Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Jawarish Bisbabsa: 5gm(semisolid) orally to be taken taken twice daily with water 1 hour before meals for 8 weeks
Control Intervention1: Tab Rabeprazole 20mg: 1 tablet of 20 mg orally w
Sponsors
State Takmeel Ut Tib College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of all gender between the age group of 18 60 years. 2. Patient meets Rome IV criteria for Functional Dyspepsia with one or both subtypes: a. Postprandial Distress Syndrome (PDS): bothersome postprandial fullness and/or early satiation more than 3 day/week. b. Epigastric Pain Syndrome (EPS): epigastric pain and/or burning more than 1 day/week. c. Symptom duration more than 3 months, with symptom onset more than 6 months before screening 3. Patients with NDI total score more than 31 (moderate) and SF-LDQ total score more than 05 (moderate). 4. Heartburn or Regurgitation not predominant and not requiring continuous PPI (GERD Overlap). 5. Patient who will give consent and are able to do follow up. 6. Patients who have undergone upper GI endoscopy within the last 3 months and found to have no organic pathology.
Exclusion criteria
Exclusion criteria: 1. Patient below 18 and above 60 years. 2. Patients with history of Unintentional weight loss (more than 5 percent in 6 months), overt GI bleeding, iron-deficiency anemia, progressive dysphagia/odynophagia, persistent vomiting, palpable abdominal mass or lymphadenopathy, family history of upper GI cancer in a first-degree relative less than 50 years. 3. Patients with documented esophageal or gastric disease (esophagitis, Barrett s esophagus, predominant reflux, GERD, peptic ulcer, celiac disease, inflammatory bowel disease, pancreatic or biliary disease, gastric/duodenal surgery, gastroparesis). 4. Patients with severe systemic illnesses. 5. Patients with history of recent initiation/change of drugs affecting upper GI function within 4 weeks: PPIs, H2 blockers, prokinetics, antispasmodics, tricyclics, SSRIs/SNRIs, mirtazapine, benzodiazepines 6. Patients with history of chronic NSAID/aspirin use (more than 3 doses/week). 7. Patients with history of severe uncontrolled psychiatric disorder (e.g., acute major depression with suicidality), eating disorders, cognitive impairment precluding adherence. 8. Pregnant, planning pregnancy, or breastfeeding women of childbearing potential. 9. Patients with history of Alcohol or substance misuse that may interfere with participation. 10. Patients with known hypersensitivity or contraindication to the investigational product or rescue medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in GSRS, SF-LDQ and PAGI-SYMTimepoint: Baseline,15th day,30th day, 45th day and 60th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in NDITimepoint: Baseline & 60th day | — |
Countries
India
Contacts
Public ContactDr Mohammad Shahid
State Takmeel-Ut-Tib College & Hospital
Outcome results
None listed