Efficacy Of Ayurveda Treatment Protocol Compared To Vonoprazan In Patients With Functional Dyspepsia (Amlapitta) A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
Functional Dyspepsia is common type of Functional Gastro- Intestinal Disorder having high prevalence of 20-40 % and impact on quality of life.
The current management strategies in modern medicine primarily are using of proton pump inhibitors, antacids, H2 blockers and prokinetics which may offer only temporary benefit and are often associated with adverse effects or recurrence upon discontinuation.
Amlapitta, as described in Ayurveda, is a prevalent gastrointestinal disorder characterized by symptoms such as Avipaka (indigestion), Tikta-Amla Udgara (sour or bitter belching), Hrit-Kantha Daha (burning sensation in chest and throat), and Gaurava (heaviness). These symptoms show a close resemblance to the modern clinical entity of Functional Dyspepsia (FD), a chronic gastrointestinal disorder defined by upper abdominal discomfort or pain without any identifiable organic cause. Inspite of Vast Clinical experience from various Ayurveda Practitioners, treatment of Amlapitta based on dosha predominance requires scientific evidence.
Scientifically evaluate the efficacy and safety of selected Ayurvedic treatment(s) in the management of Functional Dyspepsia. Provide a cost-effective, side-effect-free, and sustainable treatment alternative to conventional therapies.
Generate evidence-based data that could support the integration of Ayurvedic approaches in mainstream gastrointestinal care. Contribute towards the global recognition and acceptance of Ayurveda in managing psychosomatic and lifestyle-related digestive disorders.
Very few RCTs comparing Ayurveda treatments in line with modern conventional drugs.Hence the Ayurveda treatment protocol which is efficacious, safe, affordable and alternative to conventional system of medicine is the needed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Age between 18 and 60 Years.
- •2.Sex : Both sexes.
- •3.Patients with signs and symptoms of Functional Dyspepsia.
- •4.Patients with signs and symptoms of Amlapitta.
- •5.Patients who are willing to give written informed consent.
- •6.Those patients who are on existing FD treatment will be asked to undergo a 7 days wash out period.
- •After this interval, they may be included in our study.
Exclusion Criteria
- •1.Patients who are regularly consuming NSAIDs, low dose aspirin will be excluded.
- •2.Patients having History of bleeding disorders.
- •3.Known case of CA stomach and TB.
- •4.History(within 6months) or diagnosed case of H.pylori infection.
- •5.Patients with history of uncontrolled HTN/DM and other major systemic illness.
- •7.Those high risk patients who are having upper Gastrointenstinal pathology which require Upper GI Endoscopy for evaluation.
- •8.Patients suffering or having history of peptic ulcer, gastric or esophageal malignant disease or patient undergone gastrectomy.
Investigators
Dr Zanzad Vrushali Bhagwan
KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi