Role of GastriCare in Digestive wellbeing

Phase 2

Completed

Conditions: Subjects who have clinical symptoms of dyspepsia, upper abdominal pain, heart burn, bloating, indigestion, flatulence, abdominal distension, belching and fullness after meal

Brief Summary: Results of the present study showed that in subjects treated with Triphala, significant reduction in the symptoms of constipation was observed. Triphala also displayed significant improvement in stool consistency and frequency score. In subjects treated with placebo, there was minimal improvement but not clinically significant. There were no significant adverse reactions, either reported or observed, during the entire study period and overall compliance to the treatment was excellent. The beneficial clinical efficacy of Triphala in the management of constipation could be due to the synergistic actions of its ingredients. Therefore, it may be concluded that Triphala is clinically effective and safe in the management of constipation.

Recruitment & Eligibility

Inclusion Criteria

1 Subjects of both sexes in the age group of 18.
60 years, with gastric problems. 2 Subjects who have clinical symptoms of dyspepsia, upper abdominal pain, heart burn, bloating, indigestion, flatulence, abdominal distension, belching and fullness after meal. 3 Subjects willing to give written informed consent. 4 Subjects who have not participated in similar kind of study in last 4 weeks.

Exclusion Criteria

1 Subjects with established hypertension, renal, hepatic or cardiac failure 2 Endocrine disorders 3 Use of prescription medication to treat gastric problems 4 Pregnant & lactating women.
5 Not willing to sign informed consent form.

Primary Outcome Measures

Name	Time	Method
Clinical improvement in the overall health as assessed by clinical examination of signs and symptoms such as epigastric discomfort, heartburn, Nausea, vomiting, belching, flatulence, fullness in the stomach, abdominal distension and the points mentioned in questionnaire	baseline, 2nd week and 4th week

Secondary Outcome Measures

Name	Time	Method
Compliance of the subject to the drug treatment and the adverse effects will be noted	baseline and 4th week

Locations (1): Sapthagiri Institute of Medical Sciences and Research Centre
🇮🇳
Bangalore, KARNATAKA, India
Sapthagiri Institute of Medical Sciences and Research Centre
🇮🇳Bangalore, KARNATAKA, India
Dr Bindumathi PL MBBS MD General Medicine
Principal investigator
080-28393392
drbinduraghu@gmail.com