| CTRI Number |
CTRI/2018/05/013993 [Registered on: 21/05/2018] Trial Registered Prospectively |
| Last Modified On: |
19/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to establish the safety and efficacy of a natural formulation -Asdamarin in dyspepsia patients |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, parallel group study to evaluate the Safety and Efficacy of Asdamarin in subjects with non- ulcer functional Dyspepsia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Khanna |
| Designation |
Principal Investigator |
| Affiliation |
Aman Hospital and Research Centre |
| Address |
Room No:1,Department of general medicine,Aman Hospital and Research Centre Pvt Ltd. 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT
390021
India |
| Phone |
|
| Fax |
|
| Email |
amankhanna11974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
No 9 , Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
No 9 , Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs (P) Ltd,No. 10, 33rd Main, 16th Cross,JP Nagar, 6th Phase,
Bangalore – 560 078
|
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Private Limited |
| Address |
No. 10, 33rd Main, 16th Cross,JP Nagar, 6th Phase, Bangalore – 560 078 |
| Type of Sponsor |
Other [Manufactureres of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Aman Khanna |
Aman Hospital and Research Centre |
Room No: 1, Department of General medicine, 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT |
990402122
amankhanna11974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aman Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients diagnosed with non - ulcer functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asdamarin |
Asdamrin 250mg (400mg Capsules) 2 times per day for 7 days |
| Comparator Agent |
Placebo |
400 mg of maltodextrin 2 times per day for 07 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Fulfilling Rome III diagnostic criteria for functional dyspepsia
2. Must be willing and able to give informed consent and comply with the study procedures
3. Female subjects who are non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator
|
|
| ExclusionCriteria |
| Details |
1 History of peptic ulcer, gastro oesophageal reflux disease, gastro intestinal surgery or any other clinically significant gastro intestinal disease, gastrointestinal bleeding, mechanical obstruction, perforation, gastrointestinal cancer.
2 Subjects who have taken antibiotics or any other drugs in last 2 weeks with primary site of action in the gastro intestinal tract
3 History of psychiatric illness
4 History of congestive heart failure or uncontrolled hypertension
5 Subjects with abnormal haematological or biochemical parameters
6 Pregnant or lactating women or those planning for conception
7 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Gastro Intestinal Symptom Rating Scale, Glasgow Dyspepsia Severity Score ,Nepean Dyspepsia Index from baseline to end of the study |
Day 0, Day 07 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Hematological and Biochemical Safety Parameters |
Day 0, Day 07 |
| Incidence of Adverse Events |
Day 07 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
is a randomized, double blind, placebo controlled, parallel group, multicenter
study. The main purpose of the study is to prove the efficacy of Asdamarin as a
health supplement in subjects suffering from dyspepsia. Subjects diagnosed with
dyspepsia meeting all inclusion and no exclusion criteria will sign a written
informed consent and will be enrolled in the study.Safety and and efficacy will be established by comparing the study parameter values from baseline to end of the study. |