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

An Open, Prospective, Comparative Study to Assess the Efficacy and Safety of Pudin Hara Pearls & Liquid in the Management of Indigestion

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009227

Enrollment

Registered

2017-08-02

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

None listed

Interventions

Intervention1: Pudin Hara Liquid: Each 1ml (20 drops approx) of Pudin Hara Liquid comprises Pudinah Satva (Mentha piperata, Aerial part, Ol. ) - 0.0337 ml along with excepients, preservatives and colo

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Overall safety of the subjectsTimepoint: Daily for 5 Days	—

Countries

India

Contacts

Public ContactDr Sasibhushan Vedula

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results