| CTRI Number |
CTRI/2024/10/074787 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Local Application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Aargwadha Kshar local application on Piles(Arsha). |
|
Scientific Title of Study
|
Randomized controlled Clinical trial to evaluate the efficacy of Aargwadha Pratisarneeya Kshar in the management of Arsha (Second degree Internal Haemorrhoids). |
| 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.Kalyani Vilasrao Kale |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
MUHS Nashik. |
| Address |
Department of shalyatantra CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9403824599 |
| Fax |
|
| Email |
kalyanikale2705@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Swapnil More |
| Designation |
PG Guide & Associate Professor Shalyatantra department |
| Affiliation |
MUHS Nashik |
| Address |
OPD no 16 Department of Shalyatantra CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8983357106 |
| Fax |
|
| Email |
dr.swapnilmore23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Kalyani Vilasrao Kale |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
MUHS Nashik |
| Address |
OPD no 16 Department of shalyatantra CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhaji Nagar.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9403824599 |
| Fax |
|
| Email |
kalyanikale2705@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya Kanchanwadi,Chhatrapati Sambhaji Nagar,MAHARASHTRA, INDIA.431001. |
|
|
Primary Sponsor
|
| Name |
Dr Kalyani Vilasrao Kale |
| Address |
Department of Shalya tantra ,CSMSS Ayurved Mahavidyalaya
va Rugnalaya, Kanchanwadi, Chhatrapati Sambhaji Nagar Maharashtra,INDIA. 431001 |
| Type of Sponsor |
Other [SELF sponsered] |
|
|
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 Kalyani V Kale |
Chhatrapati Shahu Maharaj Shikshan Santhan Ayurved Mahavidyalay v Rugnalya . |
OPD no 16 Department of Shalyatantra ,Kanchanwadi, Chatrapati Sambhaji Nagar,Maharashtra,INDIA 431001.
Aurangabad
MAHARASHTRA |
9403824599
kalyanikale2705@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalaya Kanchanwadi Chhatrapati Sambhajinagar 431011 |
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 | Intervention Arm | Procedure | - | Ksharkarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: Sharangadhar samhita Madhyam khanda Chapter 11 shloka 102-103, Procedure details: Aragwadha Kshar is applied to second-degree internal hemorrhoids after rectal evacuation & patient preparation. The kshara is applied until the hemorrhoid turns pakwa Jambufala varna, followed by cleansing with lemon juice and water. Postoperative care includes sitz baths and laxatives, with the same procedure for Group B. Assessments occur on days 0, 7, and 14.)
(1) Medicine Name: Aargwadh Kshar, Reference: Sushrut samhita sutrasthan chapter 11 shloka 12, Route: Topical, Dosage Form: Kshara, Dose: 1(mg), Frequency: sos, Duration: 2 Weeks | | 2 | Comparator Arm | Procedure | - | Ksharkarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: Sharangdhar Samhita ,Madhyam khanda,chapter 11,shloka 102-105, Procedure details: Apamarga Kshar is applied to second-degree internal hemorrhoids after rectal evacuation & patient preparation. The kshara is applied with a spatula until the hemorrhoid turns pakwa Jambufala varna, followed by cleansing with lemon juice and water. Postoperative care includes sitz baths and laxatives, with assessments on days 0, 7, and 14.)
(1) Medicine Name: Apamarga Kshar, Reference: Sushrut Samhita sutrasthan 11th chapter 12th shloka, Route: Topical, Dosage Form: Kshara, Dose: 1(mg), Frequency: sos, Duration: 2 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Arsha with 2nd degree internal haemorrhoid will be taken for study. |
|
| ExclusionCriteria |
| Details |
Known case of 1st,3rd,4th degree haemorrhoids.
Patients having haemoglobin less than 8 gm%.
Known case of internal haemorrhoids associated withoter ano rectal disorderssuch as fistula-in-ano,fissure-in-ano.
Patients with bleeding disorder.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Size of Arshankura (Haemorrhoids
before
and after the treatment. |
baseline,7,14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Constipation
2. Vedana (pain)
3. Raktastrava (bleeding) per Rectal
|
On 7,14th day |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
11/10/2024 |
| 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 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
|
Main aim of ayurveda in to protect mankinds healthy life and to cure them from diseased conditions. A Change in lifestyle and dietary habits,such as consumption of fast food and spicy dishes can result in agnimandya and irregular bowel habits. One notable condition that arises from these factors is "ARSHA"a malady typically associated with adulthood and becoming more prevalant as one ages. The term "ARSHA" from thr root "RU-GATAU",with the addition of suffix ASUNA,signifying a threat to one’s well-being. This condition manifest as a protrusion of muscles that causes discomfort and can be likened to an adversary for patient. Acharya Sushruta considered six types of arsha i.e. Vataj,Pittaj,Kaphaj,Raktaj,Sanipataj&Sahaj. Haemorrhoids defined as dilated plexus of superior haemorrhoidal veins in relation to anal canal. |