| CTRI Number |
CTRI/2025/01/079272 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study on PATTAI RASAYANAM and SIRUTHETKODUKKU THYLAM in the treatment of SATTAI KARAPPAN in children |
|
Scientific Title of Study
|
Preclinical and clinical evaluation of PATTAI RASAYANAM (INTERNAL) and PATTAI RASAYANAM (INTERNAL) with SIRUTHETKODUKKU THYLAM (EXTERNAL) in the management of SATTAI KARAPPAN (ATOPIC DERMATITIS) in children - A double arm study |
| 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 K Jagadeeswari |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli |
| Address |
PG First Year, Department Of Kuzhanthai Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486415672 |
| Fax |
|
| Email |
jagadeeswari1805@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Geetha Devi MD S |
| Designation |
Associate Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli |
| Address |
Department Of Kuzhanthai Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7401757475 |
| Fax |
|
| Email |
geethadevis16@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Geetha Devi MD S |
| Designation |
Associate Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli |
| Address |
Department Of Kuzhanthai Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7401757475 |
| Fax |
|
| Email |
geethadevis16@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002,Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
Dr K Jagadeeswari |
| Address |
PG Scholar First Year, Department Of Kuzhanthai Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002,Tamilnadu,India. |
| 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 K Jagadeeswari |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli |
Department Of Kuzhanthai Maruthuvam Branch IV, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU |
9486415672
jagadeeswari1805@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002,Tamilnadu,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PATTAI RASAYANAM (INTERNAL) with SIRUTHETKODUKKU THYLAM (EXTERNAL) |
Internal-Should be administered orally twice a day after food. Dosage(according to age group and body weight)3-12 years-1gms-3gms.Duration 48 days.
External-Topical application 2 times a day |
| Intervention |
PATTAI RASAYANAM(INTERNAL) |
Should be administered orally twice a day after food. Dosage (according to age group and body weight) 3-12 years- 1gms-3gms. Duration 48 days. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female children
Erythema
Pruritus
Oozing
Papules
Papulovesicles
Lichenification
Crusted lesions
|
|
| ExclusionCriteria |
| Details |
Children below 3 years
Children above 12 years
Scabies
Psoriasis
Other type of dermatitis
Dermatophytosis
Impetigo
Lichen Planus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study shows preclinical and clinical evaluation of PATTAI RASAYANAM(INTERNAL) or PATTAI RASAYANAM(INTERNAL) with SIRUTHETKODUKKU THYLAM (EXTERNAL) in the prognosis of SATTAI KARAPPAN (ATOPIC DERMATITIS) in Children in OPD of Government Siddha Medical College and Hospital Palayamkottai |
2 years |
|
|
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)
|
03/02/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
PRECLINICAL AND CLINICAL EVALUATION OF PATTAI RASAYANAM (INTERNAL) AND PATTAI RASAYANAM (INTERNAL) WITH SIRUTHETKODUKKU THYLAM (EXTERNAL) IN THE MANAGEMENT OF SATTAI KARAPPAN (ATOPIC DERMATITIS) IN CHILDREN-A DOUBLE ARM STUDY
BACKGROUND:
KARAPPAN is one of the types of Aga Karana Noigal which is mentioned in the Siddha text book BALAVAGADAM. Karappan is classified into 18 types and it mostly affects the age group of 7 to 12 years. I have chosen the topic SATTAI KARAPPAN as my dissertation. Siddha text book of BALAVAGADAM describes Sattai Karappan as a disease characterized by itching, papules, papulovesicles and crusted lesion. These symptoms are similar to the symptoms of Atopic Dermatitis mentioned in contemporary modern literature. Atopic dermatitis also called atopic eczema is a recurrent inflammatory skin disease and affects 15-20% of children and 1-3% of adults worldwide. It is characterized by acute flare-ups of eczematous prutitic lesions over dry skin. This study was designed to have a complete contemporary understanding of two different Siddha formulations PATTAI RASAYANAM (Internal) and SIRUTHETKODUKKU THYLAM (External) in the management of SATTAI KARAPPAN. OBJECTIVE: The objective of the study is to evaluate the therapeutic effectiveness of PATTAI RASAYANAM (Internal) and PATTAI RASAYANAM (Internal) with SIRUTHETKODUKKU THYLAM (External) in the management of SATTAI KARAPPAN (ATOPIC DERMATITIS) in children through clinical study. |