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CTRI Number  CTRI/2025/03/082897 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate efficacy of Patha Tail Pichu In Management Of Parikartika W.S.R. To Acute Fissure In Ano 
Scientific Title of Study   Randomised controlled clinical trial to evaluate the efficacy of Patha Tail Pichu In Management Of Parikartika W.S.R. To Acute 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  Dr Suyash Ravindra Golde 
Designation  PG Scholar 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  8975284033  
Fax    
Email  Suyashgolde@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrShailendra Pandurang Savant 
Designation  Reader 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  9158574943  
Fax    
Email  Shailendrasavant@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrShailendra Pandurang Savant 
Designation  Reader 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502


MAHARASHTRA
416502
India 
Phone  9158574943  
Fax    
Email  Shailendrasavant@yahoo.com  
 
Source of Monetary or Material Support  
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 
 
Primary Sponsor  
Name  Dr Suyash Ravindra Golde 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 
Type of Sponsor  Other [Self] 
 
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 Suyash Ravindra Golde  Late Kedari Redekar Dharmadaya Rugnalaya shalyatantra opd ,Gadhinglaj, Kolhapur  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA 
8975284033

Suyashgolde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj, kolhapur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-picu, पिचु (Procedure Reference: Sushrut sutrasthan, Procedure details: After cleaning the site a pichu soaked in patha tail will be placed at the site of fissure overnight)
(1) Medicine Name: Durvadi tail, Reference: Yogratnakar sadyovranachikitsa, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 7 Days
2Intervention ArmProcedure-picu, पिचु (Procedure Reference: Sushrut sutrasthan 38/46-47, Procedure details: After cleaning the site a pichu soaked in patha tail will be placed at the site of fissure overinght)
(1) Medicine Name: Patha tail, Reference: Sushrut sutrasthan 38/46-47, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 7 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Acute fish in ano without sentinal tag. 
 
ExclusionCriteria 
Details  Chronic fissure in ano, suspected malignancies, fissure in ano secondary to ulcerative colitis, crohns disease 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief From symptom within seven days  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Healing of fissure better than durvadi tail in short duration of time  7 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/04/2025 
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 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  

According to Ayurveda Parikartika is treated by internal palliative medicine and local

therapies like Anuvasanabasti, Picchabasti, Pichu dharana, Tailapooran, lepa, are

given prime importance in management of parikartika.

In allopathy, the conservative management of an acute fissure in ano is pain relief,

soothing ointment and stool softner and surgical managemrnt like Lord’s anal dilation

fissurectomy, Left Lateral Sphincterotomy. This procedure has its own complication

like incontinence which is more horrible than the actual pathology.

Patha is very effective daha shamak, sthambak and shola nashak also patha is

mentioned in ambashtadi gana by acharya Sushrut which has vrana ropak properties

so it helps in reliveing the symptoms and healing of the disease. Hence the concept

of using patha is derived. Patha taila pichu will be used in this study which can be

done by self, and also it is very much cost effective.

As the disease in itself is very disturbing and can be managed conservatively in acute

stage, so more and more study should be conducted for the betterment of the

patient.

Many studies have been conducted on conservative management of Parikartika in

various Ayurved institutes around the country. However they have anecdotal

approach so we decided to evaluate the efficacy of the proposed drug i.e Patha taila

pichu in management of parikartika w.s.r to Fissure in ano.




 
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