Clinical study on Ayucid Capsules in Acidity patients
- Conditions
- Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
- Registration Number
- CTRI/2018/01/011260
- Lead Sponsor
- Welex Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 63
1.Subjects having history of heartburn equal to or more than 12 months and less than 5 years.
2.Subjects having GERD Questionnaire score equal to or more than 8.
3.Subjects with current episodes of moderate to severe heartburn on at least 4 occasions in the last 7 days prior to screening.
4.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
1.Subjects who are known to have gastric ulcer, duodenal ulcer, Gastric Ca etc.
2.Subjects who undergone abdominal surgeries.
3.Subjects with an anticipated need for concomitant medication with anticholinergics, promotility agents, prostaglandin analogs, sucralfate, nonsteroidal anti-inflammatory drugs (NSAIDs), or salicylates other than low-dose aspirin
4.Chronic alcoholics and Habitual Tobacco chewers.
5.Known cases of Severe or Chronic hepatic or renal disease.
6. Known subject of any active malignancy.
7. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
8. Known hypersensitivity to any of the ingredients used in study drug.
9. Pregnant and Lactating females
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of complete resolution of heartburn in two groupsTimepoint: Day -3, Day 0, Day 7, Day 14, Day 21, Day 28
- Secondary Outcome Measures
Name Time Method 1 Assessment of other symptoms of GERD <br/ ><br>2 Assessment of requirement of rescue medication <br/ ><br>3 Assessment of quality of life on GERD HRQL <br/ ><br>4 Assessment of other digestion related symptoms <br/ ><br>5 Assessment of safety based on clinical adverse events and laboratory test results <br/ ><br>6 Global assessment for overall improvement by subject and investigator at the end of study treatment <br/ ><br>Timepoint: Day -3, Day 0, Day 7, Day 14, Day 21, Day 28