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CTRI Number  CTRI/2024/03/064902 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 24/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Khadira Siddha Ghrita With Shatadhaut Ghrita In The Management Of Parikartika for 07 days. 
Scientific Title of Study   Randomised Controlled Study To Evaluate The Efficacy Of Khadira Siddha Ghrita With Shatadhaut Ghrita In The Management Of Parikartika For 07 Days. 
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 Akshay Kashinath Sirsat 
Designation  P.G Scholar Shalyatantra 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 411028 
Address  MAMs Sumatibhai Shah Ayurved College , Shalyatantra Department Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra

Pune
MAHARASHTRA
411028
India 
Phone  8766497991  
Fax    
Email  aksirsat9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Dnandeo Narkhede 
Designation  Assistant professor  
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 411028 
Address  MAMs Sumatibhai Shah Ayurved College , Shalyatantra Department Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra

Pune
MAHARASHTRA
411028
India 
Phone  9850200998  
Fax    
Email  sanjeevanihospitalpune@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yogesh Dnandeo Narkhede 
Designation  Assistant professor  
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 411028 
Address  MAMs Sumatibhai Shah Ayurved College , Shalyatantra Department Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra

Pune
MAHARASHTRA
411028
India 
Phone  9850200998  
Fax    
Email  sanjeevanihospitalpune@rediffmail.com  
 
Source of Monetary or Material Support  
Sane Guruji Arogya Kendra Malwadi Hadapsar  
 
Primary Sponsor  
Name  Dr Akshay Kashinath Sirsat 
Address  MAMs Sumatibhai Shah Ayurved College , Shalyatantra Department Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra 
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 Akshay Kashinath Sirsat  Sane Guruji Arogya Kendra  OPD No. 3 Shalyatantra Department
Pune
MAHARASHTRA 		 08766497991

aksirsat9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee MAMs Sumatibhai Shah Ayurved Mahavidyalay & Sane guruji arogya kendra Hadapsar Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Khadira Siddha Grita , Reference: Bhavprakash 10, Route: Topical, Dosage Form: Ghrita, Dose: 4(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Shatadhaut grita, Reference: Charak samhita, Route: Topical, Dosage Form: Ghrita, Dose: 4(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patient having clinical sign and symptoms of Parikartika.
2)Patient diagnosed as having Parikartika (Fissure-in-ano)
3) Irrespective of gender between the age group of 19-60 yr.
4) Per rectal bleeding with cutting pain at anal region.
5)Burning at Anal region.
 
 
ExclusionCriteria 
Details  1)Known case of Ulcerative colitis, Chrohn’s disease, Syphilis, and
Tuberculosis.
2)Patient suffering from Malignancy of any organ or ano-rectum will
be excluded.
3)K/C/O HIV and HBsAg, VDRL will be excluded.
4)Uncontrolled cases of DM and Hypertension will be excluded 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Khadira siddha Ghrita in the management of Parikartika  In 07 days 
 
Secondary Outcome  
Outcome  TimePoints 
To Observe the Efficacy of Khadira siddha Ghrita with Shatdhaut Ghrita in the management of Parikartika  In 07 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 4 
Date of First Enrollment (India)   10/04/2024 
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="11"
Days="30" 
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 considered as one of the most painful condition of analcanal . Affecting Majority of population in todays modern era due to changing lifestyle. This study plan to asses efficacy of Khadira siddha ghrita and Shatdhauta ghrita in the management of parrikartika. 
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