| CTRI Number |
CTRI/2019/02/017407 [Registered on: 04/02/2019] Trial Registered Prospectively |
| Last Modified On: |
06/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
A Double-Blind, Randomized, parallel (adaptive) clinical study to evaluate the efficacy and safety of 3 different types of formulations on bowel function. |
Scientific Title of Study
Modification(s)
|
A Double-Blind, Randomized, parallel (adaptive) clinical study to evaluate the efficacy and safety of 3 different types of formulations on bowel function. |
| Trial Acronym |
Bowel Function Study. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
MD, Medicine |
| Affiliation |
Meenakshi Hospital |
| Address |
Meenakshi Hospital, B-12, Ananad Vihar, Kaushambi, Gaziabad UP- 201010
Meenakshi Hospital, B-12, Ananad Vihar, Kaushambi, Gaziabad UP- 201010
Ghaziabad
UTTAR PRADESH
Dr Ajay Kumar Gupta
India |
| Phone |
9871134389 |
| Fax |
|
| Email |
drajaykumargupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
MD, Medicine |
| Affiliation |
Meenakshi Hospital |
| Address |
Meenakshi Hospital, B-12, Ananad Vihar, Kaushambi, Gaziabad UP- 201010
Meenakshi Hospital, B-12, Ananad Vihar, Kaushambi, Gaziabad UP- 201010
Ghaziabad
UTTAR PRADESH
Dr Ajay Kumar Gupta
India |
| Phone |
9871134389 |
| Fax |
|
| Email |
drajaykumargupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
MD, Medicine |
| Affiliation |
Meenakshi Hospital |
| Address |
Meenakshi Hospital, B-12, Ananad Vihar, Kaushambi, Gaziabad UP- 201010
Meenakshi Hospital, B-12, Ananad Vihar, Kaushambi, Gaziabad UP- 201010
Ghaziabad
UTTAR PRADESH
Dr Ajay Kumar Gupta
India |
| Phone |
9871134389 |
| Fax |
|
| Email |
drajaykumargupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| IR Innovate Research Pvt. Ltd |
|
|
Primary Sponsor
|
| Name |
ITC Life Science and Technology center |
| Address |
Penya Industrial Area, No-3, First Main, First Phase, Bangalore, Karnataka |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Ajay Kumar Gupta |
Dr. Ajay Kumar Gupta |
Meenakshi Hospital, B-12, Ananad Vihar, Kaushambi, Gaziabad UP- 201010
Ghaziabad
UTTAR PRADESH |
9871134389
drajaykumargupta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Society for Research Welfare Independent Ethics Committee |
Approved |
| Society For Research Welfare Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Constipated |
|
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Elderly with digestive complaints (Bowel Function)} - Male or Female Age 55-65 years. (E.g. Documented History of Chronic Constipation, IBS, Diarrhea, Stomach pain etc. (For Group –A )
2. Constipated Subjects (complaints of hard and lumpy stools) – Male or Non-pregnant Female Age 18- 50 years ( For Group – B )
3. Healthy subjects (as defined by medical history & physical examination)-male or non-pregnant female – Age 18- 50 years (For Group C )
4. Rome-III diagnostic criteria prescribed for IBS. (For Group – B) (Annexure I)
5.Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with changes in frequency of stool.
(Group-B)
6.Relief of pain or discomfort with defecation. (Group – B)
7. Capability to provide written informed consent (For all Groups) |
|
| ExclusionCriteria |
| Details |
1.The subject has a serious, unstable medical condition,such as lung disease,uncontrolled blood pressure,uncontrolled thyroid function,a physical or medical disability or an advanced medical condition.
2.The subject had previous significant gastric or intestinal surgery except appendectomy and gall bladder surgery.
3.IBS sub type other than IBS associated with Constipation.
4.Diarrhea more than 3 bowel movements per day.
5.Antibiotic use within 4 weeks of randomization.
6.Pregnant or lactating women.
7.Subjects on the ongoing therapies with the drugs known to effect gut motility e.g. Laxatives, prokinetics, etc.
8.Subject with eating disorder.
9.History of alcohol, drug, or medication abuse.
10.Participation in another study with any investigational product (IP) within 3 months of randomization.
11.Subject with any condition that might interfere with the conduct of the study as per Investigator’s opinion.
12.Known allergies to any substance in the study product, including lactose intolerance and galactosemia. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Assessment of Bowel function , stool frequency and consistency, PH, fecal questioner |
Group A Day 1, Day 14, Day 60, Day 75
Group B&C Day 1, Day 14, Day 28, Day 43 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Bowel function-stool frequency and consistency
• Microflora composition (Lactobacilli, Bifidobacteria)
• Fecal calprotectin
• Abdominal symptoms
• The Quality of Life Scale (QOLS)
• POMS Based assessment
• Physiological assessment for health/ clinical markers(BMI, calf circumference and mid arm circumference
|
Group A Day 1, Day 14, Day 60, Day 75
Group B&C Day 1, Day 14, Day 28, Day 43 |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="229" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2019 |
| Date of Study Completion (India) |
10/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Will be published on request |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Once recruitment will be completed then study will be published with approval of sponsor. |