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CTRI Number  CTRI/2026/01/100291 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 16/07/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Study to Find Out if Triphala Capsules Are Safe and Helpful for People Who Have Constipation-Related Bowel Problems 
Scientific Title of Study   An Open-Label, Single-Arm, Single-Centre Clinical Study to Evaluate the Safety and Efficacy of Triphala Capsules in Participants with Constipation Predominant Irritable Bowel Syndrome. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CTSRS/2530 Version No. 2.0 Dated 08 Jun 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjunath U 
Designation  Principal Investigator 
Affiliation  Currex Hospital Bangalore 
Address  Ground floor, OPD 5, No 55, 56,Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli, KS Halli

Bangalore
KARNATAKA
560049
India 
Phone  6364898825  
Fax    
Email  drmanju1910@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Sathyavathi L M 
Designation  HOD - Clinical Operations 
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit, No. 1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block

Bangalore
KARNATAKA
560069
India 
Phone  9739001749  
Fax    
Email  satyalm@samahitha.com  
 
Details of Contact Person
Public Query  
Name  Ms Mamatha B Gokavi 
Designation  Project Manager 
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit, No. 1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block

Bangalore
KARNATAKA
560069
India 
Phone  06364898825  
Fax    
Email  mamatha@samahitha.com  
 
Source of Monetary or Material Support
Modification(s)  
Apex Laboratories Private Limited 
 
Primary Sponsor
Modification(s)  
Name  Apex Laboratories Private Limited 
Address  Apex Laboratories Private Limited B-59, SIPCOT Industrial Park, Irungattukottai, Kancheepuram District,Chennai 602117, Tamil Nadu, 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 Manjunath U  Currex Hospital   Ground Floor, OPD 5, No.55-56, Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli, KS Halli
Bangalore
KARNATAKA 		 06364898825

drmanju1910@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K581||Irritable bowel syndrome with constipation. Ayurveda Condition: GRAHANIDOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphala , Reference: Amla, Haritaki, Bibhitaki, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants of either sex with age between 18 years and 65 years.
2. Diagnosis of IBS as per Rome IV criteria with following symptoms for more than 3 months.
Abdominal discomfort such as mild pain, cramping, bloating
Altered bowel habit indicated by frequent constipation
Functional dyspepsia
3. Able and willing to give written informed consent.
4. Women of childbearing potential must be willing to practice an acceptable method of contraception throughout the study.
5. Willingness and ability to comply with all study procedures, visit schedules, and follow-up assessments. 
 
ExclusionCriteria 
Details  1. Pregnant, breastfeeding, or planning pregnancy during the study.
2. Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction.
3. On antibiotics or laxatives within the preceding 6 weeks.
4. Presence of inflammatory bowel disease, acute GI tract infection.
5. Presence of fever, abdominal mass, signs of bowel obstruction.
6. History of colon cancer or diverticulitis.
7. Participated in another clinical drug trial within 3 months before recruitment.
8. Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to Baseline. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in IBS Symptom Severity
Change in total IBS Symptom Severity Scale (IBS-SSS) score from Baseline to Day 30.
Evaluates improvement in abdominal pain, bloating, stool pattern, and overall discomfort.
Reduction of greater than or equal to 50 points indicates clinically meaningful improvement.
2. Change in Stool Frequency
Change in the mean number of spontaneous bowel movements (SBMs) per week from Baseline to Day 30, based on the participant’s stool diary. 		 Visit 1 - Day 0
Visit 2 - Day 15 ± 2 days
Visit 3 - Day 30 ± 2 days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in IBS Quality of Life Questionnaire (IBS-QoL-36) score
Change in IBS Quality of Life Questionnaire (IBS-QoL-36) score from Baseline to Day 30.
Measures improvement in emotional, social, & physical well-being.
A higher score indicates improvement in overall health-related quality of life.
Participant’s overall perception of improvement at Day 30 compared with
Baseline. 		 Visit 1 - Day 0
Visit 2 - Day 15 ± 2 days
Visit 3 - Day 30 ± 2 days 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   13/01/2026 
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="4"
Days="0" 
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  

Introduction

Irritable Bowel Syndrome with constipation predominance is a chronic functional gastrointestinal disorder characterized by abdominal discomfort, altered bowel habits, infrequent bowel movements, bloating, and impaired quality of life. Conventional management options often provide inconsistent or temporary relief and may be associated with adverse effects, leading to increasing interest in complementary therapies. Triphala, a traditional Ayurvedic polyherbal formulation, has been widely used to support digestive health and bowel regularity and is known for its mild laxative, gut-modulating, and anti-inflammatory properties, suggesting potential benefit in constipation-predominant Irritable Bowel Syndrome.

Purpose of the Study

The purpose of this study is to evaluate the safety and efficacy of Triphala capsules administered once daily in adult participants diagnosed with constipation-predominant Irritable Bowel Syndrome. The study aims to assess improvement in symptom severity, stool frequency, and quality of life over a 30-day treatment period, along with monitoring tolerability and safety. The results of this study are expected to generate clinical evidence on the therapeutic potential of Triphala in the management of IBS-C.

 
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