CTRI Number |
CTRI/2023/07/054596 [Registered on: 03/07/2023] Trial Registered Prospectively |
Last Modified On: |
29/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Vamana Dhauti as an add on treatment in Depression- a Pilot RCT |
Scientific Title of Study
|
Feasibility and Tolerability of Vamana Dhauti as an add-on treatment in patients with Depression: a Pilot Randomized Controlled Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Aditi Garg |
Designation |
Post graduate student |
Affiliation |
NIMHANS |
Address |
Third floor, New yoga building, Department of Integrative Medicine, NIMHANS
Bangalore KARNATAKA 560029 India |
Phone |
8197724152 |
Fax |
|
Email |
draditigargnaturo@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Kishore Kumar Ramakrishna |
Designation |
Head of Department and Guide |
Affiliation |
NIMHANS |
Address |
First floor, Ayurveda block, Department of Integrative Medicine
Bangalore KARNATAKA 560029 India |
Phone |
|
Fax |
|
Email |
ayurkishore@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kishore Kumar Ramakrishna |
Designation |
Head of Department and Guide |
Affiliation |
NIMHANS |
Address |
First floor, Ayurveda block, Department of Integrative Medicine
Bangalore KARNATAKA 560029 India |
Phone |
|
Fax |
|
Email |
ayurkishore@yahoo.com |
|
Source of Monetary or Material Support
|
Department of Integrative Medicine,National Institute of MentalHealth and Neuroscience |
|
Primary Sponsor
|
Name |
Dr Aditi Garg |
Address |
Third floor, New yoga building, Department of Integrative Medicine, NIMHANS |
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 |
Dr Aditi Garg |
National Institute of Mental Health and Neurosciences |
Department of Integrative Medicine, NIMHANS Bangalore KARNATAKA |
8197724152
draditigargnaturo@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Human Ethics Committee for Research in AYUSH and Integrative Medicine |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (2) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (3) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (4) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, (5) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (6) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (7) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (8) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, (9) ICD-10 Condition: F30-F39||Mood [affective] disorders, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Shavasana only |
Shavasana rest only on day one followed by six days of yoga practice from day two to day seven |
Intervention |
Vamana Dhauti |
Vamana Dhauti once on day one followed by Shavasana rest and six days of yoga practice from day two to day seven |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Patients diagnosed with depressive disorder according to ICD11 or DSM V - TR
Patients with stable medications for the last one month |
|
ExclusionCriteria |
Details |
Any present diagnosis of gastric or duodenal ulcers, Hypertension, Cardiovascular disorders, Alcohol use associated with oesophageal varices, hernia, pregnant women, Co-morbidities like Diabetes associated with increased intra ocular pressure
Patients practising yoga, meditation or any mind body practice in last one month
Patients with risk of harm
Patients not willing to participate in the study |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Feasibility, tolerability of Vamana Dhauti
HRV changes at baseline, during and after the procedure (day 01) |
At baseline, after the procedure (day01) |
|
Secondary Outcome
|
Outcome |
TimePoints |
HDRS-17 scores |
Baseline and after seven days |
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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 1/ Phase 2 |
Date of First Enrollment (India)
|
10/07/2023 |
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
|
Patients will be recruited according to eligibility criteria and randomly divided into two groups. One group will be given Vamana Dhauti on day one followed by Shavasana rest whereas the other group will be given Shavasana rest. After this both will be given yoga practice (validated yoga protocol from previous studies) for six days (day two to day seven) At baseline HDRS-17 will be administered and HRV will be measured. On day one - HRV will be continuously measured during Vamana Dhauti and Shavasana. After seven days HRDS-17 will be again evaluated. |