Vamana Dhauti as an add on treatment in Depression- a Pilot RCT

Phase 1/2

Not yet recruiting

Registration Number: CTRI/2023/07/054596

Lead Sponsor: Dr Aditi Garg

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

Patients diagnosed with depressive disorder according to ICD11 or DSM V.
TR Patients with stable medications for the last one month.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HRV changes at baseline, during and after the procedure (day 01)	At baseline, after the procedure (day01)
Feasibility, tolerability of Vamana Dhauti	At baseline, after the procedure (day01)

Secondary Outcome Measures

Name	Time	Method
HDRS-17 scores	Baseline and after seven days

Trial Locations

Locations (1): National Institute of Mental Health and Neurosciences
🇮🇳
Bangalore, KARNATAKA, India
National Institute of Mental Health and Neurosciences
🇮🇳Bangalore, KARNATAKA, India
Dr Aditi Garg
Principal investigator
8197724152
draditigargnaturo@gmail.com