A clinical trial to study the effect of Pranayamas as an additional treatment for managing patients with Bipolar I disorder

Not Applicable

• Conditions: Health Condition 1: F31- Bipolar disorder

• Registration Number: CTRI/2023/05/052726
• Lead Sponsor: DST SATYAM (Science and Technology for Yoga and Meditation)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Inclusion criteria for cases:

Patients diagnosed with Bipolar I Disorder as per ICD-10 DCR (International Classification of Diseases 10th edition â?? Diagnostic Criteria for Research) presently in euthymic state defined by current Young Mania Rating Scale (YMRS) score of 7 or less and Hamilton Depression Rating Scale (HDRS) of 7 or less, on stable doses of mood stabilisers and/or antipsychotics for the last 6 weeks. (Dose: Diazepam less than or equal to10 mg, Clonazepam less than or equal to 0.5mg or Lorazepam less than or equal to 2mg)

Inclusion criteria for control:

Age and gender-matched healthy subjects will be recruited from within the institutional campus from among the healthcare workers and other staff of the hospital.

Exclusion Criteria

Exclusion criteria for both cases and controls:

Patients with comorbid alcohol, tobacco, cannabis, or other drug dependence as per ICD-10 DCR criteria, patients with current active infections such as tuberculosis (on 8 weeks active phase treatment) or COVID-19 (within the last 3 weeks), comorbid autoimmune diseases, Pregnancy or lactation, acute unstable medical illnesses which may prevent the active participation of the study participant in the various study procedures, comorbid poorly controlled chronic medical illnesses such as hypertension (BP more than180 mmHg systolic or more than 110 mmHg diastolic) or diabetes mellitus (FBS more than 180 mg% or PPBS more than 300 mg% or Random BS more than 300 mg%) or poorly controlled hyper- or hypothyroidism within the last one month period, pre-existing hepatic and renal disease, connective tissue diseases, and malignancies, and individuals who are already practising some form of structured exercises or yoga on a regular basis will also be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sympathovagal balance (LF:HF ratio)Timepoint: Change in LF:HF ratio from 0 weeks (baseline) to the end of 6 and 12 weeks