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CTRI Number  CTRI/2022/05/042828 [Registered on: 26/05/2022] Trial Registered Prospectively
Last Modified On: 25/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study conducted to see the effect of Gandhaka Druti Pichu and Yastimadhu Taila Pichu in Fissure. 
Scientific Title of Study   “A Comparative Clinical Study to evaluate the efficacy of Gandhaka Druti Pichu and Yastimadhu Taila Pichu in the management of Parikartika with special reference to Acute 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 Mahalaxmi Bilagi 
Designation  MS PG Scholar Shalyatantra 
Affiliation  BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 
Address  Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus

Bagalkot
KARNATAKA
587101
India 
Phone  9902527344  
Fax    
Email  mahalaxmibilagi9845@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M M Salimath 
Designation  Principal and Professor 
Affiliation  BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 
Address  Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus

Bagalkot
KARNATAKA
587101
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr M M Salimath 
Designation  Principal and Professor 
Affiliation  BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 
Address  Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus

Bagalkot
KARNATAKA
587101
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Source of Monetary or Material Support  
BVVS Ayurved Medical College and Hospital, Bagalkot, KArnataka - 587101 
 
Primary Sponsor  
Name  BVVS Ayurved Medical College and Hospital 
Address  BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot, Karnataka-587101 
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 Mahalaxmi Bilagi  BVVS Ayurved Medical College and Hospital   Shalyatantra OPD Room No: 03 BVVS Ayurved Medical College and Hospital
Bagalkot
KARNATAKA 
9902527344

mahalaxmibilagi9845@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka  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-Guda Pichu (Procedure Reference: Su.Chi1/40, Procedure details: Patient will be educated about the procedure. Patient will be adviced to clean the perianal region.Then after taking the comfortable position, adviced to insert the medicated Pichu in the anal region, it should be removed after 6 hours. The patient is advised to do the same procedure twice a day for 7 days. )
(1) Medicine Name: Gandhaka Druti, Reference: RRS 3/32-33, Route: Topical, Dosage Form: Taila, Dose: 0.5(ml), Frequency: bd, Duration: 7 Days
2Comparator ArmProcedure-Guda Pichu (Procedure Reference: Su.Chi1/40, Procedure details: Patient will be educated about the procedure. Patient will be adviced to clean the perianal region.Then after taking the comfortable position, adviced to insert the medicated Pichu in the anal region, it should be removed after 6 hours. The patient is advised to do the same procedure twice a day for 7 days. )
(1) Medicine Name: Yastimadhu Taila, Reference: Su.Chi.34/16, Route: Topical, Dosage Form: Taila, Dose: 0.5(ml), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with Parikartika (acute
fissure- in-ano)
2.Patients with diabetes and hypertension which are
under control 
 
ExclusionCriteria 
Details  1. Patients diagnosed with other co-existing Ano
rectal diseases.
2. Fissure in ano due to systemic disorders.
3. Patients suffering from infectious diseases.
4. Patients of chronic fissure in ano with
sentinel pile.
5. Pregnant women & lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain, burning sensation, bleeding per rectum and constipation   15 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the size of ulcer.
Improvement in the wound healing
 
15 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   N/A 
Date of First Enrollment (India)   31/05/2022 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mahalaxmibilagi9845@gmail.com].

  6. For how long will this data be available start date provided 31-05-2022 and end date provided 31-05-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

                 Parikartika is one of the most painful and commonest condition in Gudagata Vikaras affecting majority of the population in modern world. Acharya’s have explained it as one among the Vamana Virechana Vyapat and Bastivyapat. It is caused by Sthana Samshraya of vitiated Vata & Pitta Dosha’s in Gudapradesh, leading to Kartanavat Vedana and Daha in Gudapradesh. It can be correlated to fissure-in-ano based on signs and symptoms.

                 Fissure-in-ano is an elongated ulcer in longitudinal axis of lower anal canal associated with constipation, severe pain & burning sensation during defecation and bright red bleeding. In acute type pain is so severe that, patient develops fear for defecation and this further worsens the condition. Fissure-in-ano occurs most commonly in midline posteriorly, in males usually posteriorly 95%, anteriorly 5%, & in females posteriorly 80%, & anteriorly 20%. About 30–40% of the population suffers from proctologic pathologies at least once in their lives, in that anal fissure comprises of 10–15%. It occurs equally in both men & women and is common in all age groups especially adults of 15-40 years. The incident is supposed to be high in one who passes hard & dry stool.

                In the Chikitsa of Parikartika, Acharyas have mentioned Madhura, Kashaya Rasa Sneha Yukta Dravya’s in the form of Piccha Basti, Anuvasana Basti, Pichu, Varti & Lepa, which pacifies Vata and Pitta Dosha’s. Acharya Sushrutha has mentioned Anuvasana Basti with Grithamanda & Yastimadhu Taila in Parikartika.

                Acharya Sushrutha has mentioned Pichu Prayoga in the context of Shashti Upakrama, in the management of Vrana.

                Yastimadhu Taila is having Vata-Pittahara Guna, Sheeta Veerya, which acts as Dahaprashamaka and Vranaropaka, hence it is taken as standard drug by previous research works done.

                   Gandhaka Druti is mentioned in Rasa Ratna Samucchaya in the context of Uparasas, It is Taila obtained of Gandhaka, which acts as Vedanasthapaka and Vranaropaka, so it has been selected in the treatment of Parikartika.

                 Hence the present study is under taken to evaluate and compare the efficacy of Gandhaka Druti Pichu and Yastimadhu Taila Pichu in the management of Parikartika w.s.r to Acute Fissure-in-Ano.

 
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