FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056695 [Registered on: 21/08/2023] Trial Registered Prospectively
Last Modified On: 14/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial on effectiveness of karaskara grita pichu in the management of parikartika (Acute fissure in ano) 
Scientific Title of Study   Clinical study on effectiveness of karaskara grita pichu in the management of parikartika (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 Shivnesh S  
Designation  Pg scholar Deptartment of Shalya Tantra 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan  
Address  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  7708601448  
Fax    
Email  shivsenthil154@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopikrishna B J 
Designation  Professor And Hod Deptartment of Shalya Tantra 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan  
Address  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9886360901  
Fax    
Email  drgopiboyapati@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gopikrishna B J 
Designation  Professor And Hod Deptartment of Shalya Tantra 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan  
Address  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9886360901  
Fax    
Email  drgopiboyapati@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan, Karnataka 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan  
Address  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 India  
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 Shivnesh S  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan  SHALYA ARC OPD NO 11 DEPARTMENT OF SHALYA TANTA SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN
Hassan
KARNATAKA 		 7708601448

shivsenthil154@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, Sri Dharmasthala College of Ayurveda and Hospital, BM 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:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-picu, पिचु (Procedure Reference: Chikitsa manjari, Procedure details: Local application of Karaskara Gritha in a dosage of 1 gm in a gauze piece over Acute fissure in ano.)
(1) Medicine Name: Haritaki, Reference: Charaka samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Duration: 28 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Participants suffering from Acute Fissure in Ano
2.Participants of either Gender
3.Participants age group between 18-70 Years
4.Participants willing to participate and sign the informed consent form. 
 
ExclusionCriteria 
Details  1.Participants with K/C/O Ulcerative colitis, Crohn’s disease, Tuberculosis
2.Participants with Carcinoma of rectum & anal canal
3.Participants with other systemic illness like diabetes mellitus (HbA1c > 8%), Human Immunodeficiency Virus and Hepatitis B positive Participants.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in
1. Size of ulcer
2. Sphincter tone
3. Ulcer healing 		 28 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in
1. Pain
2. Constipation
3. Bleeding
4. Burning sensation  		 28 days  
 
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 3 
Date of First Enrollment (India)   24/08/2023 
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="2"
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 a very common disease and most painful disease occurring in Ano-rectal region in day today life.Karaskara Ghrita is selected as they are having effective Vrana Ropana and Vrana Shodhana, Shoolahara property and Ghrita is Tridoshahara and has good lubricating action, also Ghrita helps in relieving Daha, on this basis attempt is made to evaluate the efficacy of Karaskara Ghrita Pichu in management of Parikartika with special reference to Acute Fissure-in-ano.

 
Close