| CTRI Number |
CTRI/2025/11/097162 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Long Pepper and Garlic in spray dryied Milk powder form for the management of Urticaria/Sheethapitha |
|
Scientific Title of Study
|
A randomized controlled trail comparing the clinical efficacy of Ksheerapaka preparation of Vardhamana Pippali and Vardhamana Lasuna in Choorna form for the management of Sheethapitha |
| 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 Sruthi o |
| Designation |
Phd Scholar |
| Affiliation |
Shree Swaminarayan Ayurvedic college |
| Address |
Shree Swaminarayan Ayurvedic college
Kalol Gujarat382725
Shree Swaminarayan Ayurvedic college, Kalol, Gujarat 382725
Gandhinagar
GUJARAT
382725
India |
| Phone |
8946086035 |
| Fax |
|
| Email |
dr.sruthi.sreedhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Tapan Vaidya |
| Designation |
Professor, Department of Kayachikitsa |
| Affiliation |
Shree Swaminarayan Ayurvedic college |
| Address |
Shree Swaminarayan Ayurvedic college
Kalol Gujarat 382725
Shree Swaminarayan Ayurvedic college
Kalol Gujarat 382725
Gandhinagar
GUJARAT
382725
India |
| Phone |
9924304388 |
| Fax |
|
| Email |
Vdtapan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sruthi o |
| Designation |
Phd Scholar |
| Affiliation |
Shree Swaminarayan Ayurvedic college |
| Address |
Shree Swaminarayan Ayurvedic college
Kalol Gujarat 382725
Shree Swaminarayan Ayurvedic college Kalol Gujarat 382725
Gandhinagar
GUJARAT
382725
India |
| Phone |
8946086035 |
| Fax |
|
| Email |
dr.sruthi.sreedhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Swaminarayan Ayurvedic college, Kalol, Gujarat 382725 ,India |
|
|
Primary Sponsor
|
| Name |
Shree Swaminarayan Ayurvedic college |
| Address |
Shree Swaminarayan Ayurvedic college Kalol Gandhinagar Gujarat ,382725,India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kayachikitsa department Shree Swaminarayan Ayurvedic college |
Shree Swaminarayan Ayurvedic college Kalol Gandhinagar Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Tapan vaidya |
Shree Swaminarayan Ayurvedic college |
Kayachikitsa Department
Gandhinagar
GUJARAT |
9924304388
vdtapan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MD Ayurveda College Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L50||Urticaria. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients with classical symptoms of Ksheethapitha |
|
| ExclusionCriteria |
| Details |
Patients with other skin diseased like Atopic dermatitis, Contact dermatitis, Drug eruptions, Scabies.
Emergency conditions like Angioedema.
Pregnant and lactating women.
Patients with autoimmune conditions like SLE. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urticarial activities Score 7 |
Base line zero ,2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dermatology Life Quality Index
VAS |
2 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2026 |
| 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="3"
Months="0"
Days="0" |
|
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
|
The present clinical trial aims to evaluate the efficacy of Ksheerapaka preparations of Vardhamana Pippali and Vardhamana Lasuna in Choorna form for the management of Sheetapitha. The study will be conducted as an open-labeled, randomized, parallel-group trial. Eligible participants will be divided into two groups and will receive the respective Choorna in an increasing (Vardhamana) dosage pattern as per classical Ayurvedic references for a specific duration of 14 days. Clinical symptoms and laboratory investigations will be assessed before and after the treatment. The results of this study may provide scientific evidence for the traditional Vardhamana therapy as a potential Ayurvedic approach for the management of Sheetapitha. |