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CTRI Number  CTRI/2021/08/035526 [Registered on: 09/08/2021] Trial Registered Prospectively
Last Modified On: 04/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role Of Apamarga Kshar Lepa And Chitrak Ksahr Lepa In Haemorrhoids 
Scientific Title of Study   A Comparative Clinical Study Of Apamarga Kshar Patan And Chitrak Kshar Patan In Arsha (2ND Degree Haemorrhoids) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishal Verma 
Designation  Professor 
Affiliation  Rishikul Campus, Haridwar, Uttarakhand Ayurved University 
Address  OPD No.7, Department Of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
249401
India 
Phone  9719314634  
Fax    
Email  Vishalverma100@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankit Kumar Nema 
Designation  P.G. Scholar Shalya Tantra 
Affiliation  Rishikul Campus, Haridwar, Uttarakhand Ayurved University 
Address  OPD No.7, Department Of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
249401
India 
Phone  8989435819  
Fax    
Email  ankit.nema1991@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankit Kumar Nema 
Designation  P.G. Scholar Shalya Tantra 
Affiliation  Rishikul Campus, Haridwar, Uttarakhand Ayurved University 
Address  OPD No.7, Department Of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
249401
India 
Phone  8989435819  
Fax    
Email  ankit.nema1991@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus, Devpura, Haridwar, Uttarakhand Ayurved University , pin-249401 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University Railway Road, Harrawala 
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 Ankit Kumar Nema  Rishikul Campus Haridwar Uttarakhand Ayurved University  O.P.D. no. 7, Department of Shalya Tantra, Rishikul college
Hardwar
UTTARANCHAL 
8989435819

ankit.nema1991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttarakhand Ayurved University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: sushurta sutra 11/7, Procedure details: The procedure of selected patient will be done in lithotomy position. First of all anal canal and perianal area will be cleaned with antiseptic lotion. Proctoscopic examination will be done for confirmation of number and position of the Arsha. These Arsha will be made to protrude in the slit proctoscope. After that Kshar will be applied with spatula on Arsha and then we will wait for 100 Matrakal (about 2 minutes). Then the applied Kshar will be washed with Nimbu Swaras or Kanji. After the proce)
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  01.Patient of any sex, caste, religion & occupation
02.Patients who are suffering from second degree of Arsha will be selected in this study 
 
ExclusionCriteria 
Details  01.1St,3rd, 4th degree of haemorrhoids
02.Arsha associated with Ca Rectum,thrombosed, & strangulated piles, rectal prolapse and fistula in ano
03.Hepatitis-B, HIV, HCV, and VDRL positive cases will be excluded
04.suspected case of CoVid-19 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Outcome will be measured with the parameters -
01.Pain or discomfort in anal region
02.Itching in anal region
03. Bleeding per anus
04.number of pile mass
05.Size of pile mass 
Total 3 sittings of kshar patan in every 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
01. constipation
02. mucous discharge 
Total 3 sittings of kshar patan in every 7 days 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   N/A 
Date of First Enrollment (India)   15/08/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Arsha is one of the common problems among ano-rectal disorders and it has been reported since thousands of years. This disease causes pain or discomfort, bleeding associated if piles are prolapsed, constipation, mucus discharge, peri-anal itching and other symptoms, which affects daily routine of patients. Because of its severity, Duschikitsya in nature,  Acharya Sushruta has considered it as one among Ashtamahagada. Etiopathogenesis and clinical presentation  of the disease Arshha is very similar to Haemorrhoids. It is varicosities of venous plexus in the wall of anal canal and lower most half inch of rectum. Haemorrhoidal venous plexus along with abnormally displaced enlarged anal cushion characterized by inflamed or prolapsed pile mass, bleeding per rectum and some discharge from anus.In modern science, curative techniques for Haemorrhoids like Rubber band ligation, Cryosurgery, Infrared photo coagulation are in practice. Unfortunately these invented techniques have their own limitations as well as have not been proven free from post operative complications. For these reasons there is a continuous search for newer methods.Need of the hour is finding out an Ayurvedic treatment methodology which is free from severe post operative complications.

AIMS AND OBJECTIVE

· To find out an effective para-surgical mode of management for second degree of Arsha .

· To find out efficacy of Apamarga Kshar in the form of Kshar Patan in the management of second degree of Arsha.

· To find out efficacy of Chitrak Kshar in the form of Kshar Patan in the management of second degree of Arsha.

· To compare the efficacy of Apamarga Kshar and Chitrak Kshar in the management of second degree Arsha.

· To note the adverse effect of the trial drug, if any.

· To decrease the intensity of Pain, Itching and constipation so that the patient can do his routine works comfortably.

 
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