A clinical study to establish the safety and efficacy of a natural formulation -Asdamarin in dyspepsia patients
- Conditions
- Health Condition 1: null- Patients diagnosed with non - ulcer functional dyspepsia
- Registration Number
- CTRI/2018/05/013993
- Lead Sponsor
- Vidya Herbs Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Fulfilling Rome III diagnostic criteria for functional dyspepsia
2.Must be willing and able to give informed consent and comply with the study procedures
3.Female subjects who are non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator
1History of peptic ulcer, gastro oesophageal reflux disease, gastro intestinal surgery or any other clinically significant gastro intestinal disease, gastrointestinal bleeding, mechanical obstruction, perforation, gastrointestinal cancer.
2Subjects who have taken antibiotics or any other drugs in last 2 weeks with primary site of action in the gastro intestinal tract
3History of psychiatric illness
4History of congestive heart failure or uncontrolled hypertension
5Subjects with abnormal haematological or biochemical parameters
6Pregnant or lactating women or those planning for conception
7Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Gastro Intestinal Symptom Rating Scale, Glasgow Dyspepsia Severity Score ,Nepean Dyspepsia Index from baseline to end of the studyTimepoint: Day 0, Day 07
- Secondary Outcome Measures
Name Time Method Change in Hematological and Biochemical Safety ParametersTimepoint: Day 0, Day 07;Incidence of Adverse EventsTimepoint: Day 07
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