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CTRI Number  CTRI/2023/09/057363 [Registered on: 11/09/2023] Trial Registered Prospectively
Last Modified On: 06/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of palash pratisarniya kshara on hemorrhoids 
Scientific Title of Study   A clinical study to evaluate the efficacy of Palash pratisarniya kshara in the management of Arsha W.S.R to hemorrhoids  
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 Bhagirath Mal Garhwal 
Designation  PG Scholar 
Affiliation  Madan Mohan Malaviya Government Ayurved college Udaipur 
Address  PG Scholar Shalya tantra Department Madan Mohan Malaviya Government Ayurved College Udaipur PIN 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9928001221  
Fax    
Email  bmgarhwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harimohan Meena 
Designation  Professor  
Affiliation  Madan Mohan Malaviya Government Ayurved college Udaipur 
Address  Professor Shalya tantra Department Madan Mohan Malaviya Government Ayurved College Udaipur PIN 313001

Udaipur
RAJASTHAN
313001
India 
Phone  8005974549  
Fax    
Email  dr_harimohan@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harimohan Meena 
Designation  Professor  
Affiliation  Madan Mohan Malaviya Government Ayurved college Udaipur 
Address  Professor Shalya tantra Department Madan Mohan Malaviya Government Ayurved College Udaipur PIN 313001


RAJASTHAN
313001
India 
Phone  8005974549  
Fax    
Email  dr_harimohan@rediffmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malaviya Government Ayurved College Udaipur 
 
Primary Sponsor  
Name  Madan Mohan Malaviya Government Ayurved College Udaipur 
Address  Madan Mohan Malaviya Government Ayurved College Udaipur PIN 313001  
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 Bhagirath Mal Garhwal  Madan Mohan Malaviya Government Ayurved College Udaipur  OPD No 1 PG Department of Shalya tantra Associated group of hospitals Madan Mohan Malaviya Government Ayurved College Udaipur PIN 313001
Udaipur
RAJASTHAN 		 9928001221

bmgarhwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,M.M.M. Govt.Ayurved College,Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: Sushrutha samhitha, Procedure details: Pratisarniya kshara karma will be done in the interval of 1 week for the duration 1 month. Kshara will be applied for 60 seconds and washed with lemon juice..)
(1) Medicine Name: Palash kshara, Reference: Susrutha samhitha, Route: Topical, Dosage Form: Kshara, Dose: 500(mg), Frequency: od, Duration: 1 Months
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients suffering from signs and symptoms of arshas
2)Second and third degree piles 
 
ExclusionCriteria 
Details  1)age below 20 yrs and above 60 yrs
2)first and fourth degree piles
3)inflammed,prolapsed and thrombosed piles 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Improvement in signs & symptoms of arshas
2)Reduction in bleeding,pain & protrusion of pile mass 		 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
1)Improvement in signs & symptoms of arshas
2)Reduction in bleeding,pain & protrusion of pile mass 		 2 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   15/09/2023 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This is a single arm study to evaluate the efficacy of palash pratisarniya kshara. In this study 30 patients will be administered with palash pratisarniya kshara in the interval of 1 week for the duration of 1 month. 
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