Health Condition 1: null- Functional Dyspepsia
Conditions
Interventions
Intervention1: AGS/WEL01 Capsule: It contains Carica Papaya extract, Cyperus Rotundus extract, Ferula Foetida,Trachyspermum Ammi extract, Zingiber Officinale extract, Piper Longum, Piper Nigrum, Piper
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject with Functional Dyspepsia as defined by Rome III criteria having one or more of following symptoms: a). Bothersome postprandial fullness, b). Early satiation, epigastric pain, c). Epigastric burning with no evidence of structural disease. Subjects should have these symptoms for the last three months. 2. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects having a history of structural disease of Oesophagus, Stomach, duodenum. 2.Subjects having a history of previous abdominal surgery (in last 6 months). 3.Subjects having a history of organic deformity or malignancy of the GI tract. 4.Subjects with any active GI Bleeding, epigastric mass, peptic ulcer. 5.Pregnant or lactating women. 6.Chronic alcoholics and Habitual Tobacco chewers. 7.Subjects participating in any other Clinical study within 1 month prior to screening visit. 8.Subjects having known hypersensitivity to any ingredient of the study drug. 9.Any other condition due to which subjects are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of gastrointestinal symptoms on Gastrointestinal Symptom Rating Scale (GSRS) (Epigastric pain/upper abdominal pain, Bloating, loss of appetite, retrosternal discomfort Acidic eructation/ heartburn, Nausea, sickness, vomiting, abdominal cramps and early satietyTimepoint: Day-7, Day 0, Day 10, Day 20, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of postprandial fullness and flatulence 2. Assessment of frequency of Bowel movements 3. Assessment of requirement of rescue medications uses 4. Global assessment for overall change by subject and Investigator 5. Assessment of tolerability of AGS/WEL01 capsule 6. Assessment of changes in vitals. 7. Assessment of laboratory parameters Timepoint: Day-7, Day 0, Day 10, Day 20, Day 30 | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed