EVALUATING THE EFFICACY OF YOGA AS AN ADJUNCT TO CONVENTIONAL TREATMENT ON SYMPTOMATIC RELIEF AND MENTAL WELL-BEING IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Gerd Symptoms using GERDQ questionnaire
研究概览
简要总结
Title of the Study: Evaluating the Efficacy of Yoga as an Adjunct to Conventional Treatment on Symptomatic Relief and Mental Well-Being in Patients with Gastroesophageal Reflux Disease (GERD)
Type of Study: Randomized Controlled Trial (Parallel Group Design)
Study Design and Randomization: This is a 12-week, randomized, parallel controlled study with two groups. A total of 120 participants will be enrolled, with 60 patients in each group. Randomization will be carried out using a computer-generated block randomization list. Allocation concealment will be maintained through the snoSEAL (sealed envelope) method.
Study Groups:
Group A (Intervention Group): Yoga-based intervention (specific yoga protocol) + Conventional medical treatment for GERD.
Group B (Control Group): Conventional medical treatment alone.
Sample Size: 120 participants (60 in each group).
Study Setting: The study will be conducted in the Department of Gastroenterology, Himalayan Institute of Medical Sciences (HIMS), Swami Rama Himalayan University, Dehradun, Uttarakhand, India.
Follow-up and Assessments:
Baseline and post-intervention assessments (after 12 weeks) will be done using standardized tools such as GERD-Q, GERD-HRQL, and Perceived Stress Scale (PSS).
Intervention group will follow a structured yoga protocol (35 minutes/day, 6 days/week, for 12 weeks) including diaphragmatic breathing, Nadi Shodhan, Bhramari, systematic relaxation, and meditation.
Primary Outcome Measures:
Reduction in GERD symptoms (measured by GERD-Q)
Secondary Outcome Measures:
-
Reduction in stress levels (PSS).
-
Improvement in quality of life (GERD-HRQL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals diagnosed with erosive GERD 2.Subjects between the age group of 18 between 70
- •Both literate and illiterate
- •participants who consume alcohol occasionally.
排除标准
- •Patients diagnosed with non-erosive reflux disease
- •Subjects who have recently undergone any thoracic and abdominal surgery
- •Patients diagnosed with Barretts esophagus
- •Patient with a diagnosis of liver cirrhosis
- •Individuals with current or past or current diagnoses of any form of malignancy
- •An individual consuming alcohol cigarettes and other drugs
- •An individual having medication that triggers GRED like calcium channel blocker beta blockers etc
- •Patients with large hiatal hernia Grade 3 and Grade 4.
结局指标
主要结局
Gerd Symptoms using GERDQ questionnaire
时间窗: Baseline and final assessment after 12 weeks
次要结局
- 1 Stress by PSS-10(2 Quality of life by GERD-HRQL)
研究者
Ankit Semwal
School of Yoga Science, Swami Rama Himalayan University, Jolly grant, Dehradun, India