| CTRI Number |
CTRI/2025/06/088612 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
A study on siddha diagnostic methodology including maruthuva jothidaviyal for Vibathiga kuttam |
|
Scientific Title of Study
|
An observational study on siddha diagnostic methodologies including maruthuva jothidaviyal for Vibathiga kuttam Palmoplantar psoriasis and its line of treatment |
| 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 M Santhiya |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical College and hospital |
| Address |
Department of Noinadal
Government siddha medical College and hospital Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8870282956 |
| Fax |
|
| Email |
sandymsss27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Balamurugan MD S |
| Designation |
Lecturer grade II |
| Affiliation |
Government siddha medical College and hospital |
| Address |
Government siddha medical College and hospital Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7010851494 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Balamurugan MD S |
| Designation |
Lecturer grade II |
| Affiliation |
Government siddha medical College and hospital |
| Address |
Government siddha medical College and hospital Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7010851494 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha medical college and hospital Palayamkottai Tirunelveli Tamilnadu 627002 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical College and hospital |
| Address |
Government siddha medical College and hospital Palayamkottai Tirunelveli Tamilnadu 627002 |
| 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 M Santhiya |
Government siddha medical College and hospital |
Room no 11
Department of Noinadal
Government siddha medical College and hospital Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU |
8870282956
sandymsss27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L449||Papulosquamous disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with the symptoms of
Fissures on palms of the hands
Cracked skin on the soles of the feet
Raised thickened skin on palms and feet
Silvery white scales
Dry skin
Pain
Itching
Erythema
Depression
Anxiety |
|
| ExclusionCriteria |
| Details |
Eczema
Contact dermatitis
Drug allergies
Patient who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the siddha diagnostic methods Neerkuri and neikkuri for Vibathiga kuttam |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess manikadai nool measurement for Vibathiga kuttam
To assess the medical astrology for Vibathiga kuttam |
2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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)
|
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
|
This study is to document the siddha diagnostic methods Neerkuri and Neikkuri and to assess the other diagnostic methods such as Manikadai nool and Maruthuva jothidaviyal for the patients of Vibathiga kuttam Palmoplantar psoriasis |