A clinical study to find The safety and efficacy of Asafin in patients suffering from dyspepsia
- Conditions
- Health Condition 1: null- Subjects with Non Ulcer functional Dyspepsia
- Registration Number
- CTRI/2018/01/011149
- Lead Sponsor
- Akay Flavours and Aromatics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1.Age 25-55 Years ( Both Inclusive)
2.Male and Female Subjects
3.Fulfilling Rome III Diagnostic Criteria for Functional Dyspepsia
4.Subject Willing To give written Informed consent
1.History of Peptic ulcer, Gastro oesophageal Reflux Disease, Gastro Intestinal surgery or any other clinically significant gastro intestinal disease.
2.Psychiatric illness
3.Pregnant or Lactating women.
4.History of Congestive Heart Failure or uncontrolled hypertension
5.Subjects with abnormal hematological or Biochemical Parameters
6.Subjects who have taken antibiotics or any other drugs in last 2 weeks whose primary site of action is in the GIT-.
7.Any condition that in Opinion of the Investigator, does not justify the Subjectsâ?? participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in <br/ ><br>Gastrointestinal Symptom Rating Scale (GSRS), Glasgow Dyspepsia Severity Score <br/ ><br>(GDSS), and Nepean Dyspepsia Index (NDI) from BaselineTimepoint: Screening <br/ ><br>Day 0 <br/ ><br>Day 30
- Secondary Outcome Measures
Name Time Method Comparative assessment of Safety parametersTimepoint: Day 0, Day 30