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CTRI Number  CTRI/2024/02/063038 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Nutraceutical 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   A clinical study of GutBio Capsule for the treatment of chronic constipation. 
Scientific Title of Study   "A prospective, open label, single contre & Placcbo controlled study for evaluation of efficacy & safety of Gutbio Plus capsule for chronic constipation & its symptoms." 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
HHCRS-HH&HPL-002/22-23;version-1;dated-05/09/2023   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwin Porwal 
Designation  Principal Investigator 
Affiliation  Healing Hands Clinic 
Address  Ground Floor, Millenium Star Extension Adjacent to Ruby Hall Entrance Gate, Balkrishna Sakharam Dhole Patil Rd, 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 
Address  Ground Floor, Millenium Star Extension Adjacent to Ruby Hall Entrance Gate, Balkrishna Sakharam Dhole Patil Rd, 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  R&D Manager 
Affiliation  R&D Centre, Healing Hands & Herbs Pvt. Ltd. 
Address  101, Mangalmurti Complex, C.T.S. No. 990 Shukrawar Peth, Tilak Road, Pune- 411002. Maharashtra, India.

Pune
MAHARASHTRA
411002
India 
Phone  9404694494  
Fax    
Email  gajanan@healinghandsandherbs.org  
 
Source of Monetary or Material Support  
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. Maharashtra, India. 
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  Ground Floor, Millenium Star Extension Adjacent to Ruby Hall Entrance Gate, Balkrishna Sakharam Dhole Patil Rd, Pune, Maharashtra 411001
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: K590||Constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GutBio Plus Capsule  1 Capsule after Breakfast and 1 Capsule after dinner with water for 29 days. 
Comparator Agent  Placebo Capsule (Glucose Capsule)  1 Capsule after Breakfast and 1 Capsule after dinner with water for 29 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients aged above 18 years of age.
2. Patient with a diagnosis of chronic constipation
3. Patient or Parents or legal guardian willing to give a written informed consent or parental consent or assent form.
4. Able to 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. 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 
Overall Complete Spontaneous Bowel Movement Response.  Upto fifth visit. 
 
Secondary Outcome  
Outcome  TimePoints 
1. evaluate the Gastrointestinal Quality of Life Index of Patients suffering from Functional constipation, abdominal pain and bloating.
2. Number of Participants with Treatment-Related Treatment-Emergent Adverse Events.
3. Incidence of adverse events.  		 Upto fifth visit. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   04/03/2024 
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="15" 
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 study is a Prospective, open-label, single-center and placebo-controlled for the evaluation of the efficacy and Safety of the GutBio Plus Capsule for chronic constipation and its symptoms.
  Eligible patients both male and female Aboe18 years of age with symptomatic Functional constipation, Abdominal Pain and bloating will be enrolled in the study. The treating physician will make the decision to prescribe the GutBio Plus Capsule as per clinical judgment.  
  Medical history will be obtained and a physical examination will be conducted for each patient by the study investigators. The treatment duration is 29 Days and the Post-treatment period is 14 Days. Patients will be followed up till the end of the study (Day 43).
  At screening (Day 1 or 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. 
  A total of 60 subjects will be enrolled in the study. 45 subjects will receive GutBio Plus Capsules twice daily and 15 subjects will receive Placebo capsules twice daily or as per physician discretion. The subject would be informed to visit the clinic after 07 Days (Visit 2), 15 Days (Visit 3), 29 Days (Visit 4) and 43 Days (Visit 5) for Post-treatment follow-up. Safety assessment will be done throughout the study duration. At clinic visits spirometry, medical examination will be performed, AEs will be recorded, vital signs will be evaluated and changes in medication will be recorded, and compliance will be checked with study medication. Patients will be instructed to take their daily dose of study medication on the days of the clinic visits, as these doses will be administered at the clinic under the supervision of study personnel.
 
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