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CTRI Number  CTRI/2023/05/052540 [Registered on: 11/05/2023] Trial Registered Prospectively
Last Modified On: 01/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of Acute fissure with jatyadi grta pichu and Katupiladi grta pichu. 
Scientific Title of Study   Efficacy of Katupiladi Ghrita Pichu and Jatyadi Ghrita Pichu in the management of Parikartika (Acute fissure- in- ano) An open labelled randomized controlled clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna R Chandran 
Designation  MS Ayurveda Scholar 
Affiliation  ITRA 
Address  ITRA Department of Shalya tantra,Institute of Teaching and Research in Ayurveda,PN Marg Opposite City-B division police station,Jamnagar,Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  6282496025  
Fax    
Email  krishnarchandran1992@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pashmina B Joshi 
Designation  Associate Professor 
Affiliation  ITRA 
Address  ITRA Department of Shalya Tantra,Institute of Teaching and Research in Ayurveda,PN Marg Opposite City-B division Police station,Jamnagar,Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  pbj@itra.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Pashmima B Joshi 
Designation  Associate Professor 
Affiliation  ITRA 
Address  Institute of Teaching and Research in Ayurveda,Department of Shalya tantra,PN Marg Opposite City -B division Police station ,Jamangar,Gujara

Jamnagar
GUJARAT
361008
India 
Phone  9427226504  
Fax    
Email  pbj@itra.edu.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar 
 
Primary Sponsor  
Name  ITRA 
Address  ITRA Department of Shalya tantra,Institute of Teaching and Research in Ayurveda,PN Marg Opposite City-B division police station,Jamnagar,Gujarat 
Type of Sponsor  Research institution and hospital 
 
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 
Krishna R Chandran  ITRA Hospital  Institute of teaching and research in Ayurveda,Opp to B Division Police station
Jamnagar
GUJARAT 		 6282496025

krishnarchandran1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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
1Intervention ArmProcedure-picu, पिचु (Procedure Reference: charaka samhita chikitsa sthana 19 chapter 46th sloga number, Procedure details: Gauze piece smeared in Ghrita should placed inside anal canal.)
(1) Medicine Name: Katupiladi ghrita, Reference: folk medicine, Route: Rectal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Duration: 2 Weeks
2Comparator ArmProcedure-picu, पिचु (Procedure Reference: charaka samhita chikitsa sthana 19th chapter 46th sloga number, Procedure details: Gauze piece smeared in Ghrita should placed in anal canal.)
(1) Medicine Name: Jatyadi Ghrita, Reference: Astanga Hrdaya uttara sthana 25th chapter 67th sloga number, Route: Rectal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Duration: 2 Weeks
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients of Parikartika Acute fissure-in-ano having duration less than upto 4weeks.
2.Age group between 20-50years of either gender.
3.Controlled Hypertension and Diabetes mellitus
 
 
ExclusionCriteria 
Details  1. Fissure-in-ano having duration- more than 4 weeks or as developed sentinel tag.
2. Age group less than 20 years and greater than 50 years.
3. Patient suffering from malignancy.
4. Patient suffering from HIV, VDRL, Hepatitis-B, T.B, HCV, Paralysis,Parkinsonism, Known case of cardiac diseases (H/O- MI, IHD) or secondary causes.
5. Fissure-in-ano associated with fistula and fissure bed infections.

6. Multiple fissure in ano.
7. Ulcerative colitis, Crohn’s disease,STD .
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in signs and symptoms of Parikartika that is absence of bleeding per ano , absence of linear ulcer of true skin of anal canal which comes under subjective criteria and reduction in pain in ano which will be assessed by VAS Scale and reduction in spasm in ano which comes under subjective criteria .  Relief in signs and symptoms of parikartika after 2 weeks of completion of treatment and follow up on every 15 days for 1 month. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessement of subjective criteria that is absence of bleeding per ano , absence of linear ulcer of true skin of anal canal and reduction in pain in ano which will be assessed by VAS Scale, reduction in spasm in ano which comes under subjective criteria .  Relief in signs and symptoms of parikartika after 2 weeks of completion of treatment and follow up on every 15 days for 1 month. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/05/2023 
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   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 The health of an individual depends solely on his diet & life style. Diet plays very important role.Parikartika  (Acute fissure in ano)which is evident by references.

 Fissure-in-ano is a most troubling and painful condition. They can be acute or chronic and often cause symptoms and suffering out of proportion to the size and size of lesion.

 Fissure are more commonly encountered in younger and middle aged adults, but also occur in children and elderly. Both sexes are affected equally.

 The Vast majority of Fissure is a linear ulceration from dentate line to anal verge. Majority of fissures occur as a single tear in midline. Mostly 75% to 90% occur in the posterior midline. Acute anal fissures appear as a longitudinal or elliptical tear in mucosal lining of anal canal. When symptoms are present for more than 8 to 12 weeks, the fissure often develops chronicity.

 In Ayurveda, the vitiated Apanavayu can be considered as a chief causative factor for the manifestation of Parikartika. In Ayurveda, the detailed description of Parikartika has been found in scattered manner in Samhita as a complication of various diseases like Vatika Jwara(Ch.Chi.3/186), Vatika Pakva Atisara(Ch.Chi.19/5), Sahaja Arsha (Ch.Chi.14/8), Kaphaja Arsha(Ch.Chi.14/17), Arsha Purvarupa (Su.Ni.2/8), Udavarta (Ch.Chi.26/5-6) in Garbhani (Ks. Kh. 10/10), unlawful administration of purgative or enema (Ch.Si. 6/62). Later on especially Kashyapa and Sharangdhara have described the details regarding the Doshika types. Kashyapa has mentioned three types of Parikartika according to predominance of the Doshaand their treatment accordingly. As per the classical description of signs and symptoms, the disease Parikartika is correlated with fissure in ano in modern parlance.

 Significance: Acute fissure is a condition that affects a great majority of the population and occurs at any age irrespective of gender having prevalence rate approximately 30% to 40% of total ano- rectal diseases.This disease of anus demand urgent relief from burning pain.Due to severe anal pain most of patient demand conservative management at OPD level

Aims and objectives:

1.To evaluate and compare the clinical effect of Katupiladi Ghrita Pichu and Jatyadi Ghrita Pichu in the  management of Parikartika(Acute fissure in ano).

2.To compare Katupiladi Ghrita and Jatyadi Ghrita for their pharmacognostical and phytochemical properties.

 

Materials and Methods:

Patients of parikartika(Acute fissure in ano) having signs and symptoms of acute fissure          in ano that is burning pain in ano,bleeding per ano(streak of blood with stool),increased spasm tone,linear ulcer in anal canal will be selected from OPD/IPD of Shalya Tantra, I.T.R.A ,Jamnagar,irrespective of gender,occupation,caste and religion etc.


Grouping of patients:

The patients will be divided randomly into A and B groups by computer generated Randomization method viz. (Minimum 15 patients in each group).

 

Group-A: Local application of Katupiladi Ghrita ( Pichu) in fissure bed (Parikartika) ?(Acute fissure in ano)twice a day after sitz bath for 2 weeks.

 

Group-B (Standard control): Local application of Jatyadi Ghrita Pichu in fissure bed, twice a day after sitz bath for 2 weeks.

 Results and Discussion: Data generated during the above study will be present in a Systemic    manner and shall be analyzed statically. Where the important points of the Conceptual study,  Analytical study, Pharmacological study will be discussed.

 Follow up: After completion of therapy, follow up will be done after 15 days of 2 sittings to assess the status  of patient, where patient will be asked to report.

  Adverse effects: This drug have no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.

 

 
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