| CTRI Number |
CTRI/2025/02/081079 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral
Other (Specify) [Councelling ] |
| Study Design |
Other |
|
Public Title of Study
|
Role of lifestyle modifications in management of depression. |
|
Scientific Title of Study
|
Exploring the interplay between sadvritta and its role in the management of vishaada (Depression):A multidimensional analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bornali Biswas |
| Designation |
Post graduate scholar |
| Affiliation |
Government Ayurvedic College and Hospital Guwahati Assam |
| Address |
Department of Samhita and Siddhant, Government Ayurvedic College and Hospital Guwahati Assam
Kamrup
ASSAM
781014
India |
| Phone |
7636841767 |
| Fax |
|
| Email |
bornalibiswas30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karab Ali |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurvedic College and Hospital Guwahati Assam |
| Address |
Department of Samhita and Siddhant, Government Ayurvedic College and Hospital Guwahati Assam
Kamrup
ASSAM
781014
India |
| Phone |
9706042247 |
| Fax |
|
| Email |
drkarabali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karab Ali |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurvedic College and Hospital Guwahati Assam |
| Address |
Department of Samhita and Siddhant, Government Ayurvedic College and Hospital Guwahati Assam
ASSAM
781014
India |
| Phone |
9706042247 |
| Fax |
|
| Email |
drkarabali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Guwahati ,Assam ,India, Pincode 781014. |
|
|
Primary Sponsor
|
| Name |
Bornali Biswas |
| Address |
Department of Samhita and Siddhant, Government Ayurvedic College and Hospital, Guwahati, Assam , India, Pincode 781014. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Karab Ali |
Government Ayurvedic College and Hospital Guwahati Assam |
Jalukbari, AEC road , Guwahati, Assam, India,pincode 781014
Kamrup
ASSAM |
9706042247
drkarabali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F331||Major depressive disorder, recurrent, moderate. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of depression as per DSM V criteria will be selected for the present research work irrespective of gender. |
|
| ExclusionCriteria |
| Details |
Patients below 18 years of age and above 70 years will be excluded.Severe psychiatric problems,severe cognitive problems, bedridden patients, patients using oral antidepressants will be excluded during the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will be done to observe the effects of sadvritta on the patients diagnosed with depression having mild to moderate symptoms by councelling them . Patients will be diagnosed on basis of hamilton depression rating scale . The scores will be recorded before and after treatment which will further decide the effect of treatment on the patient. |
The patient will be under the trial for a period of 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The patients will undergo the treatment through four subsequent follow up after every 15 days till completion of sixty days . |
The first follow up will be after 15 days after first visit , the next on 30 th day, then 45th day and lastly 60th day. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be done to find out the applicability of sadvritta in management of vishaada (depression) on a sample size of 30 patients of OPD and IPD of Government Ayurvedic College and Hospital Guwahati Assam in the age group of 18 to 70 years irrespective of gender for a period of 60 days . The management will be done by councelling the patients about sadvritta and its application in lifestyle modifications who are suffering from depression . The scores before and after treatment will be recorded as per hamilton depression rating scale . |