| CTRI Number |
CTRI/2025/02/080785 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Oma ilagam (Internal)and Kunthirika Thylam ( External)
in the management of Kaanakadi(Urticaria) |
|
Scientific Title of Study
|
An open clinical Trial to evaluate the Effectiveness of Siddha formulation Oma Ilagam(Internal Medicine) and Kunthirika Thylam( External Medicine) in the management of Kaanakadi(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 Dharmar M |
| Designation |
Post Graduate Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 26 27
Department of Nanju Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
7708239711 |
| Fax |
|
| Email |
dharmard591@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Madhavan |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 26 27
Department of Nanju Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
9965561656 |
| Fax |
|
| Email |
drmadhavanji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmar M |
| Designation |
Post Graduate Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 26 27
Department of Nanju Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
7708239711 |
| Fax |
|
| Email |
dharmard591@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram sanatorium
Chennai 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room No 26 27
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 Dharmar M |
Ayothidoss Pandithar Hospital |
Room No 26 27
Department Of Nanju Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai 47
Chennai
TAMIL NADU |
7708239711
dharmard591@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L50||Urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Oma Ilagam(Internal) and Kunthirika Thylam(External) |
Internal 5g bid with hot water after food external medicine apply on the affected area for 40days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Clinical diagnosis of erythematous wheal formation urticaria with UAS Score
patients willing and able to to provide informed consent and to comply with the study protocol
patients willing to stop using any treatment other than the investigational product for urticaria
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactation women
Evidence of any skin condition other than urticaria
Narcotic addicts and Angioneurotic oedema
Other medications or disease that might directly interfere in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the Trail Drug is measured using Urticaria Activity Score UAS |
Changes in the Urticaria Activity Score will be assessed before and after treatment along with blood parameters after 40 day of Trail Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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 3 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="1"
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
|
INTRODUCTION Urticaria is characterized by itching wheal formation angioedema and pruritus which may be localized or generalized in the body recurrently for at least 6 weeks Although the wheals can resolve within 24 hrs symptoms have a significant detrimental impact on the quality of life of this patients Kaanakadi occurs when the body reacts to an allergen and releases histamine and other chemicals from under the surface of the skin Kaanakdi is a type of inflammatory disorder In the siddha text Aathma Ratchamirtham OMA ILAGAM has indicated for soolai sirangu kuttam kiranthi pun and silvisham The main ingretients of the above medicine are well known for its anti histamine anti inflammatory anti oxidant and anti immunomodulatory activities In the text book of Siddha Formulary of india 1 KUNTHIRIKA THYLAM has specifically indicated for skin disease
AIM To evaluate the clinical effectiveness of siddha formulation OMA ILAGAM internal and KUNTHIRIKA THYLAM external in the management of KAANAKDI
OBJECTIVE To assess the changes in clinical symptoms by using Urticaria Activity Score UAS To assess the changes in clinical laboratory blood parameters such as IgE AEC CRP and ESR before and after treatment
STUDY TYPE Interventional study
STUDY DESIGN An Open Clinical Trial
OUTCOME OF STUDY Clinical effectiveness of Oma ilagam and Kunthirika thylam in the management of urticaria will be evaluated by significant reduction in clinical symptoms based on Urticaria Activity Score and clinical laboratory blood parameters before and after treatment |