Phase IV Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Product PETSAFFA in Subjects Suffering from Constipation

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/07/034540

Enrollment

120

Registered

2021-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Intervention1: Petsaffa: Oral administration of 1 teaspoon of PetSaffa granules with Luke warm water at night before bed Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. To determine the percentage of subjects with significant symptomatic reduction of constipation.Timepoint: Day 1 to Day 21	—

Secondary

Measure	Time frame
1.To assess the safety of IP Petsaffa Granules 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 3.To assess the incidence of AE reported or observed during study period Timepoint: Day 1 to day 21	—

Countries

India

Contacts

Public ContactMr Hasan Ali Ahmed

Divisa Herbal Care

vijaykimtata.vk@gmail.com9816333352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026