Health Condition 1: null- Patients diagnosed with non - ulcer functional dyspepsia
Conditions
Interventions
Intervention1: Asdamarin: Asdamrin 250mg (400mg Capsules) 2 times per day for 7 days
Control Intervention1: Placebo: 400 mg of maltodextrin 2 times per day for 07 days
Sponsors
Vidya Herbs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1 History 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. 2 Subjects who have taken antibiotics or any other drugs in last 2 weeks with primary site of action in the gastro intestinal tract 3 History of psychiatric illness 4 History of congestive heart failure or uncontrolled hypertension 5 Subjects with abnormal haematological or biochemical parameters 6 Pregnant or lactating women or those planning for conception 7 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in Hematological and Biochemical Safety ParametersTimepoint: Day 0, Day 07;Incidence of Adverse EventsTimepoint: Day 07 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Private Limited
Outcome results
None listed