Dizester a Herbal formulation for dyspepsia
- Conditions
- Health Condition 1: K30- Functional dyspepsia
- Registration Number
- CTRI/2021/09/036266
- Lead Sponsor
- Dr Willmar Schwabe India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary End point <br/ ><br>Improvement in symptoms on Reflux Disease Questionnaire <br/ ><br>Timepoint: Days 0 and 7 and 14
- Secondary Outcome Measures
Name Time Method �Improvement in The Short Form Leeds Dyspepsia Questionnaire <br/ ><br>�Improvement GERD Health Related Quality of Life Questionnaire <br/ ><br>�Improvement in visual analogue scale for pain <br/ ><br>�Improvement in Investigators Assessment Symptomatic <br/ ><br>�Changes in liver and renal function <br/ ><br>�Changes in hemogram hemoglobin, total leukocyte count and differential countTimepoint: Days 0 and 7 and 14