| CTRI Number |
CTRI/2020/06/025741 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
08/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the ayurvedic medicine Medhavati with allopathic medicine sertraline for the treatment of Depression. |
|
Scientific Title of Study
|
A Prospective, Randomised, Comparative clinical study to Evaluate the Efficacy and Safety of Ayurvedic Medicine Medha Vati & Allopathic Medicine Sertraline in the Management of Depression. |
| Trial Acronym |
Medha Vati Sertraline Depression |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tushar Jagawat |
| Designation |
Professor and Head, Psychiatry |
| Affiliation |
NIMSR JAIPUR |
| Address |
Department of Psychiatry NIMSR Jaipur
Jaipur
RAJASTHAN
303121
India |
| Phone |
09928048586 |
| Fax |
|
| Email |
tusharjagawat@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Jagawat |
| Designation |
Professor and Head, Psychiatry |
| Affiliation |
National institute of medical sciences and research, Jaipur |
| Address |
Department of Psychiatry, National Institute of Medical Sciences & Research, Jaipur
Jaipur
RAJASTHAN
303121
India |
| Phone |
09928048586 |
| Fax |
|
| Email |
tusharjagawat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenaxi Sharma |
| Designation |
Principal |
| Affiliation |
National institute of Medical Sciences & Research Jaipur |
| Address |
National Institute of Medical Sciences & Research Jaipur
Jaipur
RAJASTHAN
303121
India |
| Phone |
9784371780 |
| Fax |
|
| Email |
drmeenaxi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Medical Sciences & Research ,JAIPUR |
|
|
Primary Sponsor
|
| Name |
National Institute of Medical Sciences Research Jaipur |
| Address |
National Institute of Medical Sciences & Research, Jaipur |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Patanjali Yogpeeth Haridwar |
Patanjali Yogpeeth Haridwar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tushar Jagawat |
Nims Hospital, Jaipur |
OPD NO.2 Department of Psychiatry National Institute of Medical Sciences & Research, Jaipur
Jaipur
RAJASTHAN |
09928048586
tusharjagawat@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oral tablet medhavati |
2 tablets twice daily to be taken post meals with water/milk for 12 weeks depending on improvement of symptoms |
| Intervention |
oral tablet sertraline |
50mg once in a day for 12 weeks depending on the improvement of symptoms |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients newly diagnosed as Depression of age 20-60 years as per icd-10 criteria with written informed consent by the patients. The HAM-D will be used to assess the severity of Depression. |
|
| ExclusionCriteria |
| Details |
1 Age less than 20 years and more than 60 years
2 Pregnant and lactating women
3 Major medical chronic disorders
4 Severe depression with psychotic features or suicidal risks
5 Patient who do not give consent for the study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction In Depressive Symptoms In HAM-D Score |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Satisfactory Improvement In Depressive Symptoms In HAM-D Score |
3 Months |
|
|
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)
|
22/06/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This Study is a Randomised Interventional trial to compare the Safety and Efficacy of Ayurvedic Medicine Medha Vati and Allopathic Medicine Sertraline in patients of Depression as per inclusion and exclusion criteria of the study. The study will be conducted at Psychiatry OPD of NIMSR, JAIPUR . The primary outcome measure will be reduction of Depressive score in HAM-D scale in 4 weeks and secondary outcome will be Satisfactory Reduction in HAM-D score in 12 weeks. |