| CTRI Number |
CTRI/2012/05/002670 [Registered on: 18/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
20/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate effiacy and safety of KSM-66 Ashwagandha (Withania somnifera) on improving cardiorespiratory endurance in healthy athletic adults |
|
Scientific Title of Study
|
A Randomized, Prospective, Double Blind, Placebo Controlled Study to Evaluate Efficacy
and Safety of KSM-66 Ashwagandha (Withania somnifera) on Improving Cardio
Respiratory Endurance in Healthy Athletic Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Maj Dr S Bakhtiar Choudhary |
| Designation |
Principal Investigator |
| Affiliation |
Hyderabad Spine Clinic |
| Address |
Hyderabad Spine Clinic,
Gulmohar Marg Avenue,
Rajbhavan Road, Hyderabad-500082
Andhra Pradesh, India.
Hyderabad
ANDHRA PRADESH
5000082
India |
| Phone |
040-656470104 |
| Fax |
|
| Email |
sbakhtiar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDMRavichand |
| Designation |
Director, Medical Operations |
| Affiliation |
MakroCare Clinical Research Limited |
| Address |
MakroCare Clinical Research Limited, Hyderabad – 500033,Andhra Pradesh, India.
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
040-44346666 |
| Fax |
040-44346667 |
| Email |
ravichand.devulach@makrocare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanchita Das |
| Designation |
Project Manager - Clinical operations |
| Affiliation |
MakroCare Clinical Research Limited |
| Address |
MakroCare Clinical Research Limited, Hyderabad
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
040-44346666 |
| Fax |
040-44346667 |
| Email |
sanchita.das@makrocare.com |
|
|
Source of Monetary or Material Support
|
| SKP Labs Private Limited,
5-9-225, Sanali Estate,
Abids, Hyderabad |
|
|
Primary Sponsor
|
| Name |
SKP Labs Private Limited |
| Address |
5-9-225, Sanali Estate,
Abids, Hyderabad |
| 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 |
| Prof Maj Dr S Bakhtiar Choudhary |
Hyderabad Spine Clinic |
Gulmohar Marg Avenue,
Rajbhavan Road, Hyderabad
Hyderabad
ANDHRA PRADESH |
040656470104
sbakhtiar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SURAKSHA INDEPENDENT ETHICS COMITTIEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CARDIORESPIRATORY ENDURANCE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KSM66 ashwagandha |
The test formulation contains powdered Ashwagandha 300 mg filled in hard gelatin capsules which will be administered orally (b.i.d.) one capsule in the morning and one capsule in the evening. It should be taken after food with a full glass of water. Duration of study is 90 days. |
| Comparator Agent |
placebo |
The placebo formulation contains starch powder 300 mg filled in hard gelatin capsules which will be administered orally (b.i.d.) one capsule in the morning and one capsule in the evening. It should be taken after food with a full glass of water. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy athletic adults of male and female subjects aged
between 20 and 45 years.
2. 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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
The change in the 20M shuttle run test score from Visit 0 to after
Day 56 (Visit 2) and Day 84 (Visit 3) of treatment. |
day 0, day 28, day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety will be assessed from the number of adverse events
occurred and judging their causal relationship to the study drug.
– The change in the Borg scale score, after Visit 0 to after Day 56
(Visit 2) and Day 84 (Visit 3) of treatment.
– Quality of life (QOL) of improvement. |
day 0 day 28, day 56, day 84 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |