| CTRI Number |
CTRI/2016/10/007386 [Registered on: 20/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
10/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on finding the effect food supplement on indigestion or upper abdominal pain |
Scientific Title of Study
Modification(s)
|
A double-blind, placebo controlled, randomized, clinical study to evaluate the efficacy and safety of test formulations |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CD-15-1406, Version 3.0 dated 18May2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paramesh Shamanna |
| Designation |
Principal Investigator |
| Affiliation |
Bangalore Diabetes Centre |
| Address |
Bangalore Diabetes Centre
No. 426, 4th cross,2nd block, Kalyan Nagar, Bangalore
Bangalore
KARNATAKA
560043
India |
| Phone |
9845010610 |
| Fax |
08025425396 |
| Email |
drparamesh2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Kadam |
| Designation |
Project Manager |
| Affiliation |
SEMLER RESEARCH CENTER |
| Address |
Semler Research Center Pvt Ltd,
75A, 15th Cross, I Phase J.P. Nagar, Bangalore
Bangalore
KARNATAKA
560 078
India |
| Phone |
919902205800 |
| Fax |
918026640683 |
| Email |
drkadam@semlerresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Bhaskar |
| Designation |
Project Manager |
| Affiliation |
SEMLER RESEARCH CENTER |
| Address |
Semler Research Center Pvt Ltd,
75A, 15th Cross, I Phase J.P. Nagar, Bangalore
Bangalore
KARNATAKA
560 078
India |
| Phone |
918042627276 |
| Fax |
918026640683 |
| Email |
vijay@semlerresearch.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC LIFE SCIENCES AND TECHNOLOGY CENTER |
| Address |
ITC Limited |
| Type of Sponsor |
Other [Fast Moving Consumer Goods] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ITC Ltd |
ITC Limited |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajanna |
Bangalore Diabetes Center |
No. 426 4th cross 2nd block Kalyan Nagar
Bangalore
KARNATAKA |
080-43479444
dr.rajanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Formulation without active ingredient |
| Comparator Agent |
Reference formulation |
Herbal extract |
| Intervention |
Test formulation |
Herbal extract |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
> Male or female dyspepsia subjects aged between 18 to 65 years of age at the time of screening visit.
> Subject clinically diagnosed with dyspepsia.
> Subject must be able to understand and complete questionnaires.
> Subject must be willing to or likely to comply with all study requirements.
> Subject willing to voluntarily sign the informed consent form.
> Subject meeting all the laboratory parameters set forth to qualify to enroll in the study. |
|
| ExclusionCriteria |
| Details |
> Use of Proton pump inhibitors (PPIs), H2 receptor antagonists and prokinetics.
> Subjects with Acute peptic ulcer, severe GERD and/or ulcer complications.
> Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors.
> Complications of gastroesophageal reflux disease which in the opinion of the Investigator may preclude trial participation.
> Severe or unstable systemic disease/ disorder.
> Intake of psychotropic medication, dyspepsia-inducing drugs, and anticholinergic agents.
> Diagnosis of any other clinically significant medical condition or serious gastrointestinal disorder which in opinion of investigator may jeopardize subject’s safety and preclude trial participation.
> Subjects with medical history of surgery of esophagus, stomach or duodenum.
> Abuse of drugs or alcohol confirmed by history.
> Pregnant or nursing female patients; Non-pregnant, non-lactating female patients of childbearing potential who are not using reliable method of contraception.
> Subjects with deteriorating health status at the time of enrollment.
> Autoimmune diseases, recent blood donation, immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection and hepatitis B)
> Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
> Subjects unwilling or unable to comply with the study procedures.
> History of allergy to any component of the study product. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes from baseline to visit 4 in dyspepsia in PP population. |
Day: 14 & 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of safety among the study population |
Day: 28 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/08/2016 |
| Date of Study Completion (India) |
13/01/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will be conducted as, double blind, placebo controlled, randomized, clinical study assessing safety and efficacy of two herbal test formulations and a standard herbal reference in controlling Dyspepsia in subjects with age range between 18 to 65 years (inclusive of both the ages). |