Subjects with a history of any drug dependence or substance abuse
8.Subjects with known hypersensitivity to Ashwagandha
9.Subject with a history of any orthopedic injury within the past 6 months
10.Subjects with a history of any major surgery within the past 6 months
11.Participation in other clinical study during previous 3 months
12.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement from baseline in the muscular strength and endurance after 8 weeks |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Muscle size from baseline |
8 weeks |
| Improvement in the body composition from baseline using BIA |
8 weeks |
| • Improvement from baseline in the muscle damage during resistance exercise analyzed by measuring the serum creatinine kinase (CK) 24 hours after the exercise |
8 weeks |
| Change in the serum testosterone |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/11/2013 |
| 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 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study
is A prospective, randomized, double-blind, placebo-controlled study to assess
the Effect of KSM66 Ashwagandha (Withania somnifera) on muscle strength,
endurance and recovery during resistance exercise in healthy male adults.A total of
50 healthy male volunteers will be recruited in this study with 25 in each of
the two treatment groups. Adult male or female subjects between 18 to 50 years
of age, with physical training activity or gymnasium activity of at least 5
hours in a week, willing to restrain from alcohol and smoking during the study
period and agree to abide by the study
activities, requirements and restrictions and willing to return for the
required assessments will be
enroll in study. Study duration will be 8 weeks for each subject with baseline,
week 4 & week 8 visits. Subjects were asked to take 1 capsule two times
daily (total 2 capsules per day) with water daily for 8 weeks. At the end of
study primary outcome will be assessed as Improvement from
baseline in the muscular strength
and endurance and secondary outcome
as improvement from baseline in muscle
size, body composition, muscle
damage and Changes in serum testosterone after therapy. Safety will be assessed by evaluation of adverse
events reported by the patients during the study and Global assessment of
tolerability will be performed by physician at the end of study.
|