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CTRI Number  CTRI/2023/09/058081 [Registered on: 27/09/2023] Trial Registered Prospectively
Last Modified On: 23/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Clinical Trial to Evaluate safety & Efficacy of Kiwibiotic Vs Psyllium Husk for Functional Constipation, Abdominal Pain and Bloating. 
Scientific Title of Study   Prospective, Interventional, Comparative, Single Center, Cross-Over Study for Evaluation of Efficacy of Kiwibiotic Vs Psyllium Husk for Functional Constipation, Abdominal Pain and Bloating. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HHCRS-HH&HPL-002/23-24;Version 2.0;14/08/23  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAshwin 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 Rd, Pune, Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax    
Email  drashwinporwal@healinghandsclinic.co.in  
 
Details of Contact Person
Scientific Query  
Name  DrAshwin 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 Rd, Pune, Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax    
Email  drashwinporwal@healinghandsclinic.co.in  
 
Details of Contact Person
Public Query  
Name  DrAshwin 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 Rd, Pune, Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax    
Email  drashwinporwal@healinghandsclinic.co.in  
 
Source of Monetary or Material Support  
Healing Hands and Herbs Mangalmurti complex,Hirabaug Chowk Tilak road Pune,411002 
 
Primary Sponsor  
Name  Healing Hands &Herbs Pvt Ltd. 
Address  110,Mangal Murti Complex,Lokmanya Bal Gangadhar Tilak Rd, Dadawadi, Shukrawar Peth, Pune, Maharashtra 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 
DrAshwin 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. Ayurveda Condition: VIBANDHA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Psyllium Husk, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.82(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Kiwibiotic, Reference: NA, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1.Patients aged ≥18 years of age.

2.Patient with a diagnosis of Functional constipation, Abdominal Pain and bloating.

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

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

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

2.Patient having any existing conditions that might compromise their safety or participation in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• The primary endpoint compared the change in the symptoms of functional constipation, Abdominal pain & bloating.  • upto 5th visit i.e.Day 49. 
 
Secondary Outcome  
Outcome  TimePoints 
• Secondary endpoints evaluate the Gastrointestinal Quality of Life Index of Patients suffering from Functional constipation, abdominal pain & bloating [Time Frame: up to 5th Visit]
• Overall treatment evaluation (OTE) scores by physician. [Time Frame: up to 5th Visit]
• Incidence of adverse events.
 		 time frame upto visit 5  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  		 13/10/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="19" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Functional constipation (FC) is a clinically common functional gastrointestinal disorder that affects both children and adults all over the world. FC, also known as chronic idiopathic constipation, is a type of chronic constipation caused by dysfunction or disturbance in the physiological functions of defecation for a variety of reasons other than irritable bowel syndrome (IBS), and without organic lesions or structural abnormalities that cause defecation difficulty.Existing research has shown that sedentary lifestyles, dietary habits and types such as low vegetable and fruit intake (low dietary fibre), insufficient water intake, and low levels of education all contribute to an increased prevalence of FC.  Laxatives are commonly used as first-line pharmacological therapy as they are cheap and readily available over the counter. 

Kiwifruit has various uses in Gastrointestinal disorders. The components found in kiwifruit have been shown to increase fecal bulking and softness and enable better lubrication, assisting the propulsion of content along the colon. It is thought that the unique combination of soluble and insoluble fibres, polyphenols and actinidin, present in kiwifruit, confers gastrointestinal benefits, improvements in laxation and reduction of abdominal discomfort, both in individuals with either constipation-predominant irritable bowel syndrome (IBS-C) and in normal healthy people suffering from constipation without reported side effects. The putative mechanism of kiwifruit on the maintenance of normal GI function has recently been reviewed. 
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