| CTRI Number |
CTRI/2016/10/007353 [Registered on: 13/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
14/08/2014 |
| 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) in stress disorder |
|
Scientific Title of Study
|
Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) In Stress Disorders in Healthy Adults: A Prospective, Randomized, Double-Blind Placebo Controlled Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KSM/Stress/Ad/02/2013, version 1, dated 3rd Aug 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dnyanraj Choudhary |
| Designation |
Principal Investigator |
| Affiliation |
Atur Sangtani |
| Address |
Atur Sangtani, Red Cross House, 11 M.G.Road,
Pune MAHARASHTRA 411001 India |
| Phone |
9823217423 |
| Fax |
|
| Email |
dr.dnyanrajc@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dnyanraj Choudhary |
| Designation |
Principal Investigator |
| Affiliation |
Atur Sangtani |
| Address |
Atur Sangtani, Red Cross House, 11 M.G.Road,
MAHARASHTRA 411001 India |
| Phone |
9823217423 |
| Fax |
|
| Email |
dr.dnyanrajc@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Dnyanraj Choudhary |
| Designation |
Principal Investigator |
| Affiliation |
Atur Sangtani |
| Address |
Atur Sangtani, Red Cross House, 11 M.G.Road,
MAHARASHTRA 411001 India |
| Phone |
9823217423 |
| Fax |
|
| Email |
dr.dnyanrajc@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 Dnyanraj Choudhary |
Atur Sangtani |
Red cross house, consulting room No. 1, Atur sangatani,11 M.G.Road, Pune 411001. Pune MAHARASHTRA |
9823217423
dr.dnyanrajc@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. Dnyanraj Choudhary |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress disorder |
|
|
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 |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult male or female patients aged between 18 – 60 years of age
2.Patients with routine work stress
3.Patients stress disorders characterized with difficulty in concentration, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, phobia, sweating, mental confusion etc.
4.Patients with Perceived Stress Scale (PSS) score more than or equal to 20 (high stress level)
5.Body mass index between 25 and 39.9 kg/m2
|
|
| ExclusionCriteria |
| Details |
1.Participants who have a diagnosable eating disorder will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data
2.Currently (in the past three months) attending a weight loss program
3.Underlying genetic or endocrine cause for weight gain
4.Medications known to affect weight (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications)
5.History of Alcohol or smoking abuse
6.Have clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
7.Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania
8.Patients with post traumatic disorder
9.Have an established practice of meditation for three or more months
10.Pregnant and lactating women
11.Subjects with known hypersensitivity to Ashwagandha
12.Participation in other clinical trials during previous 3 months
13.Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol
|
|
|
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 Perceived Stress Scale score (PSS) after 8 weeks. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement from baseline in the score for Oxford Happiness Scale after therapy |
baseline, week 4 and week 8 |
| Improvement from baseline in urine cortisol level |
baseline, week 4 and week 8 |
| Change in Weight |
baseline, week 4 and week 8 |
| Change from baseline in vital signs |
8 weeks |
| Body mass index (BMI) and absolute and percentage weight loss will be compared. |
8 weeks |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/11/2013 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
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 study
is A prospective, randomized, double-blind,
placebo-controlled study to compare the efficacy of Ashwagandha in stress
disorder in healthy adults. A total of 50 healthy adults subjects will be recruited in this study. Adult male
or female subjects between 18 to 60 years of age, with routine work stress, stress disorders characterized with difficulty
in concentration, physical exhaustion, anxiety, restlessness, insomnia, headache,
fatigue, loss of appetite, phobia, sweating, mental confusion etc. ,
Perceived Stress Scale (PSS) score more than or equal to 20 and Body mass index
between 25 and 39.9 kg/m2 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 Perceived Stress Scale
score (PSS) after therapy and secondary outcome as improvement from baseline in
the score for Oxford Happiness Scale and urine cortisol level. Change in
Weight, vital signs and Body mass index (BMI) and
absolute and percentage weight loss will be compared 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.
|