| CTRI Number |
CTRI/2025/07/090968 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Basti Procedure] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Management of Parikartika by Sarjarasadi Dugdha Basti and Yashtimadhu tail matra basti |
|
Scientific Title of Study
|
Evaluation of Efficacy of Sarjrasadi Dugdha Basti In Comparison To Yashtimadhu Tail Matra Basti in The Management of Parikartika WSR to Basti Vataharanam |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Minaxhi Mujalde |
| Designation |
MD Scholar |
| Affiliation |
Pandit Khushilal Sharma Goverment Ayurvrda College Bhopal MP |
| Address |
Pg Department of Samhita Siddhant Pandit Khushilal Sharma Goverment Ayurvrda College Bhopal MP
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
6261601089 |
| Fax |
|
| Email |
minakshimujalde08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Malviya |
| Designation |
Associate Proffessor |
| Affiliation |
Pandit Khushilal Sharma Goverment Ayurvrda College Bhopal MP |
| Address |
Pg Department of Samhita Siddhant Pandit Khushilal Sharma Goverment Ayurvrda College Bhopal MP
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827217181 |
| Fax |
|
| Email |
kkumar.rajesh319@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Minaxhi Mujalde |
| Designation |
MD Scholar |
| Affiliation |
Pandit Khushilal Sharma Goverment Ayurvrda College Bhopal MP |
| Address |
Pg Department of Samhita Siddhant Pandit Khushilal Sharma Goverment Ayurvrda College Bhopal MP
MADHYA PRADESH
462003
India |
| Phone |
6261601089 |
| Fax |
|
| Email |
minakshimujalde08@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pandit Khushilal Sharma Goverment Ayurveda College Bhopal Mp |
| Address |
Science Hills Behind Manit Kolar Road Bhopal MP |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Minaxhi Mujalde |
Pandit Khushilal Sharma Goverment Ayurveda College Bhopal Mp |
Room no. 231 Pg department of Samhita Siddhant Science Hills Behind Manit Kolar Road bhopal MP
Bhopal
MADHYA PRADESH |
06261601089
minakshimujalde08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Pt Khushilal Sharma Goverment Ayurveda Institute Bhopal Mp |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Siddhi Sthan 7/56, Procedure details: Sarjrasadi Dugdha Basti given daily)
|
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Parikartika having duration less than two months
Patient full filling the diagnostic criteria
Patient willing to sign the written consent for participation the study
Patient fit for Basti karma. |
|
| ExclusionCriteria |
| Details |
Patients suffering from malignancy of ano-rectum or any other organ
Patients Positive for HIV VDRL Hepatitis B
Fissureinano associated with piles and fistula
Uncontrolled cases of Diabetes Mellitus and Hypertension
any other systemic disorder Ulcerative colitis Crohns disease Tuberculosis |
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of the study we would be able to evaluate the efficacy sarjrasadi
dugdha basti in the management of parikartika to substantiate Basti Vata Haranam |
Duration of the treatment will alternate days of the medicine 17-17 days |
|
|
Secondary Outcome
|
|
|
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)
|
01/08/2025 |
| 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="6"
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
|
Parikartika fissure in ano is a painful and common anorectal disorder affecting around forty percenty of cases seen in all age groups and genders It is primarily caused by factors like hard stool irregular and spicy diet faulty bowel habits and poor hygiene
Modern medical treatments such as NSAIDs bulk laxatives and local anesthetic ointments offer only limited relief Surgical intervention though available is often avoided due to associated complications like anal incontinence recurrent ulcers and persistent mucus discharge
Recently a significant rise in Parikartika cases has been noted with patients showing a shift toward Ayurvedic treatment due to dissatisfaction with modern options Therefore there is a growing need to explore and research classical Ayurvedic formulations
In this context Sarjarasadi Dugdha Basti and Yashtimadhu Tail Basti have been selected based on their vranaropana wound healing vatapittaghna balancing Vata and Pitta and dahashamana relieving burning sensation properties offering a promising alternative in the management of Parikartika |