| CTRI Number |
CTRI/2022/07/044075 [Registered on: 18/07/2022] Trial Registered Prospectively |
| Last Modified On: |
15/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the effect of ASFP001/21 and SMXP001/22 on improvement in quality of life in healthy volunteers with mild to moderate functional dyspepsia symptoms. |
|
Scientific Title of Study
|
A randomized, double blinded, placebo controlled comparative study to evaluate the effect of ASFP001/21 and SMXP001/22 on improvement in quality of life in healthy volunteers with mild to moderate functional dyspepsia symptoms. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena RM |
| Designation |
Principal Investigator |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore
Bangalore
KARNATAKA
560060
India |
| Phone |
9741073960 |
| Fax |
|
| Email |
drveenarm.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
Department of Clinical Research #9,Mythri Legacy, 202 1st Floor,Chelekere Kalyan Nagar (PO), Bangalore
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 |
Department of Clinical Research #9,Mythri Legacy, 202 1st Floor,Chelekere Kalyan Nagar (PO), Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Natural Ingredients Pvt. Ltd,Malaidamthuruthu P.O, Ernakulam, Kerala, India. |
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Pvt Ltd |
| Address |
Malaidamthuruthu P.O, Ernakulam, Kerala, India. |
| Type of Sponsor |
Other [Manufacturer 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 Veena RM |
BGS Global Institute of Medical Sciences |
Department of Pharmacology, 3rd Floor, #67, BGS Health and Education City, Uttarahalli road, Kengeri
Bangalore
KARNATAKA |
9482164779
drveenarm.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild to moderate functional dyspepsia symptoms |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASFP001/21 |
Oral administration of two doses of ASFP001/21 250mg capsules everyday for 14 days |
| Comparator Agent |
Placebo |
Oral administration of two doses of Placebo 250mg capsules everyday for 14 days |
| Intervention |
SMXP001/22 |
Oral administration of two doses of SMXP001/22 250mg capsules everyday for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Fulfilling Rome IV diagnostic criteria for functional dyspepsia
2.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
3. Must be willing and able to give informed consent and comply with the study procedures.
|
|
| 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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life in mild to moderate functional dyspepsia symptoms |
Day 0, Day 2, Day 3, Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Gastro Intestinal Symptoms |
Day 0, Day 2, Day 3, Day 7 and Day 14 |
| Change in cognitive functions |
Day 0 and Day 14 |
| Change in gut microbiota |
Day 0 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
18/07/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"Nill" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a double-blind, randomized (1:1:1), placebo-controlled, comparative clinical study. Subjects having mild to moderate functional dyspepsia symptoms [ meeting all inclusion and no exclusion criteria] after signing a written informed consent will be enrolled in the study. The subject will undergo laboratory assessment, cognitive function tests, biomarker assessments, and other questionnaire-based assessments at different time points .The study is planned to be conducted in 5 visits over a period of 14 days. |