Yogic Gut Aeration Techniques to Inhibit Helicobacter Pylori Induced Acid Peptic Diseases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- 1)Inhibition of Helicobacter pylori bacteria.
研究概览
简要总结
Helicobacter pylori bacteria is the cause of most of the Gastro-Intestinal Tract infections (Mandeville et al., 2009). Fifty percent of the human population is suffering from H. pylori infection (Hooi et al., 2017) and more than 20 million Indians are estimated to suffer from the same (Thirmurthi & Graham, 2012), which has potential to cause Gastro Intestinal Diseases such as gastritis, peptic ulcer, gastric cancer, duodenal ulcer and gastric mucosal associated lymphoid-tissue such as lymphoma, anemia, vitamin B12 deficiency, gastric atrophy, primary gastric B-cell lymphoma etcetera (Malfertheener, Chan, & Coll, 2009).
In order to inhibit H. pylori, most of the patients are consuming Proton Pump Inhibitors (PPIs) such as Omeprazole, Lansoprazol, and Pantoprazole etcetera to control their symptoms related to Acid Peptic Diseases (APDs). It is common observation that a substantial number of patients keep taking PPIs for several months to years which are known to cause neuropathy, ischemic heart disease, dementia and acute kidney injury (Desbuissons, Deray & Mercadal, 2017). Over use of PPIs is not only the reason for adverse side effects but also has become a big economic burden for concerned authorities and stakeholders due to its exponentially increasing cost (Savarino, Dulbecco, Bortoli, Ottonello, & Savarino, 2016) (which is around 1355$ ) as calculated by Dache, Steward,& Graber (2007) on October 2007 and aforementioned side effects. This creates a big challenge for prevention and treatment of H. pylori in conventional medical system and warrants the need of innovative researches to discuss efficacy of complementary and Alternative Medicine (CAM) to inhibit it. In the CAM, air ingestion through YGATs, maneuvering it through the GIT and releasing it as flatus is described in the ancient yogic text (Gheranda Samhita, 1:15, 16, 17, Sarswati,1997) as a gut cleansing process. H. pylori are micro-aerophilic organism which grows best in absence of oxygen and presence of a little carbon-dioxide (Malshe, 2016). Accordingly, various anti- H. pylori regimens are being used clinically with proven effectiveness Aeration of the gut has been proposed as an effective way to inhibit H. pylori and other microaerophilic/anaerobic microorganisms (Malshe, 2010). This warrants a Randomized Controlled Trial (RCT) entitled “Yogic Gut Aeration Techniques to Inhibit Helicobacter Pylori Induced Acid Peptic Diseasesâ€.
To drink air, retain into pyloric region and subsequently manoeuvre it into gut to release as a flatus can be performed by two yogic ways: 1) Doing inverted postures immediately after ingesting air through kaki/bhujangi mudra to retain it into pyloric region followed its maneuvering into lower gut; and 2) Using pierced straw to drink air followed by drinking of water and then go for postural manipulation (inverted postures) as explained by Dr Malshe (2010).
Objectives
The specific objectives of the research are to assess the efficacy of YGAT on
-
H. pylori count/infection
-
Stress level
-
Quality of life
-
Frequency and doses of medication/s intake of patients afflicted with APDs.
Method
78 participants will be screened from employees and patient populations at Patanjali Yoga Peeth and other organizations using Gastrointestinal symptom rating scale, their symptoms if any would be recorded. Those who will score more than 27 will be included for the study. A short clinical examination will be made at the beginning for selected subjects that includes stool antigen test to check the presence of bacteria, to measure quality of life the quetionnaire named “Quality of life for reflux and dyspepsia†will be used and for measuring stress “stress indicator questionnaire†will be used before and after the intervention. out of 78 participants 39 will be randomly allocated for each experimental and control group. experimental group will be taught the mentioned yogic techniques of drinking air. All candidates will be supervised for 3 months and their symptoms will be reviewed once again after intervention. Those who were taking PPIs regularly will be specially inquired for their need to take PPIs in-between the intervention and a special note will be made about medicinal intake. Success of the taught technique will be evaluated by questioning about gas passage, auscultation over the stomach area and plain x- ray of abdomen if needed. Control group will continue the allopathic medicine. After 3 months again stool antigen test will be taken to check the presence of bacteria for both the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •pylori induced APDs(GERD, hyperacidity,1st stage ulcer.Subjects with positive H.Pylori test and score > 27 in the GSRS(Gastrointestinal Symptom Rating Scale).
排除标准
- •Patients with: tonsillectomy, recent abdominal surgery, and pregnancy hypertension,Severe spinal problems or other chronic illnesses.
结局指标
主要结局
1)Inhibition of Helicobacter pylori bacteria.
时间窗: 3 months
2)Improvement in overall GIT health.
时间窗: 3 months
3)Reduce frequency of medicinal intake.
时间窗: 3 months
次要结局
- 1.)Improvement in overall GIT health and quality of life.(2.)Therapeutic application of YGATs to prevent and moderate APDs in the other population.)
- 1)Improve Quality of life.(2)Reduce level of stress.)
