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CTRI Number  CTRI/2024/05/067532 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study of GutBio Capsule for the treatment of Irritable Bowel Syndrome and its symptoms. 
Scientific Title of Study   Prospective Open-label and Single-Center study for evaluation of efficacy and safety of Gutbio Capsule for Irritable Bowel Syndrome and its symptoms. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HHCRS-HH&HPL-004/22-23 (Version 3.0 dated 30/04/2024)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwin Porwal 
Designation  Principal Investigator 
Affiliation  Healing Hands Clinic Pvt Ltd. 
Address  Ground floor,millenium star extension adjacent to ruby hall entrance gate,balkrishna sakharam dhole patil Road,Pune Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax  -  
Email  drashwinporwal@healinghandsclinic.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashwin Porwal 
Designation  Principal Investigator 
Affiliation  Healing Hands Clinic Pvt Ltd. 
Address  Ground floor,millenium star extension adjacent to ruby hall entrance gate,balkrishna sakharam dhole patil Road,Pune Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax  -  
Email  drashwinporwal@healinghandsclinic.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Gajanan Bhagwat 
Designation  Manager Research & Development  
Affiliation  Research and development center,healing hands & herbs pvt.ltd. 
Address  Research and development center,healing hands & herbs Pvt.Ltd.101,mangalmurti complex C.T.S No.990 shukrawar peth,tilak road,Pune.

Pune
MAHARASHTRA
411002
India 
Phone  9404694494  
Fax    
Email  gajanan@healinghandsandherbs.org  
 
Source of Monetary or Material Support
Modification(s)  
Healing Hands and Herbs Pvt.Ltd. 101, Mangalmurti Complex, C.T.S. No. 990 Shukrawar Peth, Tilak Road, Pune- 411002. Maharashtra, India. 
 
Primary Sponsor  
Name  Healing Hands &Herbs Pvt Ltd. 
Address  101,Mangalmurti Complex,C.T.S No.990 Shukrawar Peth,Tilak Road,Pune 411002 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashwin Porwal  Healing Hands Clinic Pvt. Ltd.  Ground floor,millenium star extension adjacent to ruby hall entrance gate,balkrishna sakharam dhole patil Road,Pune.
Pune
MAHARASHTRA 		 9822347770

drashwinporwal@healinghandsclinic.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Healing hands IEC   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K582||Mixed irritable bowel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GutBio Capsule  1 Capsule after Breakfast and 1 capsule after Dinner with water or as prescribed by the physician.Total Duration is for 28 Days. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1.Patients aged 18 years & above.

2.Patient with a diagnosis of irritable bowel syndrome.

3.Patient or Parent or legal guardian willing to give a written informed consent or parental consent or assent form.

4.Able to or Willing to strictly adhere to the investigator’s prescription.

 
 
ExclusionCriteria 
Details  1.Individuals were excluded if they had taken any medications that might interfere with the action of the study medications prior to the start of the study or during the study.

2.Subjects with a history of coeliac disease, Inflammatory Bowel disease, bowel cancer, bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.

3.Subjects with a history of unexplained weight loss or rectal bleeding.

4.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.

5.Females who are not ready to use acceptable contraceptive methods during the course of study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate the improvement in the Irritable Bowel Syndrome- Symptom Severity Score, IBS-Adequate relief, Gastrointestinal symptom rating scale, Complete Spontaneous Bowel Movement and Stool consistency of GutBio capsule.   Upto Visit 5 (Day-43) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Evaluate the improvement in the Hamilton Anxiety Rating Scale, Hamilton Depression,Rating Scale and IBS-QoL Questionnaire.

2.Number of Participants with Treatment-Related Treatment-Emergent Adverse Events(TEAEs).

3.Safety evaluation of GutBio capsule.
Impact of GutBio capsule on overall quality of life of patients suffering from IBS.

4.Incidence of Adverse events.
 		 Upto Visit 5 (Day 43) 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 4 
Date of First Enrollment (India)   27/05/2024 
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="0"
Months="1"
Days="16" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2040?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The study is a Prospective, open-label, and single-center study for evaluation of efficacy and safety of             GutBio Capsule for irritable bowel syndrome and its symptoms”.

Eligible patients, both male and female above 18 years of age with symptomatic IBS, will be enrolled in the study. The decision to prescribe a GutBio Capsule will be made by the treating physician as     per clinical judgment. 

A detailed medical history will be obtained and a physical examination will be conducted for each patient by the study investigators. The total treatment duration is 4 weeks and patients will be followed up till the end of the study visit i.e Visit 5. Day 43.

At screening (Day -1 to Day 0), the potential patients will be identified by the site team, and written     informed consent (for patients aged 18 years and above will be procured before any study-related          procedures are undertaken. The assessment, as per the schedule of assessments , would be performed at screening and enrolment to determine eligibility.

A total of 100 subjects will be enrolled in the study. 100 subjects will receive GutBio Capsules twice daily as per physician discretion. The subject would be informed to visit the clinic on Day 8 (Visit 2), Day 15 (Visit 3), Day 29 (Visit 4), and Day 43 (visit 5). Safety assessment will be done            throughout the duration of the study.

 
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