Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Dizester Herbal liquid: Five to ten ml to be taken orally two to three times a day
Control Intervention1: Matched placebo liquid: Five to ten ml to be taken orally two to three times a
Sponsors
Dr Willmar Schwabe India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients in the age group between 18 to 65 years of either sex. 2. Patients able to provide informed consent. 3. Subject fulfilling the Rome IV criteria for functional dyspepsia which includes one or more of the following � Bothersome postprandial fullness � Bothersome early satiation � Bothersome epigastric pain � Bothersome epigastric burning and � No evidence of structural diseases (including the upper endoscopy) that is likely to explain the symptoms � Must fulfill criteria for Postprandial Distress Syndrome and or Epigastric Pain Syndrome. � Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis. 4. Patients will included on the basis of signs and symptoms of Non ulcer dyspepsia, epigastric pain, burning sensation over epigastrium/ retrosternal region, sour, bitter eructation, nausea, vomiting, indigestion and abdominal distension.
Exclusion criteria
Exclusion criteria: 1. Patients on Proton pump inhibitors 2. Pregnant or lactating women or with infants less than 1 year 3. Any preexisting condition or contraindications like CAD, abnormal creatinine levels, liver dysfunction. 4. Patients with alarm features like unintentional weight loss, recurrent vomiting, dysphagia, hemetemesis, melena, fever, jaundice, or anemia 5. Any kind of organic lesion such as peptic ulcer, tumor of any kind, stricture, or structural deformity. 6. A previous endoscopic diagnosis of erosive gastroesophagitis or Barretts esophagus 7. Subject with known history of gastric bleeding, intestinal obstruction or perforation, and previous gastrointestinal surgery. 8. Subjects with major systemic illness including cardiac disease, liver disease, kidney disease, diabetes, hypertension, psychoneuroendocrinal disorders 9. Smoking or drug addicts or with psychiatric illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary End point Improvement in symptoms on Reflux Disease Questionnaire Timepoint: Days 0 and 7 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Improvement in The Short Form Leeds Dyspepsia Questionnaire ââ?¬Â¢ Improvement GERD Health Related Quality of Life Questionnaire ââ?¬Â¢ Improvement in visual analogue scale for pain ââ?¬Â¢ Improvement in Investigators Assessment Symptomatic ââ?¬Â¢ Changes in liver and renal function ââ?¬Â¢ Changes in hemogram hemoglobin, total leukocyte count and differential countTimepoint: Days 0 and 7 and 14 | — |
Countries
India
Contacts
Public ContactDr Manas Kumar Panigrahi
AIIMS Bhubaneswar
Outcome results
None listed