CTRI

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CTRI Number

CTRI/2025/09/095012 [Registered on: 17/09/2025] Trial Registered Prospectively

Last Modified On:

10/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

comparison of madhuchchhishtadi ghrita and prapaundarikadi ghrita in parikartika fissur-in-ano

Scientific Title of Study

Comparative Clinical Evaluation of Madhuchchhishtadi Ghrita and Prapaundarikadi Ghrita in Parikartika( Fissure in ano)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Urvashi
Designation	MS Scholar
Affiliation	UAU Gurukul Campus Haridwar Uttarakhand
Address	OPD 7 Department of Shalya Tantra Uttarakhand Ayurved University Gurukul Campus haridwar Hardwar UTTARANCHAL 249404 India
Phone	9528808910
Fax
Email	Singhu1128@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Devesh Shukla
Designation	Associate Professor Dept. of shalya tantra
Affiliation	UAU Gurukul Campus Haridwar Uttarakhand
Address	OPD no 07 Department of Shalya Tantra UAU Gurukul Campus Haridwar Uttarakhand Hardwar UTTARANCHAL 249404 India
Phone	09412155386
Fax
Email	drdeveshshukla@gmail.com

Details of Contact Person
Public Query

Name	Dr Devesh Shukla
Designation	Associate Professor Dept. of shalya tantra
Affiliation	UAU Gurukul Campus Haridwar Uttarakhand
Address	OPD no 07 Department of Shalya Tantra UAU Gurukul Campus Haridwar Uttarakhand Hardwar UTTARANCHAL 249404 India
Phone	09412155386
Fax
Email	drdeveshshukla@gmail.com

Source of Monetary or Material Support

PG department of Shalya Tantra Uttarakhand Ayurved University gurukul campus Haridwar uttarakhand India 249404

Primary Sponsor

Name	UAU Gurukul Campus Haridwar
Address	OPD no 7 PG Department of Shalya Tantra uttarakhand ayurved university Gurukul Campus Haridwar uttarakhand India 249404
Type of Sponsor	Other []

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 urvashi	Gurukul campus Uttarakhand ayurveda university	OPD no 7 Deptt of shalya tantra Gurukul campus haridwar Uttarakhand Hardwar UTTARANCHAL	9528808910 Singhu1128@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee uttarakhand ayurved university gurukul campus haridwar uttarakhand	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:K00-K95\|\|Diseases of the digestive system. Ayurveda Condition: PARIKARTIKA,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Madhuchchhishtadi, Reference: sushruta samhita, Route: Topical, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Prapaundarikadi ghrita, Reference: Chakradatta, Route: Topical, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	10.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. patient who have clinical symptoms of parikartika( Fissure-in ano). 2. Patient of age group between 10-60 yrs of age. 3. Patient of either sex be selected.

ExclusionCriteria

Details

1. Patient below 10 yrs and above 60 yrs of age.
2. Patient with uncontrolled DM, HTN.
3. Known case of Malignanacy, Ulcerative collitis, syphillis and tuberculosis.
4. HIV, HCV and HbsAg positive Patients.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
assessment will be done on the basis of: bleeding per rectum burning sensation itching pain constipation	assessment will be done weekly for 21 days i.e. on 0 day, 7th day, 14th day and 21st day.

Secondary Outcome

Outcome	TimePoints
Cure of Fissure-in-ano	1 months

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

Phase 2

Date of First Enrollment (India)

29/09/2025

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

This present study aimed to compare the clinical efficacy of madhuchchhishtadi ghrita and prapaundarikadi ghrita in the managment of parikartika. Diagnosed cases of parikartika shall be selected from opd and ipd of Dept. of Shalya Tantra Gurukul Campus, UAU irrespective of caste and religion . There will be 2 groups, 16 patients of Group A will be given local application of madhuchchhishtadi ghrita in fissure in ano for 21 days. 16 patients of Group B will be given local application of prapaundarikadi ghrita in fissure-in-ano for 21 days. patients having the classical signs and symptoms of parikartika as per proforma and follow up period will be of 1 month.