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CTRI Number  CTRI/2021/03/031915 [Registered on: 11/03/2021] Trial Registered Prospectively
Last Modified On: 10/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   AYURVEDIC MANAGEMENT FOR SHEETAPITTA (URTICARIA) 
Scientific Title of Study   “A COMPARATIVE CLINICAL STUDY ON VIRECHANA AND SIRAVYADHA IN THE MANAGEMENT OF SHEETAPITTA W.S.R URTICARIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramya L 
Designation  PG Scholar  
Affiliation  Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal  
Address  Room no 05 , Department of panchakarma ,Shree Jagadguru Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal

Koppal
KARNATAKA
583231
India 
Phone  7848964077  
Fax    
Email  ramyaparichaya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjunath Akki  
Designation  Professor and Guide 
Affiliation  Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal  
Address  Room no 05 , Department of panchakarma ,Shree Jagadguru Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal

Koppal
KARNATAKA
583231
India 
Phone  8123044125   
Fax    
Email  drmanju78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjunath Akki  
Designation  Professor and Guide 
Affiliation  Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal  
Address  Room no 05 , Department of panchakarma ,Shree Jagadguru Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal

Koppal
KARNATAKA
583231
India 
Phone  8123044125   
Fax    
Email  drmanju78@gmail.com  
 
Source of Monetary or Material Support  
shree jagadguru gavisiddeshwara ayurvedic medical college and research center gavimutt koppal  
 
Primary Sponsor  
Name  Shree Jagadguru gavisidheswara ayurvedic medical college postgraduate studies and research centre  
Address  Room 05 DEPT Of Panchakarma Gavisiddeshwara Ayurvedic Madical College, Post Graduate Studies and Research Center. Koppal 583231 Karnataka Koppal KARNATAKA 583231 India  
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 
Dr Ramya L  Shree Jagadguru gavisidheswara ayurvedic medical college postgraduate studies and research centre  Room 05 ,Department of panchakarma ,Shree Jagadguru gavisidheswara ayurvedic medical college postgraduate studies and research centre Koppal Koppal KARNATAKA
Koppal
KARNATAKA 
7848964077

ramyaparichaya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL CLINICAL ETHICAL COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: SITAPITTAM,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Siravyadha  sadyo sneha with Mahatiktakaghrita orally 70ml , followed by siravyadha with scalp vein set 
Intervention  Virechana with Triphaladi kwatha  Virechana kashaya orally dose- 80ml once , snehapana with Mahatiktaka Ghrita orally 1st day -30ml, 2nd day -60ml ,3rd day -90ml 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1 Patient fulfilling the diagnostic criteria
2 Patients between the age group of 15 to 45 years of either sex
3 Patients who are fit for Virechana and Siravyadha Karma
4 Patients suffering with Sheetapitta for more than 6 weeks to 10 years.
 
 
ExclusionCriteria 
Details  1 Patients with other systemic disorder which interfere with the course of the treatment
2 Rashes and other symptoms which is produced by insect bite
3 Sheetapitta of acute onset.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
absence of Varatidamstrasamsthanasotha ( Rashes like insect bite mark),Toda (Pricking Pain),Daha (burning sensation ),Kandu (itching sensation )
 
28 days 
 
Secondary Outcome  
Outcome  TimePoints 
complete absence of absence of Varatidamstrasamsthanasotha ( Rashes like insect bite mark),Toda (Pricking Pain),Daha (burning sensation ),Kandu (itching sensation )
absence of Varatidamstrasamsthanasotha ( Rashes like insect bite mark),Toda (Pricking Pain),Daha (burning sensation ),Kandu (itching 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 2 
Date of First Enrollment (India)   15/03/2021 
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="0"
Months="3"
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 - NO
Brief Summary  

Sheetapitta is one among the skin disease, and it is Vatapradhanavyadhi. Hence the pain is more in Sheetapitta and produces symptoms like rashes as like of insect bite, itching sensation…etc.1

According to Classical references, Sheetapitta is having sign and symptoms as VaratiDamstraSamsthana (rashes like insect bite),Shopha (papular rashes) ,Kandu (itching), Toda (pricking pain) …etc.2 3

              As mentioned in classics, nidanas are exposure to cold wind, Vega Avrodha and other factors which causes vitiation of Kapha and Vata, which in turn vitiates Pitta ,Rakta and produces rash on the skin which is called as Sheetapitta.4

Sheetapitta is the commonest disease which occurs frequently with a life time; globally prevalence of the disease is around 8.8%.Usually prevalence is more in females than males. In terms of age 20-30 year old are more affected by the disease. In India 20 to 30% population are suffering from this disease.5

Sheetapitta can be correlated to Urticaria and it is characterized by a sudden general eruption of pale wheals or papules, which are associated with severe itching, and it is caused due to contact with external irritants such as nettle, physical agents, foods, insects bites, serum sickness, pollens, drugs, milk, egg, meat etc.6

        In classical texts they have mentioned number of treatments for Sheetapitta like Abhyanga, Swedana,Vamana, Virechana and Raktamokshana, among them Virechana  subsides theVititatedVata ,Pitta, Kapha  by eliminating doshas through anal route and does the Raktashodhana and  KostaShuddi. In Siravyadha it does RaktaShodhna by removing DushitaRakta by vein puncture .7 8

                            The present study intends to evaluate the comparative effect of Virechana and Siravyadha in the Management of Sheetapitta. 
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