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CTRI Number  CTRI/2025/07/090365 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "A Comparison of Kutaj Bark and Seeds in Treating Bleeding Piles (Raktarsh 
Scientific Title of Study   A Comparative Study of Kutaj (Holarrhena antidysenterica Linn) Bark and Seeds in the Management of Raktarsh 
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 Nandni choudhary 
Designation  M.D. scholar Dravyaguna 
Affiliation  Pt Khushilal Sharma government autonomous Ayurveda college and Institute Bhopal MP 
Address  Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhya pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  7974458400  
Fax    
Email  nandnichoudhari97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K C Garg  
Designation  HOD Reader 
Affiliation  Pt Khushilal Sharma government autonomous Ayurveda college and Institute Bhopal MP 
Address  41 Triupati nagar neelbad bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  8821903928  
Fax    
Email  gargkamalcharan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K C Garg  
Designation  HOD Reader 
Affiliation  Pt Khushilal Sharma government autonomous Ayurveda college and Institute Bhopal MP 
Address  41 Triupati nagar neelbad bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  8821903928  
Fax    
Email  gargkamalcharan@gmail.com  
 
Source of Monetary or Material Support  
Pt. Khushilal Sharma Govt. Auto Ayurveda College and Institute, Bhopal, M.P., India, pincode 462003 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Govt Auto Ayurveda College and Institute Bhopal MPIndia  
Address  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute science and Hills Center Behind MANIT Bhopal M.P.India 462003 
Type of Sponsor  Government medical college 
 
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 Nandni choudhary  Pt. khushilal sharma government autonomous ayurveda college and Institute BhopaL M.P.  Opd no.3 Department of Shalya Tantra, Hospital Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal M.P.
Bhopal
MADHYA PRADESH 		 07974458400

nandnichoudhari97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Bhopal M.P. India   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: RAKTAJA-ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kutaj seeds, Reference: Madanpal nighantu. 1/148, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: fresh jwatha on every day
2Comparator ArmDrugClassical(1) Medicine Name: Kutaj Bark , Reference: astang sangrah chikitsha. 10/188, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - Kwatha should be prepared fresh on every day
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals aged between 18 and 60 years without any dis-crimination of gender, caste, religion, etc.
2. Patients fulfilling the diagnostic criteria.
3. Individuals having clinical signs and symptoms of Raktarsh (Bleeding piles) according to ayurvedic classics.
4. Anorectal Arsh only where bleeding is present.
5. Piles examined by proctoscope.
6. Individuals who will give written consent for the study.
 
 
ExclusionCriteria 
Details  1. Individuals having any other known systemic disorders like cardiac disorders, renal and hepatic impairment, diabetes mellitus, gynecological diseases and any type of cancer.
2. Pregnant and lactating mothers.
3. Severely Anemic.
4. Crohn’s disease
5. Irritable bowel syndrome
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvment in subjective parameter of Raktarsh
1. Raktsrava (bleeding)
2. Vibandha (constipation)
3. Daurbalya (weakness)
 		 21 Days
 
 
Secondary Outcome  
Outcome  TimePoints 
HB RBS  21 DAYS 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   02/09/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 aim of the study is to provide a simple safe and herbal drug for patients of Bleeding piles and to evaluate the comparative efficacy of Kutaj bark and Kutaj seeds in the management of Bleeding piles (Raktarsh).  
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