Yogic gut aeration for managing Helicobacter pylori induced Dyspepsia A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- changes in Inhibit H. pylori infection and reduce dyspeptic symptoms, addressing psychological and improving, QOL.
研究概览
简要总结
50% of the global human population and over 20 million Indians are suffering from helicobacter pylori (H.pylori) infection.it may result in gastrointestinal disorder -dyspepsia different gastric ulcers, anemia, vitamin B12 deficiency, gastric atrophy, primary gastric B-cell lymphoma, etc. H.pylori is a microaerophilic bacterium found on the gastric epithelium, thriving in 5-15% Oxygen and inhabited when exposed to oxygen level equal to or higher than the atmospheric levels. Yogic gut Aeration techniques (YGAT). as described in Gherand Samhita, involve air ingestion, maneuvering into the gut and releasing as flatus. YGAT is proposed as a gut cleansing and detoxification method, potentially inhibiting H. Pylori and other microaerophilic/anaerobic in the gut and mitigating dyspepsia.
The study proposes a one-month RCT to assess the effects of YGAT on H.pylori inhibition, dyspepsia its symptoms, quality of life (QoL), and psychological comorbidities (depression , anxiety and stress), carbon-uera breath test (UBT), Gastrointestinal Symptoms Rating Scale (GSRS), Depression, Anxiety, Stress, Scale( DASS-21) and Quality of Life in Reflux and Dyspepsia (QOLRAD) will be used as measurement tools. A total of 132 participants will be enrolled and allocated to two groups: the experimental group and the control group in the study.
The data will be analyzed by using the Shapiro-Wilk test and split analysis of variance for between groups, within- group, and interactive effects, along with Bonferroni -adjusted post hoc analysis.
Primary outcomes include improvement in the C-UBT test and Dyspepsia after one month of intervention. Secondary outcomes include the improvement in dyspeptic symptoms, QoL, and psychological comorbidities (depression, anxiety and stress) after one month of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender with H.
- •pylori induced dyspeptic clinical symptoms, aged 15-60 years and having willingness to yoga practice, and no other chronic illness/es, pregnancy, recent surgery and addictive behaviors will be included.
排除标准
- •1.Patients with upper gastrointestinal bleeding gastrointestinal malignancy, documented H.pylori eradication and other life-threatening conditions.
- •2.Dyspeptic patients with recent abdominal surgery, tonsillectomy, hypertension, pregnancy, severe spinal problems and other chronic illness.
- •3.Dyspeptic patients taking PPIs, NSAIDs or corticosteroids and H2 receptor antagonists or antibiotics with in 4 weeks preceding the intervention.
结局指标
主要结局
changes in Inhibit H. pylori infection and reduce dyspeptic symptoms, addressing psychological and improving, QOL.
时间窗: At baseline (T0) and at 3 months (T1)
次要结局
未报告次要终点