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CTRI Number  CTRI/2025/06/088281 [Registered on: 05/06/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Treatment of skin disease with symptoms such as skin rash, itching, burning sensation, fever etc ,using Ayurveda formulations  
Scientific Title of Study   An Open Label Single Arm Clinical Study to Evaluate the Combined effect of Sadhyovamana, Gudadeepyaka and Nishottamadi Kashaya in the management of Sheetapitta vis-a-vis Urticaria. 
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 Megha M Pujari 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital Mysuru  
Address  Dr Megha M Pujari PG Scholar Dept of Kayachikitsa opd number 10 Government Ayurveda Medical College and Hospital New Sayyaji rao road near Vishweshwaraya Circle Mysuru Karnataka 570001

Mysore
KARNATAKA
570001
India 
Phone  8073585007  
Fax    
Email  meghampujari542@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mythrey R C  
Designation  Professor and Head 
Affiliation  Government Ayurveda Medical College and Hospital Mysuru 
Address  Dept of Kayachikitsa opd number 10 Government Ayurveda Medical College and Hospital New Sayyaji rao road near Vishweshwaraya Circle Mysuru Karnataka 570001

Mysore
KARNATAKA
570001
India 
Phone  9513199733  
Fax    
Email  mythreyrc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Megha M Pujari 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital Mysuru  
Address  Dr Megha M Pujari PG Scholar Dept of Kayachikitsa opd number 10 Government Ayurveda Medical College and Hospital New Sayyaji rao road near Vishweshwaraya Circle Mysuru Karnataka 570001

Mysore
KARNATAKA
570001
India 
Phone  8073585007  
Fax    
Email  meghampujari542@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital Vishweshwaraya circle Mysuru Karnataka 570001 
 
Primary Sponsor  
Name  Dr Megha M Pujari  
Address  Dr Megha M Pujari PG Scholar Dept of Kayachikitsa opd number 10 Government Ayurveda Medical College and Hospital New Sayyaji rao road near Vishweshwaraya Circle Mysuru Karnataka 570001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Megha M Pujari  Government Ayurveda Hi Tech panchakarma Hospital   OPD division Ground floor Brindhavan extension 1st stage Brindhavan extension Mysuru 570016
Mysore
KARNATAKA 
08073585007

meghampujari542@gmail.com 
Dr Megha M Pujari  Government Ayurveda Medical College and Hospital   Dept of Kayachikitsa opd number 10 Government Ayurveda Medical College New Sayyaji rao road near Vishweshwaraya Circle Mysuru Karnataka 570001
Mysore
KARNATAKA 
08073585007

meghampujari542@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurveda Medical College and Hospital Institutional Ethical Clearance Committee Mysuru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: SITAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gudadeepyaka, Reference: Bhava prakasha madyama khanda , Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Sukoshna jala), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Nishottamadi kashaya, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: -
3Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Vangasena Samhita, Procedure details: The subject undergoes Abhyanga and Swedana, followed by Akhanta Pana. Then, a kwatha is given as the Vamaka dravya, followed by administration of Vamanopaga dravya.)
(1) Medicine Name: Patola,nimba and vasa, Reference: Vangasena Samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Subjects of all gender of age group between 18 to 50 years.
2.Subjects with the signs and symptoms of Sheetapitta vis-à-vis Urticaria will be included.
3. Subjects with Urticaria Activity score - UAS 1-6 will be included.
4. Both fresh cases and treated cases of Sheetapitta vis-à-vis Urticaria will be included.

 
 
ExclusionCriteria 
Details  1. Subjects diagnosed with Urticarial vasculitis, Tuberculosis, HIV, Viral infections, Carcinoma and other Skin infections will be excluded.
2. Subjects with Uncontrolled Diabetes Mellitus, Uncontrolled Hypertension, Renal disorders and or other systemic illness which might interfere with the course of treatment will be excluded.
3. Pregnant women and lactating mother will be excluded.
4. Subjects unfit for Sadhyovamana procedure will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of signs and symptoms like varatidamshtravat shotha, kandu, toda, daha, chardi, jwara.  0th day,3rd day, 31st day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvememt in the scores of Urticaria Activity Score.  0th day,3rd day, 31st day 
 
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/ Phase 3 
Date of First Enrollment (India)   15/06/2025 
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="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  
Sheetapitta is a Tridoshaja Vyadhi (disease caused by the vitiation of all three doshas—Vata, Pitta, and Kapha) that manifests on the skin and affects individuals of all age groups. It is typically triggered by exposure to cold air or breeze, which aggravates Vata and Kapha doshas. These doshas then associate with Pitta dosha, resulting in various symptoms such as Varatidamshtravat Shotha (swelling resembling an insect bite), Kandu (itching), Toda (pricking pain), Daha (burning sensation), Chardi (vomiting), and Jwara (fever). Classical Ayurvedic texts like those of Madhavakara consider Sheetapitta and Udarda to be synonymous. The clinical features of Sheetapitta closely resemble those of urticaria.
Urticaria, in contemporary medicine, presents as transient skin lesions characterized by a central wheal surrounded by an erythematous halo or flare. These lesions are often pruritic (itchy) and typically last for about 24 hours. Urticaria is categorized as acute if it persists for less than six weeks and chronic if it continues for more than six weeks. It is a common condition, affecting approximately 15–20% of the population at some point in their lives. The peak incidence is observed during the third decade of life, and the condition tends to be more prevalent in females than in males.
According to Ayurveda, Sheetapitta (urticaria) requires immediate treatment due to its sudden onset. Sadhyovamana, a rapid cleansing procedure, is used without prior preparation to eliminate aggravated Kapha. Treatments like Abhyanga, Seka, Vamana, Virechana, Lepa, and Shamanoushadi are recommended, along with protocols for Kushta and Amlapitta. Gudadeepyaka, containing Pittaghna Guda and Kaphavatagna Ajamoda, and Nishottamadi Kashaya, indicated for skin disorders, may support effective management. This study evaluates the combined efficacy of Sadhyovamana, Gudadeepyaka, and Nishottamadi Kashaya in treating Sheetapitta.
 
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