| CTRI Number |
CTRI/2025/04/084915 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Atopic dermatitis in children by using Kukkiladhi chooranam and Milagu ennai |
|
Scientific Title of Study
|
An Open Clinical trial to evaluate the effectiveness of Kukkiladhi chooranam (Internal medicine) and Milagu ennai (External medicine) in the management of Karappan (Atopic dermatitis) in children among outpatients attending Ayothidoss Pandithar Hospital, National Institute of Siddha |
| 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 J Reena |
| Designation |
Postgraduate Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9944381097 |
| Fax |
|
| Email |
reenajayaraman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Meenakshi Sundaram |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Meenakshi Sundaram |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium
Chennai-600047
Kancheepuram district |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 J Reena |
National Institute of Siddha |
Room no 16/17,Department of Kuzhandhai Maruthuvam,National Institute of Siddha, Tambaram Sanatorium, Chennai-600047
Kancheepuram
TAMIL NADU |
9944381097
reenajayaraman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Siddha, |
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 |
| Intervention |
Kukkiladhi chooranam (Internal medicine)
Milagu ennai (External medicine) |
Internal medicine:
1.Kukkiladhi chooranam
Dosage: Mooviral alavu(800-1000 mg)
3-5 years:300 mg,Bd
6-8 years:400 mg,Bd
9-12 years:500 mg,Bd
vehicle:Luke warm water
Duration:48 days
Route of administration: Oral
External medicine:
Milagu ennai
Topical application, required quantity
Duration:48 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of both sex in the age group of 3 to 12 years with symptoms according to EASI Score:
1.Erythema
2.Oedema
3.Oozing
4.Itching
5.Crusting
6.Scaling
7.Lichenified plaques |
|
| ExclusionCriteria |
| Details |
1.K/C/O Scabies
2.K/C/O Contact dermatitis
3.K/C/O Seborrheic Dermatitis
4.K/C/O Psoriasis
5.K/C/O Secondary Bacterial Infections
6.K/C/O Furunculosis
7.K/C/O Neurodermatitis
8.Any other serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of the trial drug will be measured by using EASI score before and after treatment |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The characteristics of the trial drug Kukkiladhi chooranam will be analysed as per PLIM guidelines
2.The characteristics of the trial drug Milagu ennai will be analysed as per PLIM guidelines |
1 month |
|
|
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 |
|
Date of First Enrollment (India)
|
30/05/2025 |
| 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="0"
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
|
Introduction: As per the Siddha literature, Karappan is associated with the symptoms of erythema, oedema, intense pruritis, exudation, crusting and scaling. In the textbook of Kuzhandhai Maruthuvam (Balavagadam), the signs and symptoms of Karappan described are nearly correlated with the signs and symptoms of Atopic dermatitis. Atopic dermatitis (AD) or Eczema, is mainly a disease of childhood. Childhood- onset AD begins early in life, with 50% diagnosed in the first year of life and 85% by 5 years of age. In the textbook of Udal thathuvam the humoral changes of Karappan is quoted as “Iruthirogam karappan viranathodam”. From this it is clear Kabam humor is increased in this disease. Taste such as karppu (pungent), kaippu (bitter), thuvarppu (astringent) are said to balance the kabam humor. Most of the ingredients in Kukkiladhi chooranam and Milagu ennai have karppu (pungent), kaippu (bitter) taste which help in decreasing the kaba humor.
Materials and methods: An open Clinical trial will be conducted in Kuzhandhai Maruthuvam OPD of Ayothidoss Pandithar hospital, National Institute of Siddha, Tambaram Sanatorium,Chennai-600047. A total of 30 children (male and female) aged 3 to 12 years of age diagnosed with Atopic dermatitis (Karappan) and who are willing to participate in the trial by signing consent form and assent form will be enrolled based on inclusion and exclusion criteria. Kukkiladhi chooranam (Internal medicine) and Milagu ennai (External medicine) will be given for a duration of 48 days.
Results: Effectiveness of the trial drug will be measured by using EASI Score before and after treatment.
Keywords: karappan, Atopic dermatitis, Kukkiladhi chooranam, Milagu ennai |