| CTRI Number |
CTRI/2024/10/074762 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To observe the impact of lifestyle-based interventions (delivered digitally) on symptom relief and quality of life improvements for Indian IBS(irritable Bowel Syndrome) patients. |
|
Scientific Title of Study
|
Digital Health Interventions for IBS- A longitudinal analysis of patient outcomes using an App (DailyBloomâ„¢ IBS) based approach |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kalapala |
| Designation |
Senior Consultant Gastroenterologist & Director (Endoscopy) |
| Affiliation |
AIG Hospitals (A unit of Asian Institute of Gastroenterology) |
| Address |
AIG Hospitals (A unit of Asian Institute of Gastroenterology), No 136, Plot No: 2/3/4/5 Survey, 136/1, Mindspace Road, Gachibowli, Hyderabad, Pin code:500032, Telangana, India
Hyderabad
TELANGANA
500032
India |
| Phone |
9989211034 |
| Fax |
|
| Email |
drrakesh.kalapala@aighospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar Katare |
| Designation |
Medical Cluster Head- CR |
| Affiliation |
Dr. Reddy’s Laboratories Limited |
| Address |
Dr. Reddy’s Laboratories Limited 8-2-337, Road No. 3, Banjara
Hills, Hyderabad TELANGANA
500034 India
Hyderabad
TELANGANA
500034
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Katare |
| Designation |
Medical Cluster Head- CR |
| Affiliation |
Dr. Reddy’s Laboratories Limited |
| Address |
Dr. Reddy’s Laboratories Limited 8-2-337, Road No. 3, Banjara
Hills, Hyderabad TELANGANA
500034 India
Hyderabad
TELANGANA
500034
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddy’s Laboratories Limited,
8-2-337, Road No.3
Banjara Hills
Hyderabad–500034,
Telangana, India |
|
|
Primary Sponsor
|
| Name |
Dr. Reddy’s Laboratories Limited |
| Address |
8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana
– 500034, India |
| 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 Rakesh Kalapala |
AIG Hospitals (a unit of Asian Institute of Gastroenterology) |
AIG Hospitals (a unit of Asian Institute of Gastroenterology), No 136, Plot No: 2/3/4/5 Survey, 136/1, Mindspace Road, Gachibowli, Hyderabad, Pin code: 500032, Telangana, India
Hyderabad
TELANGANA |
9989211034
drrakesh.kalapala@aighospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIG Hospitals (a unit of Asian Institute of Gastroenterology) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients from eighteen years of age to fifty years of age of either gender
2. Diagnosed with IBS (Using ROME III, ROME IV or Maning’s Criteria based on the treating physician discretion) 3. Ongoing medical treatment as per standard of care (SoC) under supervision of Gastroenterologist 4. Comfortable for using smartphone for management and agreeing to follow study related procedures 5. Subscribed to program -based management (Daily BloomTM IBS) pertaining to dietary, psychological and physical interventions 6. Provides written informed consent for participation in the study |
|
| ExclusionCriteria |
| Details |
1. Patients with co-existing medically significant conditions affecting the participation as mentioned below: Patients with IBS who have alarm signs (haematochezia, melena, unintentional weight loss, older age of onset of symptoms, family history of IBD, colon cancer, or other significant GI disease. [IBS ACG Guideline]). 2. Patients with untreated/uncontrolled coexisting diseases (e.g. intestinal parasites, malignancy, psychiatric disorders, diabetes mellitus cardiovascular, pulmonary, hepatic, or renal disorder). 3. Patients with (irritable bowel syndrome on inflammatory bowel disease) IBD-IBS 4. In the opinion of the treating physician any other condition that may interfere the study participation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness
1. To evaluate the change from the baseline in IBS-SSS score at each of the study specific time points 2. To evaluate the change from the baseline in IBS specific QoL score at each of the study specific time points 3. Hospital Anxiety and Depression Scale from baseline to week 14
Safety
1. Safety Monitoring
Average number of flare-ups of the IBS symptoms during the study period |
Baseline, Week 5, 11 & 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness
Adherence will be based on the following 1.Nutritionists:
No. of calls vs planned
Duration of calls vs planned
Food logging or planned
2.Psychological
No of calls vs planned
Duration of calls or planned
Thought worksheets filled or number of flare ups reported
3.Videos
No of videos watched or planned
Total number of mins viewed or planned |
Baseline, Week 5, 11 & 14 |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
24/10/2024 |
| 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="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The consented subjects would be assigned to medical treatment by a Gastroenterologist and all 3 additional interventions through DailyBloomTM IBS product as recommended by the Gastroenterologist based on individual IBS patient need, of dietary plan based on FODMAP principles, mental wellness - Gut Directed Psychotherapy (Cognitive Behavioural Therapy), Physical wellness - Exercises, Yoga, Relaxation techniques digitally delivered through DailyBloomâ„¢ IBS [program, call and chat support]. Phase 1: Onboarding Phase (1 week), Phase 2: Elimination phase (4 weeks), Phase 3: Reintroduction phase (6 weeks), Phase 4: Sustenance phase (3 weeks) Medical History as per the eligibility criteria |