| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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: - | | 3 | Intervention Arm | Procedure | - | 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 |
|
|
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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. |
|
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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 |
|
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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. |