| CTRI Number |
CTRI/2026/02/104110 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Peichori Kudineer(Internal) and Sainthavaathi Lebanam(External) for the treatment of SEETHAPITHAM (URTICARIA) in the Paediatric age group. |
|
Scientific Title of Study
|
A Preclinical and double-arm clinical Study to evaluate the Therapeutic efficacy of PEICHORI
KUDINEER (Internal) and SAINTHAVAATHI LEBANAM (External) in the Management of SEETHA PITHAM(URTICARIA) in the Paediatric age group. |
| 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 Y S SHILPAASHRI |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
PG Second Year,Department of Kuzhanthai Maruthuvam,Government siddha Medical College and Hospital,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486993446 |
| Fax |
|
| Email |
shriyuvaraj23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A ANBUMALAR MD S |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,Government siddha Medical College and Hospital,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788232433 |
| Fax |
|
| Email |
anbumalara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A ANBUMALAR MD S |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788232433 |
| Fax |
|
| Email |
anbumalara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital Palayamkottai,Tirunelveli 627002 |
|
|
Primary Sponsor
|
| Name |
Dr Y S SHILPAASHRI |
| Address |
PG Second Year,Department of Kuzhanthai Maruthuvam,Government siddha Medical College and Hospital,Palayamkottai 627002 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Y S SHILPAASHRI |
Government Siddha Medical College and Hospital,Palayamkottai |
Department of Kuzhanthai Maruthuvam,Government siddha Medical College and Hospital,Palayamkottai-627002
Tirunelveli
TAMIL NADU |
9486993446
shriyuvaraj23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE 2024 2027 GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L500||Allergic urticaria, (2) ICD-10 Condition: L508||Other urticaria, (3) ICD-10 Condition: L509||Urticaria, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PEICHORI KUDINEER (Internal) |
Should Be Administered Orally Twice a day After Food Dosage
(According to age group and body weight)3-12 years- 15-30ml. Duration 7 days. |
| Comparator Agent |
SAINTHAVAATHI LEBANAM (External) |
Topical application - Should be applied externally Duration 7 days. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Urticaria symptoms like wheals,redness,pruritus,
Allergic reactions which includes Foods,vegetable spices,and fruits
Medications
plants
Food preservatives
Industrial materials
physical stimuli
Insect bite/stings
|
|
| ExclusionCriteria |
| Details |
Children below 2 years and above 12 years
Auto immune cause
Mastocytosis
Stills disease
Atopic dermatitis
Infection induced urticaria
Erythema multiforme |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is expected to prove the safety and efficacy of Peichori Kudineer and Sainthavaathi Lebanam in children with Seethapitham, showing relief in itching, redness, wheals, reduced recurrence, and evidence-based Siddha validation. |
The Study Outcomes Including Symptomatic Relief (Reduction in itching,wheals,erythema)Reduction in recurrence and Improvement in quality of life,Will be asessed at predefined time intervals-At Baseline(Day0),During Treatment(Day3) and at the end of Treatment (1 Week)-to evaluate the safety and Therapeutic efficacy of PeichoriKudineer(Internal)and Sainthavaathi Lebanam(External)in the management of Seethapitham (Urticaria) in the Paediatric age group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="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
|
BACKGROUND:
This study is planned as a preclinical and double-arm clinical study to evaluate the therapeutic efficacy and safety of Peichori Kudineer (internal) and Sainthavaathi Lebanam (external) in the management of Seetha Pitham (urticaria) in children. The preclinical phase will assess the safety profile of the study drugs, while the clinical phase will include paediatric patients diagnosed with Seetha Pitham. Efficacy will be evaluated based on improvement in urticarial symptoms such as wheals, pruritus, duration, and recurrence, along with safety assessment through clinical monitoring. The study aims to generate scientific evidence for the use of Siddha internal and external medicines in paediatric urticaria. |