Impact of Abdominal Pack on Gastric Myoelectrical Activity and Serum Gastrin Level in Functional Dyspepsia: A Three-Arm Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Dr Yadhushree P V
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- 1. Cutaneous Electrogastrography
Overview
Brief Summary
The Rome IV consensus defines functional dyspepsia (FD) as “the presence of symptoms thought to originate in the gastroduodenal region, in the absence of any organic, systemic, or metabolic disease that is likely to explain the symptoms”. The Rome IV criteria define dyspepsia as any combination of four symptoms: early satiety, postprandial fullness, epigastric pain, and epigastric burning that occurs at least three days a week for the past three months, with an onset that occurs at least six months beforehand and is severe enough to interfere with daily activities. Based on this illness’s primary symptoms and potential causes, the Rome IV diagnostic criteria classify FD into epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), and overlapped EPS-PDS subtype. Heartburn, nausea, bloating, and belching are among the other uncomfortable symptoms that many FD patients encounter. Although the exact prevalence of dyspepsia in India is unknown, some research suggests that 7.6-49% of Indians are affected. While there is no correlation between the disease and a higher death rate, the patient’s quality of life is negatively impacted by both physical and psychological discomfort. Psychometric assessments showing feelings of anxiety, depression, and somatization yield higher scores for patients with functional dyspepsia. The hot and cold abdominal pack has been of great assistance in many cases, the results have been so positive and satisfactory that it is nearly unparalleled as a hydriatic procedure in the certainty with which it yields the desired results. This treatment has shown to be particularly effective in both sensory and motor disturbances of the stomach. Ice packs or compresses over the stomach area can enhance the production of hydrochloric acid by the stomach, making it a highly beneficial treatment for hypopepsia. Applying hot fomentations across the stomach for an hour or two after eating can significantly enhance the amount of hydrochloric acid secreted by the peptic glands. In hyperpepsia, the hot douche/pack over the stomach and spine opposite reduces the amount of HCl secreted. In hyperpepsia, the hot douche over the stomach and spine opposite minimizes the amount of HCl secreted. This study intends to evaluate the impact of cold and hot abdominal packs on serum gastrin levels and gastric myoelectrical activity in functional dyspepsia and correlate the hormonal and neural mechanism of dyspepsia before and after the intervention with the dyspepsia symptom score.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Individuals who fulfil the functional dyspepsia Rome IV criteria.
- •Subjects who can fast for 8hrs.
- •Subjects who willingly consent to take part in the study procedure and who provide written informed consent authorizing the collection of their personal data.
Exclusion Criteria
- •Participants who, within the past year, had an esophagogastroduodenoscopy to confirm a diagnosis of structural gastrointestinal disorder.
- •Participants displaying overt indications of IBS, individuals exhibiting warning signs, such as dysphagia, black or tar stools or weight loss, anatomical abnormalities, paralysis, clotting disorders, leukopenia or seizure disorders.
- •Participants who have undergone gastrointestinal surgery within the last six months.
- •Pregnant or nursing women.
- •Subjects who are intolerant to cold and heat.
- •Patients who are taking medications that may have an impact on the gastrointestinal tract.
- •Participants with a history of drug or alcohol addiction.
Outcomes
Primary Outcomes
1. Cutaneous Electrogastrography
Time Frame: Pre, Post
2. Serum gastrin test
Time Frame: Pre, Post
Secondary Outcomes
- EuroQoL 5-dimension (EQ 5D) questionnaire
- The Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ)(Pre, post)
Investigators
Dr Yadhushree P V
SDM College of Naturopathy and Yogic Sciences