Pudin Hara Pearls & Pudin Hara Liquid evaluted for its efficacy & safety gor indication in Indigestio

Phase 2

Completed

• Registration Number: CTRI/2017/08/009227
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2006-06-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 79

Inclusion Criteria

Subjects suffering from functional dyspepsia i.e. indigestion and its related signs and symptoms such as fullness, bloating, nausea, gassy discomfort, loss of appetite, spasm and pain in the chest or abdomen for at least on two occasions in the preceding week and were having normal hepatic and renal functions (LFT & RFT)

Exclusion Criteria

Subjects with persistent dyspepsia, vomiting, severe epigastric pain unintentional weight loss, iron deficiency anemia, gastro-intestinal bleeding, dysphasia, odynophagia, previous gastric surgery, epigastric mass, suspicious barium meal, peptic ulcer, and NSAID use. Organic deformity or malignancy of the GI tract, significant systemic and psychological condition (s) which may hamper the study proceedings, conditions requiring immediate surgical intervention, known hypersensitivity to study product or ingredient (s), concomitant medications known to adversely interact with study products or their ingredients, alcohol or drug abuse, pregnancy, lactation and females planning to conceive in near future

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The current study evaluated the efficacy and safety of Pudin Hara Pearls and Pudin Hara Liquid in subjects with functional dyspepsia in terms of improvement in symptoms.Timepoint: Daily for 5 days

Secondary Outcome Measures

Name	Time	Method
Overall safety of the subjectsTimepoint: Daily for 5 Days