| CTRI Number |
CTRI/2021/10/037119 [Registered on: 06/10/2021] Trial Registered Prospectively |
| Last Modified On: |
05/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [psychotherapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A psychological intervention to study the effects of Sattvavjava Chikitsa and Cognitive behaviour therapy in depressive patients. |
|
Scientific Title of Study
|
A randomised controlled study to evaluate the efficacy of Sattvavjava Chikitsa and Cognitive Behaviour therapy (CBT) in the management of Major depressive disorder. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JS Tripathi |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of Medical sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838706393 |
| Fax |
|
| Email |
drjstripathi@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dipinti Singh |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of medical sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7084872579 |
| Fax |
|
| Email |
dipintisingh55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dipinti Singh |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of medical sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7084872579 |
| Fax |
|
| Email |
dipintisingh55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council of Research in Ayurvedic Sciences |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of medical sciences
Banaras Hindu University
Varanasi, 221005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DIPINTI SINGH |
SS HOSPITAL BHU |
DEPARTEMENT OF KAYACHIKITSA, FACULTY OF AYURVEDA, INSTITUE OF MEDICAL SCIENCES, BANRAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH |
7084872579
dipintisingh55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human ethical committee, institute of medical sciences, Banaras Hindu University |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Cognitive behavioral therapy | Cognitive behavioral intervention teaches learners to examine their own thoughts and emotions, recognize when negative thoughts and emotions are escalating in intensity, and then use strategies to change their thinking and behavior. | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Sattvavjava Chikitsa, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i.The patients to have met the DSM-V diagnostic criteria for MDD (will be assessed by the referring clinician).
ii.In this study only mild to moderate cases of depression will be taken.
|
|
| ExclusionCriteria |
| Details |
i. Depression with comorbid serious somatic illness, e.g., myocardial infarction, multiple sclerosis, cerebral stroke, hypothyroidism, cancer, etc.
ii. Drug or alcohol dependence related depression.
iii. Pregnancy related depression postpartum depression, postnatal depression, etc.
iv. Depression with psychotic symptoms e.g., delusions or hallucinations, incoherence, marked loosening of associations etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the clinical sign and symptoms.
Reduction of the scores of HDRS. Overall improvement of WHO quality of life. |
Psycho-therapy trial will be conducted for total period of three months with 12 session and each session will be lasting 60 minutes follow ups were recorded each at one month interval for three consecutive months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| positive and promotive improvement in the mental health |
90 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 3 |
|
Date of First Enrollment (India)
|
06/10/2021 |
| 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="2"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
The research work is based on the patients suffering from MDD visiting to Sir Sundrlal Hospital, BHU, Varanasi under the supervision of Prof. J.S. Tripathi , Department of kayachikitsa and Co- Supervision of Prof. J.S. Yadav, Department of Psychiatry , Institute of Medical Sciences, Banaras Hindu University, Varanasi. This is interventional study in which two psychotherapy viz cognitive Behaviour Therapy and Sattvavajava Chikitsa has been selected. Study is being conducted on 120 patients with Major Depressive Disorders randomly divided into 2 group. Diagnosed cases of MDD are being registered from O.P.D. of Divison of Manas Rog ( Neuro- Psychiatry & Psychosomatic Medicine), department of Kayachikitsa, SS Hospital, IMS, BHU, Varanasi. Hamilton Depression Rating Scale and WHO Quailty of Life Bref assessment Parameters are being used to assessment severity of depression and overall subjective well being of patients with MDD. |