| CTRI Number |
CTRI/2011/12/002278 [Registered on: 22/12/2011] Trial Registered Prospectively |
| Last Modified On: |
08/09/2012 |
| 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 clinical trial to study the efficacy and safety of standardized Withania somnifera extract in chronically stressed subjects |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, 4-arm, parallel group study to evaluate the efficacy and safety of standardized Withania somnifera extract in chronically stressed subjects |
| Trial Acronym |
WISOMECS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandhya Kamat |
| Designation |
Professor, Dept of Pharmacology and Therapeutics |
| Affiliation |
Seth GS Medical College and KEM Hospital Parel Mumbai |
| Address |
Dept of Pharmacology and Therapeutics,
1st floor, College Bldg,
Seth GS Medical College and KEM Hospital,
Acharya Donde Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-022-24107444 |
| Fax |
91-022-24121711 |
| Email |
drsandhyakamat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muruganandam AV |
| Designation |
Director (R&D) |
| Affiliation |
Natreon Inc, Kolkata |
| Address |
Natreon Inc, Research & Development Centre, CL18 A, Sector-II,
Salt Lake City
Kolkata
WEST BENGAL
700091
India |
| Phone |
91-033-23371920 |
| Fax |
91-033-23371910 |
| Email |
muru_av@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipankar Banerjee |
| Designation |
Manager (R&D) |
| Affiliation |
Natreon Inc |
| Address |
Natreon Inc, Research & Development Centre, CL 18 A, Sector-II
Salt Lake City
Kolkata
WEST BENGAL
700091
India |
| Phone |
91-033-23371920 |
| Fax |
91-033-23371910 |
| Email |
dipankar66@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Natreon Inc, Research & Development Centre,
Kolkata |
|
|
Primary Sponsor
|
| Name |
Natreon Inc Research And Development Centre |
| Address |
Natreon Inc, Research And Development Centre,
CL - 18A, Sector II, Salt Lake City, Kolkata-700091
Ph.No. 91-033-2337- 1920; Fax: 91-033-2337-1910
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Sandhya Kamat |
MEDICINE OPD, PSYCHIATRY OPD & AYURVEDA OPD |
Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel,
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA |
022-24107444
drsandhyakamat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects, Seth GS Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronically stressed patients
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
2 Placebo capsules |
| Intervention |
Standardized Withania somnifera extract |
1 capsule of 125 mg WSE + 1 Placebo capsule
|
| Intervention |
Standardized Withania somnifera extract |
2 capsules of 250 mg WSE |
| Intervention |
Standardized Withania somnifera extract |
2 capsules of 125 mg WSE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects meeting all the following criteria will be included in the study
1. Subjects between the age group of 18 – 70 years of either sex.
2. Subjects who fit into either Grades 1, 2 and 3 on the Objective physical health scale (ref: Vaillant GE, Mukamal K. Successful Aging. Am J Psychiatry 2001; 158:839–847)
3. Subjects who are stable on medications with no change in medication in the last 4 weeks and who have the results of the following investigations in the standard laboratory range (± 10%) : Hb, CBC, ESR, Urine
4. Subjects who have a mHAM-A of > 28 for physical symptoms and > 19 for cognitive/ mood/ behavioural symptoms.
5. Women should have a negative urine pregnancy test at screening and should be willing to use adequate methods of contraception (OC pills /double barrier methods) or should have no childbearing potential (surgically sterilized or postmenopausal for 1 year).
6. Subjects ready to abide by trial procedures and willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
Subjects presenting with any of the following criteria will be excluded from the study.
1. Subjects who are taking antidepressant, antipsychotic and anxiolytic medications.
2. Subjects with a history of intake of any herbal / ayurvedic/ homeopathic medicines for any indication. in the last one month.
3. Subjects with a presence of clinically significant laboratory abnormality at screening e.g. significant abnormality of Liver Function Test (more than 2.5 times upper limit of normal) & Renal Function Test (more than 1.5 times upper limit of normal).
4. Subjects with drug/alcohol addictions
5. Subjects who have received in the 3 months prior to screening any systemic glucocorticoid treatment.
6. Subjects with history of hospital admission (hospital stay > 24 hours) with medical/surgical complications in the last1 month.
7. Subjects with history of infectious diseases in the last 1 month
8. Subjects with any known hypersensitivity to the components of the test medicine.
9. Women who are pregnant or breastfeeding or fertile women who are not practicing adequate methods of contraception (OC pills /double barrier methods).
10. Subjects who have received any investigational drug within the previous 1 month.
11. Subjects who are simultaneously participating in any other clinical trial.
12. Subjects with any other condition which in the opinion of the investigator would make the him/her unsuitable for the study or compromise his/her safety.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary efficacy end-points are
• Change in mHAM-A scores at day 60 from the baseline.
|
0 days
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluate safety of standardized WSE.
2.To assess the percentage of subjects achieving a mHAM-A of 28 for physical symptoms and 19 for cognitive/ mood/ behavioural symptoms with standardized WSE as compared to placebo on day 60.
3.Evaluate the change in the mean score of each component of Clinical Global Impressions (CGI) scale as compared to placebo
|
0 days
30 days
60 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2012 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Chronic stress, like aging, is ubiquitous and an accepted part of life. Existing evidence supports stress as a risk factor for depression, cardiovascular disease, peptic ulcer disease, delayed wound healing, and morbidity and mortality. The use of current pharmacological agents in management of stress is limited by adverse effects such as insomnia, anxiety, irritability and decreased libido which affects the patient’s quality of life. Withania somnifera has been found to reduce stress induced syndromes ranging from anxiety, depression, hyperglycemia, immunomodulation and adrenocortical activation. Withania somnifera has been extensively used by Ayurvedic physicians for its balavardhak (improvement in physical strength) and dhatupousthik (nourishes the dhatus) properties as a rejuvenator. Standarized Withania somnifera extract (WSE) is a patented extract, prepared from a specific chemotype of Withania somnifera, showing significant antistress, antioxidant and antidepressive actions as determined in animals in different experimental models. The effects of WSE have been shown to be beneficial in stressed individuals. However clinical studies assessing the efficacy and safety of WSE in stressed individuals remains scarce. Hence a randomized, double-blind, placebo controlled, 4 – arm, parallel group study has been designed to evaluate the efficacy and safety of standardized WSE in chronically stressed subjects. The objective of the study is to evaluate the change in the modified Hamilton Anxiety Score (mHAM-A) from baseline following 60 days of oral dosing with standardized WSE versus placebo in chronically stressed subjects. |