Evaluating the Efficacy and Safety of product Petsaffa Tablets in patients suffering from Constipation, gas and acidity

A Single Centric, Open-Label, Non-Randomized Phase IV Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Product PETSAFFA Tablets in Subjects Suffering from Constipation, Gas and Acidity.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/03/051058

Enrollment

120

Registered

2023-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age Between 18 and 80 2.Subjects suffering from Constipation, Gas and Acidity 3.Subjects willing to sign ICF 4.Subjects willing to refrain taking any other similar medication during the study period.

Exclusion criteria

Exclusion criteria: 1.Pregnant, breast-feeding subjects undergone any surgery and else take taken part in any clinical trial. 2.Participation in any other clinical study (device or drug) within 30 days prior to Screening. 3.Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, hepatic, renal disease, congenital or any other disorder 4.Subject with abnormal lab values detected at the time of screening shall be excluded. 5.A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the investigational product. 6.Pre-existing systemic disease necessitating long-term medications. 7.Genetic and endocrinal disorder. 8.Not willing to sign the ICF or give the consent.

Design outcomes

Primary

Measure	Time frame
1.To determine the percentage of subject with significant symptomatic reduction of constipation. 2.To assess the percentage of subjects with significant symptomatic reduction of gas and acidity. Timepoint: Day 0, Day 14	—

Secondary

Measure	Time frame
1.To assess the safety of IP Petsaffa tablets 2.To assess the frequency of bowel movement 3.To Assess the stool consistency measured by Bristol stool from scale & constipation questionnairesâ?? score 4.To assess the incidence of AE reported or observed during study period Timepoint: 14 days	—

Countries

India

Contacts

Public ContactMr Hasan Ali Ahmed

Divisa Herbals Pvt. Ltd.

vishu.gupta@divisa.in08042115562

Outcome results