Phase IV Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Product PETSAFFA in Subjects Suffering from Constipatio
Phase 4
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2021/07/034540
- Lead Sponsor
- Divisa Herbal Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age Between 18 and 80
2.Subjects suffering from Constipation
3.Subjects willing to sign ICF with mention health issues
Exclusion Criteria
Pregnant, Breastfeeding subjects undergone any surgery and else take taken part in any clinical Trial
2.Not willing to Sign the ICF or give the consent
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To determine the percentage of subjects with significant symptomatic reduction of constipation.Timepoint: Day 1 to Day 21
- Secondary Outcome Measures
Name Time Method 1.To assess the safety of IP Petsaffa Granules <br/ ><br>2.To assess the percentage of subjects with significant symptomatic reduction of gas and acidity post intervention assessed through Investigator Assessment Scale and Subject Assessment Questionnaires <br/ ><br>3.To assess the incidence of AE reported or observed during study period <br/ ><br> <br/ ><br>Timepoint: Day 1 to day 21