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CTRI Number  CTRI/2024/07/071129 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the effect of Kajjalikodaya Malahara Pichu and Jatyadi Ghrita Pichu in the management of Parikartika with special reference to Acute Fissure-in-Ano.” 
Scientific Title of Study   A Randomized Comparative Clinical Trial to evaluate the efficacy of Kajjalikodaya Malahara Pichu and Jatyadi Ghrita Pichu in the management of Parikartika with special reference 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 Pravin Birajadar 
Designation  PG Scholar 
Affiliation  BVVS Ayurved Medical College and Hospital  
Address  Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9960516461  
Fax    
Email  pravinbirajadar2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pallavi A Hegde 
Designation  Professor 
Affiliation  BVVS Ayurved Medical College and Hospital  
Address  Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9448636321  
Fax    
Email  drpallaviah@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pallavi A Hegde 
Designation  Professor 
Affiliation  BVVS Ayurved Medical College and Hospital  
Address  Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9448636321  
Fax    
Email  drpallaviah@rediffmail.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 Pravin Birajadar  BVVS Ayurved Medical College and Hospital Bagalkot 587101  Shalyatantra OPD Room No 03 BVVS Ayurved Medical College and Hospital Bagalkot
Bagalkot
KARNATAKA 
9960516461

pravinbirajadar2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS Ayurveda 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-picu, पिचु (Procedure Reference: Baishajaratnavali, Procedure details: Purvakarma- 1 Informed consent will be taken. 2 Collection of all the materials required for the procedure. 3 Patient will be advised for sitz bath with luke warm water for 15 minutes. 4 Patient will be asked to lie comfortably in the lithotomy position on the examination table 5 The Pichu will be soaked in Kajjalikodaya Malahara. Pradhana karma- 1 Patient will be asked to relax, take deep breaths and strain, then gently Pichu will be inserted into the anal canal. Paschata karma- 1 Patient will be advised to remove the Pichu after 3 hrs. 2 Patient will be advised to follow Pathya. )
(1) Medicine Name: Triphala, Reference: Astanga hridaya uttara tantra 13th chapter 14,15 sloka, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: hs, Duration: 10 Days
2Comparator ArmProcedure-picu, पिचु (Procedure Reference: Astanga hridaya , Procedure details: Purvakarma- 1 Informed consent will be taken. 2 Collection of all the materials required for the procedure. 3 Patient will be advised for sitz bath with luke warm water for 15 minutes. 4 Patient will be asked to lie comfortably in the lithotomy position on the examination table 5 The Pichu will be soaked in Jatyadi Ghritha Pradhana karma- 1 Patient will be asked to relax, take deep breaths and strain, then gently Pichu will be inserted into the anal canal. Paschata karma- 1 Patient will be advised to remove the Pichu after 3 hrs. 2 Patient will be advised to follow Pathya. )
(1) Medicine Name: Triphala , Reference: Astanga hridaya ,Uttara tantra 13th chapter 14,15 sloka, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: hs, Duration: 10 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients diagnosed with parikartika are selected.
2.Patients aged between 18 – 60 years of either gender.
 
 
ExclusionCriteria 
Details  1 Patients diagnosed with other co-existing Ano rectal diseases, like hemorrhoids, fistula-in-ano, Ca rectum etc.
2 Patients of chronic fissure -in- ano with sentinel pile.
3 Patients with uncontrolled diabetes and hypertension.
4 Fissure-in-ano due to systemic disorders like ulcerative colitis, Crohns disease etc.
5 Patients suffering from infectious diseases, like RVD, Syphilis, HbsAg etc.
 
 
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

 
18 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the size of ulcer

 
18 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)   12/08/2024 
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  

 Parikartika is one among the ano-rectal disorders and is one of the complications of Basti and Virechana Karma as mentioned in classics. Parikartika is characterized by Kartanavat and Chedanavat Shoola, Daha in Guda. associated with Vibhanda, Anilasanga and Nabheradhorujam. It is caused by Sthana Samshraya of vitiated Vata and Pitta Doshas in Gudapradesha. It can be correlated with fissure-in-ano of the contemporary science.

   Anal fissure is longitudinal split in anoderm of the distal anal canal, which extends from the anal verge proximally towards but not beyond the dentate line.It is characterized by severe pain and burning sensation during and after defecation, severe constipation, and there is a drop of blood or streak of fresh blood on stool.

Fissure-in-ano occurs most commonly in midline posteriorly, in males usually posteriorly 95%, anteriorly 5%, and in females posteriorly 80%, and 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 and women and is common in all age group especially age group of 15-40 years. The incident is supposed to be high in one who passes hard and dry stool.

  The line of management in contemporary science is said to be conservative treatment and surgical intervention. The conservative treatment includes analgesics, stool softeners, soothing ointments and anal dilatation where as surgical intervention includes Lord’s dilation, posterior fissurectomy and lateral anal sphincterotomy. 

 In the Chikitsa of Parikartika, Acharyas have mentioned Madhura, Kashaya Rasa, Sneha Yukta Dravyas in the form of Pichu, Varti and Lepa which pacifies Vata and Pitta Doshas.

              Parikartika is considered as Sadyovrana, Acharya Sushruta has mentioned Pichu Prayoga in the context of Shashti Upakrama in the management of Vrana. Pichu is a treatment modality in which drug delivery increases by the contact time between the tissue and drug and as it increases the bioavailability of drug, Hence there will be early reduction of symptoms and ulcer takes less time to heal.

              Kajjalikodaya Malahara is mentioned in Bhaishajaratnavali is having properties like Lekhana, Krimigna, Shodhana and Ropana, It acts as Vranashodhaka and Vranaropaka, so it has been selected in the treatment of Parikartika.

              Jatyadi Ghrita is having properties like Tridoshahara, Lekhana, Shodhana and Ropana,    which acts as Vedanahara, Vranashodhaka and Vranaropaka.

Hence the present study is undertaken to evaluate and compare the efficacy of Kajjalikodaya Malahara Pichu and Jatyadi Ghrita Pichu in the management of Parikartika with special reference to Acute Fissure-in-Ano.

 
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