| CTRI Number |
CTRI/2025/02/080440 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Effectiveness ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An interventional study in which participants affected with Karappan Eczema will be treated with Gowri chindamani chendooram Internal and Karappan thylam External for the treatment of Karappan Eczema |
|
Scientific Title of Study
|
An Open Clinical Trial to evaluate the effectiveness of Siddha formulation Gowri Chinthamani Chendooram Internal and Karappan thylam External in the management of Karappan Eczema amoung outpatients attending Ayothidass Pandithar Hospital National Institute of Siddha Chennai 47 |
| 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 Yazhini S |
| Designation |
PG scholar |
| Affiliation |
National institute of siddha |
| Address |
Room no 26/27 Department of nanju maruthuvam National Institute of Siddha Tambaram sanitorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
07550001790 |
| Fax |
044-22381314 |
| Email |
yazhuyazhini1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Manjari |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 26/27 Department of nanju maruthuvam National Institute of Siddha Tambaram sanitorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8056903083 |
| Fax |
044-22381314 |
| Email |
drmanjarimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yazhini S |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 26/27 Department of nanju maruthuvam National Institute of Siddha Tambaram sanitorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
07550001790 |
| Fax |
044-22381314 |
| Email |
yazhuyazhini1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha, tambaram sanitorium,chennai- 47 |
|
|
Primary Sponsor
|
| Name |
National institute of siddha |
| Address |
Room no 26/27 ,
Department of nanju maruthuvam,
National Institute of Siddha,
Tambaram sanitorium
Chennai-600047,
Tamil nadu,
India. |
| 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 Yazhini S |
Ayothidass pandithar hospital |
Room no 26/27
National institute of siddha
Tambaram sanitorium
Chennai-600047
Tamilnadu
India
Chennai
TAMIL NADU |
7550001790
04422381314
yazhuyazhini1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National institute of siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L309||Dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gowri chindamani chendooram (internal) and Karappan thylam (external) |
Internal medicine 200 mg bd with thirikadugu chooranam and honey and external medicine twice a day for 40 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants having signs and symptoms of Karappan. Participants having duration of illness lesser than one month (acute Eczema). Participants having EASI SCORE lesser than 51. Participants willing to give blood samples for the investigations required |
|
| ExclusionCriteria |
| Details |
Pregnant and Lactating. Participants having secondary infection, bleeding disorder, diabetes mellitus, heart disease, tuberculosis,leprosy,scabies and psoriasis. Participants having fasting blood glucose level greater than 200 mg/dl and post prandial blood glucose level greater than 300mg/dl.Known hypertensive participants with blood pressure level greater than 140/90mm Hg. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of 30% in clinical signs and symptoms of Karappan which is assessed by using Eczema Area And Severity Index (EASI)Score after treatment |
3 months - patient screening. 7 months - patient enrollment. 2 month - outcome assessment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The following data will be documented before and after treatment, Changes in complete haemogram, Total RBC, total WBC, DC, ESR) and Changes in liver function test (serum total bilirubin, direct bilirubin, indirect bilirubin, SGOT, SPOT, alkaline phosphatase and gamma GT) |
3 months - patient screening . 7 months - patient enrollment. 2 months - outcome assessment |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="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
|
Eczema is broadly applied to a range of persistent or recurring skin rashes characterized by redness, skin edema, itching and dryness, with possible crusting, flaking, blistering, cracking, oozing or bleeding • The lifetime prevalence of eczema is about 15-30% in children and 2-10% in adultsPRIMARY OBJECTIVE: To evaluate the therapeutic effectiveness of siddha formulation Gowrichindamani chenduram (Internal) and Karappan thylam (External medicine) in the management of Karappan (Eczema) by assessment of reduction in EASI Score among out-patients attending Ayothidass Pandithar Hospital, National Institute of Siddha SECONDARY OBJECTIVE : To document the following parameters before and after treatment •Changes in Complete Haemogram (Hb,total RBC,Total WBC, DC, Erythrocyte Sedimentation Rate) •Changes in Liver function Test (Serum total bilirubin, Direct bilirubin, Indirect bilirubin, SGOT, SGPT, Alkaline phosphatine, Gamma GT) •Changes in Kidney Function Test( Blood urea,Serum creatinine ) •Changes in Lipid profile (Total cholesterol, TGL,HDL,LDL,VLDL) •Changes in Absolute eosinophil count, IgE and siddha assessments STUDY DESIGN: An open clinical trial PRIMARY OUTCOME : Significant reduction of 30% in clinical symptom which is assessed by using Eczema Area and Severity Index after treatment. SECONDARY OUTCOME : The following parameters will be documented before and after treatment changes in Complete Haemogram , Liver function Test ,Kidney Function Test ,Absolute eosinophil count, IgE and siddha assessments. |