| CTRI Number |
CTRI/2018/04/013249 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of GastriCare in Digestive wellbeing |
|
Scientific Title of Study
|
A Clinical study to evaluate the safety and efficacy of GastriCare in individuals with Functional Dyspepsia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/56/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bindumathi PL MBBS MD |
| Designation |
Professor and HOD |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre
Door No 15
Chikkasandra Hesaragatta Main Road
Bangalore
Bangalore
KARNATAKA
560 090
India |
| Phone |
080-28393392 |
| Fax |
080-22188737 |
| Email |
drbinduraghu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bindumathi PL MBBS MD |
| Designation |
Professor and HOD |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Door No 15
Chikkasandra Hesaragatta Main Road
Bangalore
Bangalore
KARNATAKA
560 090
India |
| Phone |
080-28393392 |
| Fax |
080-22188737 |
| Email |
drbinduraghu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bindumathi PL MBBS MD |
| Designation |
Professor and HOD |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Door No 15
Chikkasandra Hesaragatta Main Road
Bangalore
Bangalore
KARNATAKA
560 090
India |
| Phone |
080-28393392 |
| Fax |
080-22188737 |
| Email |
drbinduraghu@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company, Makali, Tumkur Road |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company Research and Development, Makali, Bangalore – 562 162 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bindumathi PL MBBS MD General Medicine |
Sapthagiri Institute of Medical Sciences and Research Centre |
Door No 15
Chikkasandra
Hesaragatta Main Road
Bangalore-560 090
Bangalore
KARNATAKA |
080-28393392
080-22188737
drbinduraghu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Sapthagiri Institute of Medical Sciences and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Subjects who have clinical symptoms of dyspepsia, upper abdominal pain, heart burn, bloating, indigestion, flatulence, abdominal distension, belching and fullness after meal, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GastriCare A |
1 capsule of GastriCare A thrice daily |
| Comparator Agent |
GastriCare B |
1 capsule of GastriCare B thrice daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Compliance of the subject to the drug treatment and the adverse effects will be noted |
baseline and 4th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/09/2016 |
| Date of Study Completion (India) |
09/11/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|