跳至主要内容
临床试验/CTRI/2025/04/084183
CTRI/2025/04/084183尚未招募不适用

Clinical utility of Prana Reset Time while imparting Yoga therapy for Common Mental Disorders

National Institute of Mental Health and Neurosciences1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
试验地点
1
主要终点
To assess and compare PRT in the healthy individuals and patients suffering from CMDs (anxiety, depression, obsessive compulsive disorder and schizophrenia) and to correlate PRT and the severity of common mental diseases

研究概览

简要总结

This study explores the clinical utility of Prana Reset Time (PRT) as an assessment tool while imparting yoga therapy for common mental disorders. A total of 240 participants will be recruited, including 120 healthy volunteers and 120 patients diagnosed with depression (30), OCD (30), schizophrenia (30), and anxiety disorders (30).

Study Design

Patients will be assessed for disease severity, while healthy individuals will be evaluated for general health. The study will include:

1. Nasal Dominance Assessment: Initially assessed subjectively, then confirmed using an acoustic rhinometer.

2. Prana Reset Time (PRT) Measurement: Participants will perform 15 sets of forward and backward bends, after which nasal dominance will be periodically reassessed until it returns to baseline. The time taken for restoration will be recorded. The entire set will be repeated.

  1. Yoga Intervention: n/3 patients will practice their respective validated yoga module for one week.

4. Safety and Medication Monitoring: Any adverse events will be documented, and medications prescribed and taken by both groups will be recorded throughout the study.

The study will evaluate PRT and its correlation with disease severity using standardized psychological and clinical assessment tools, including:

1. Perceived Stress Scale (PSS)

  1. Hamilton Anxiety Rating Scale (HAM-A)

  2. Hamilton Depression Scale (HAM-D)

4.Yale-Brown Obsessive-Compulsive Scale (YBOCS)

  1. Brief Psychiatry Rating Scale (BPRS)

  2. General Health Questionnaire (GHQ-12)

  3. Clinical Global Impression Scale – Severity of Illness (CGI-S)

By analysing these parameters, the study aims to determine whether PRT can serve as a reliable physiological marker for assessing the severity of mental health disorders. Findings from this research may contribute to integrating yoga-based assessments into clinical practice for better mental health management.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients with depression, anxiety, Obsessive Compulsive Disorder, Schizophrenia according to DSM5 and Healthy individuals with GHQ-12 score equal to or less than 12 of both genders who has given written informed consent.

排除标准

  • Patients not willing to give informed consent.
  • Abnormalities of the nasal cavity such as nasal septal deviation or nasal polyps.
  • Use of medication that could influence autonomic function (e.g., phenylpropanolamine as a common cold remedy).
  • Any upper respiratory tract infection that could cause nasal blockage
  • History of current medical illness that may significantly affect brain functions
  • Impaired general intellectual functioning (Mini-Mental Status Exam, MMSE below 24).
  • Past history of head injury or concomitant severe medical conditions.
  • Pregnant or post-partum subjects.

结局指标

主要结局

To assess and compare PRT in the healthy individuals and patients suffering from CMDs (anxiety, depression, obsessive compulsive disorder and schizophrenia) and to correlate PRT and the severity of common mental diseases

时间窗: Baseline

次要结局

  • To check the test retest reliability of PRT(Baseline)
  • To assess the correlation between subjective feeling and objective score of nasal dominance (as assessed by acoustic rhinometer)(Baseline)
  • To check the effect of 1 week practice of respective validated yoga modules on the prana reset time and clinical course(Baseline and 1 week of follow up)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Vibha S Gupta

National Institute of Mental Health and Neurosciences

研究点 (1)

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