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CTRI Number  CTRI/2025/02/081429 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of ayurveda in the management of urticaria(Sheetapitta) 
Scientific Title of Study   Efficacy of Virechana Karma Followed by Vishaghna Mahakashaya Siddha Yoga Basti in the Management of Sheetapitta W.S.R. to Urticaria:An Open Labelled Randomized Standard Controlled Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Omkumari Kumre 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Panchakarma,4th floor,Institute of Teaching and Research in Ayurveda Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9039832948  
Fax    
Email  omeekumre870@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha G Tank 
Designation  Reader 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Panchakarma,4th floor,Institute of Teaching and Research in Ayurveda Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9825391284  
Fax    
Email  neha@itra.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Neha G Tank 
Designation  Reader 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Department of Panchakarma,4th floor,Institute of Teaching and Research in Ayurveda Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9825391284  
Fax    
Email  neha@itra.edu.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, opp. B division police station, Gurudwara road, Jamnagar-361008  
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda 
Address  Opp. B-Division Police Station,Gurudwara Road,Jamnagar,Gujarat 361008  
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 Omkumari Kumre  PG Hospital,Institute of Teaching and Research in Ayurveda  OPD No B-12, Panchakarma department
Jamnagar
GUJARAT 		 9039832948

omeekumre870@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Institute of Teaching and Research in Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L500||Allergic urticaria. Ayurveda Condition: SITAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Bhavaprakash samhita, Procedure details: Deepan Pachana with Trikatu Churna (3-5gm) with lukewarm water for 4-5days Snehapan with Go Ghrita for 3-7days Sarvanga Abhyanga with Bala Taila and Sarvanga Bashpa Swedana for 4 days Virechana Karma with Triphala kwatha,Pippali,and Erand taila Samsarjana Karma as per Suddhi Vishaghna Mahakashaya Siddha Yoga Basti for 8 days )
(1) Medicine Name: Triphala ,pippali, erand taila, Reference: Bhavaprakash Samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days
(2) Medicine Name: Vishaghna Mahakashya Siddha Yoga Basti, Reference: Charak Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 600(ml), Frequency: od, Duration: 3 Days
(3) Medicine Name: Vishaghna Mahakashya Siddha Yoga Basti, Reference: Charak Samhita, Route: Rectal, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 5 Days
2Comparator Arm (Non Ayurveda)-Tab CetrizineTab Cetrizine is antihistaminic agent will be given in the dose of 10mg BD after meals for 25 days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Willing and able to participate in the study Patient having eruption alone with any 2 or more symptoms of sheetapitta mentioned in diagnostic criteria and having Chronicity of disease less than or equal to 2 years yogya for Virechana Karma and Basti Karma as per Ayurvedic Classics 
 
ExclusionCriteria 
Details  Patients of age group less than 20 years and above 60 years Disease like uncontrolled Diabetes mellitus, hypertension, heart disease or other systemic illness Pregnent and lactating women Patients Ayogya for Virechana and Basti Karma Having chronicity more than 2 years 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It is expected that trial protocol will provide relief in sign and symptoms of Sheetapitta(Urticaria) It may bring changes in the level of IgE, AEC, ESR   Group-A 25-30 days
Group-B 25-30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Urticaria activity score UAS7  Group-A 25-30 days
Group-B 25-30 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   Phase 3 
Date of First Enrollment (India)   01/05/2025 
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="20" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Introduction:

Ayurveda explain a variety of skin disease caused by various causative factors amongst which the most common being Asatmya Sevana. Sheetapitta is a skin condition caused by exposure to allergens but the exact pathology is not known. It may be caused by a prolonged intake of Asatma Ahara. Sheetapitta is vaatika predominance along with Kapha and Pitta has Sheeta Maruta Sparsha as causative factor. We generally co-relate it with Urticaria. The word Urticaria is derived from latin word urtica which means stinging nettle. A transient redness and swelling of skin with itching, causing wheals in dermis or large hypo-dermal swelling, is called urticaria. The physical symptoms, urticaria can also have a  significant impact on patients quality of life, affecting and psychological well-being.


Significance:

Urticaria present a significant global health challenges dur to its sudden onset and potential for allergic reactions. The worldwide incidence is 0.1%-3% of the population with women affected twice more likely than men. It is estimated that about 1 in 5 people will have urticaria once in their lifetime and this seems to be the case across all age groups. Up to 1% of the population suffer from chronic urticaria and all age groups appear to be affected, although the peak incidence in between 20 and 40 years of age.

Aims and Objective

To asses and evaluate the effect of Virechana karma followed by Vishaghna Mahakashaya Siddha Yoga Basti in management of Sheetapitta w.s.r. to urticaria.

Material and Methods: 

40 Diagnosed and newly diagnosed patients of urticaria will be enrolled in two groups. Group A Patients will receive intervention with Virechana Karma Followed by Vishaghna Mahakashaya Siddha Yoga Basti. Group B patients will receive Standard drug (Tab. Cetrizine).

Result and Discussion:

Data generated during the above study will be present in a systemic manner as shall be analyzed statically. Where the important points of the Conceptual study, Analytical Study, Pharmacological Study will be discussed.

Follow up:

After completion of therapy, follow up will be done after 4 weeks to assess the status of patients, where patients will be asked to report.

Adverse effect:

This drug have no known unwanted effect. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.







 
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