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CTRI Number  CTRI/2022/08/044858 [Registered on: 23/08/2022] Trial Registered Prospectively
Last Modified On: 23/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Guda Pichu 
Scientific Title of Study   Comparative clinical study on the effect of Doorvadi Ghrita And Shatadhauta Ghrita Guda Pichu In Parikartika (Fissure-In-Ano) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr CHATURBHUJ 
Designation  1st YEAR POST GRADUATE SCHOLAR 
Affiliation  SDM COLLEGE OF AYURVEDA AND HOSPITAL, B.M ROAD, THANNIRUHALLA, HASSAN,KARNATAKA 
Address  Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka
Department of Shalya Tantra Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka
Hassan
KARNATAKA
573201
India 
Phone  9992185529  
Fax    
Email  chaturbhujmehra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasanna N Rao  
Designation  Professor Principal  
Affiliation  Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka  
Address  Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka
Department of Shalya Tantra Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka
Hassan
KARNATAKA
573201
India 
Phone  9448064277  
Fax    
Email  profpnrao@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prasanna N Rao  
Designation  Professor Principal  
Affiliation  Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka  
Address  Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka
Department of Shalya Tantra Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka
Hassan
KARNATAKA
573201
India 
Phone  9448064277  
Fax    
Email  profpnrao@gmail.com  
 
Source of Monetary or Material Support  
NOT APPLICABLE 
 
Primary Sponsor  
Name  Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka  
Address  Department of Shalya Tantra Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka  
Type of Sponsor  Private 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 Chaturbhuj  Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka   OPD NO 11 Department of Shalya Tantra Sri Dharmasthala College of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka
Hassan
KARNATAKA 		 9992185529

chaturbhujmehra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SDM COLLEGE OF AYURVEDA AND HOSPITAL B M ROAD THANNIRUHALLA HASSAN KARNATAKA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-picu, पिचु (Procedure Reference: SUSRUTHA SAMHITA, Procedure details: APPLICATION OF GUDA PICHU FOR 7 DAYS )
(1) Medicine Name: DOORVADI GRITHA, Reference: BHAISAJYA RATNAVALI, Route: Rectal, Dosage Form: Ghrita, Dose: 3(g), Frequency: bd, Duration: 7 Days
2Comparator ArmProcedure-picu, पिचु (Procedure Reference: SUSRUTHA SAMHITA, Procedure details: APPLICATION OF GUDA PICHU FOR 7 DAYS )
(1) Medicine Name: SHATADHOUTHA GRITHA, Reference: SHARANGADHARA SAMHITA, Route: Rectal, Dosage Form: Ghrita, Dose: 3(g), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Spasm of Anal sphincter
Presence of Fissure-in-ano.
Pregnancy.
Patients willing to participate and sign the informed consent form.
 
 
ExclusionCriteria 
Details  Patients with K/C/O Ulcerative colitis, Crohn’s disease, Tuberculosis
Patient with Carcinoma of rectum & anal canal
Patients with other systemic illness like uncontrolled diabetes mellitus (HbA1c > 8%), HIV and HBsAg positive patients.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To see the reduction in Pain, Constipation, Bleeding  To see the reduction in Burning Sensation after 7th,14th and 28 days

 
 
Secondary Outcome  
Outcome  TimePoints 
Size of ulcer
Sphincter tone
Ulcer healing
 		 7 DAYS 
 
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 1/ Phase 2 
Date of First Enrollment (India)   25/08/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Fissure in ano which is described as Parikartika in Ayurveda, is a very common and the most painful condition occurring in Ano-rectal region in day-to-day life. Incidence is around 1 in 350 adults and most often occur in adults aged 15-40 years. Parikartika is characterized with Kartanavat Shoola, Daha and Anilasanga in the region of Guda, Nabhi, and Medra along with Aruchi. Importance is laid because of its higher recurrence rates.

Parikartika has reference in all the Brihatrayees not as a separate entity, but as a complication of improper administration of treatmemt procedures like Virechana, Bastikarma Vyapad and as a complication of diseases like Atisara, Grahani and Udavarta caused by vitiation of Vata & Pitta.

Chikitsa for Parikartika mentioned by Charaka are Pichu with Sarpi and Pichha Basti. Keeping this point of view, the present study focuses on evaluating the comparative effectiveness of Doorvadi Ghrita and Shatadhauta Ghrita in Parikartika to reduce pain, bleeding, burning sensation, sphincter spasm and promotes ulcer healing. Shatadhauta Ghrita and Doorvadi Ghrita are selected as they are having effective Vrana Ropana and Vrana Shodhana properties.

OBJECTIVE: To compare the effectiveness Of Doorvadi Ghrita Guda Pichu with Shatadhauta Ghrita Guda Pichu in the Management of Parikartika (Fissure in Ano).

METHODOLOGY: Interventional clinical study

Sample size: 40

Groups: 2; 20 subjects in each group

Group A- Taken as Standard group for Guda Pichu of Doorvadi Ghrita.

Group B- Taken as Trial group for Guda Pichu of Shatadhauta Ghrita. 
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