| CTRI Number |
CTRI/2024/12/077988 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Non pharmacological intervention (yoga )] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of yoga among psychiatric patients taking benzodiazepines and z drugs |
|
Scientific Title of Study
|
Assessing the impact of yoga on quality of life and sleep among patients deprescribed of benzodiazepines and related z drugs. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vasan BB |
| Designation |
Pharm D |
| Affiliation |
M.S. Ramaiah University of applied science |
| Address |
Room No:120,Dept. of Pharmacy Practice, Faculty of Pharmacy,
M.S. Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Mathikere, Bangalore-560054, karnataka, India.
Bangalore
KARNATAKA
560054
India |
| Phone |
6360161352 |
| Fax |
|
| Email |
vasanbbvasanbb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Maheswari |
| Designation |
professor ,Department of pharmacy practice ,FPH,MSRUAS. |
| Affiliation |
M.S. Ramaiah University of applied science |
| Address |
Room No: 426,Dept. of Pharmacy Practice, Faculty of Pharmacy,
M.S. Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Mathikere, Bangalore-560054, karnataka, India.
Bangalore
KARNATAKA
560054
India |
| Phone |
9620451165 |
| Fax |
|
| Email |
maheswari.pp.ph@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Maheswari |
| Designation |
Professor ,Department of pharmacy practice ,FPH,MSRUAS. |
| Affiliation |
M.S. Ramaiah University of applied science |
| Address |
Room No:426,Dept. of Pharmacy Practice, Faculty of Pharmacy,
M.S. Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Mathikere, Bangalore-560054, karnataka, India.
Bangalore
KARNATAKA
560054
India |
| Phone |
9620451165 |
| Fax |
|
| Email |
maheswari.pp.ph@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Dept. of Pharmacy Practice, Faculty of Pharmacy,
M.S. Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Mathikere, Bangalore-560054, karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Vasan BB |
| Address |
Dept. of Pharmacy Practice, Faculty of Pharmacy,
M.S. Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Mathikere, Bangalore-560054, karnataka, India. |
| 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 |
| Vasan BB |
M.S. Ramaiah Medical College Hospital |
No-41A, Department of Psychiatry, M.S. Ramaiah Medical College Hospital, NEW BEL Road, MSR Nagar, Mathikere, Bangalore-560054, karnataka, India.
Bangalore
KARNATAKA |
6360161352
vasanbbvasanbb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.S. Ramaiah University of Applied Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, (2) ICD-10 Condition: F419||Anxiety disorder, unspecified, (3) ICD-10 Condition: F316||Bipolar disorder, current episodemixed, (4) ICD-10 Condition: F411||Generalized anxiety disorder, (5) ICD-10 Condition: F172||Nicotine dependence, (6) ICD-10 Condition: F428||Other obsessive-compulsive disorder, (7) ICD-10 Condition: F200||Paranoid schizophrenia, (8) ICD-10 Condition: F250||Schizoaffective disorder, bipolartype, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No yoga and No benzodiazipine deprescribing |
The comparator group include patients does not parctice yoga nor prescribed with benzodiazepine |
| Intervention |
Yoga and Benzodiazepine deprescribing |
1. The intervention include yoga practice like shukshma vyayama followed by surya namaskar, asanas like ardhakatichakrasana, shashankasana, paschimothasana, vakrasana and pranayama. Yoga will be practiced 4 times a week for 3 months.
2. Deprescribing will be carried out according to benzodiazepine and z drugs, deprescribing algorithm by conducting comprehensive medical and medication history. Also shared decision making for facilitation of deprescribing will be done by involving patients and psychiatrist in discussions regarding potential risks, benefits, withdrawal plans, symptoms and duration.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients ≥ 18 years age
Patients consenting to provide necessary responses
Ability to sit or lie comfortably for more than 30 minutes at a time.
Psychiatric patients who have been prescribed with benzodiazepines and z – drugs will be included in first 3 groups.
Psychiatric patients who are not prescribed with benzodiazepines and z- drugs will be included in group 4 (control group).
Group 1 – Patients deprescribed of benzodiazepines after 4 weeks according to benzodiazepines and z- drugs deprescribing algorithm and practicing yoga.
Group 2 – Patients continuing with benzodiazepines even after 4 weeks and practicing yoga.
Group 3 - Patients continuing with benzodiazepines even after 4 weeks and not practicing yoga.
Group 4 - Patients neither taking benzodiazepines nor practicing yoga .
|
|
| ExclusionCriteria |
| Details |
Patients with unavoidable lifestyle sleep disruption.
Patients who have been practicing yoga for last 6 months.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the impact of yoga on Quality of life among psychiatric patients.
|
3 months from the start of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of yoga on Quality of Sleep among psychiatric patients |
3 months from the start of intervention |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/12/2024 |
| Date of Study Completion (India) |
15/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This prospective interventional study aimed to assess the impact of yoga on quality of life (QoL) and quality of sleep (QoS) among psychiatric patients undergoing deprescription of benzodiazepines (BZDs) and Z-drugs. The study was conducted in the Department of Psychiatry at Ramaiah Medical College Hospital, Bengaluru. A total of 400 patients were recruited and divided into four groups: - Group 1: BZD deprescribed after 4 weeks and practicing yoga
- Group 2: BZD continued after 4 weeks and practicing yoga
- Group 3: BZD continued after 4 weeks and not practicing yoga
- Group 4: No BZD and not practicing yoga
Yoga intervention (asana, pranayama, and relaxation) was provided 5 times/week for 3 months. BZD deprescribing followed a structured algorithm and shared decision-making approach. QoL was assessed using the WHOQOL-BREF and QoS using the Pittsburgh Sleep Quality Index (PSQI) at baseline and at 3 months. Group 1 showed the most significant improvements in both QoL and QoS. Group 2 also showed moderate improvement. Minimal benefit was observed in Group 3, and Group 4 showed a decline. The study concludes that yoga, in combination with BZD deprescribing, significantly enhances QoL and sleep quality in psychiatric patients. These findings support the integration of structured non-pharmacological interventions like yoga into deprescribing programs. |