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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•रà¥à¤® | (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. |