| CTRI Number |
CTRI/2024/02/062943 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY ON NIMBATHI THYLAM IN THE MANAGEMENT OF PORUTHU VAATHAM In CHILDREN |
|
Scientific Title of Study
|
PRE CLINICAL AND CLINICAL EVALUATION OF THE EFFECT ON ORAL ADMINISTRATION AND EXTERNAL APPLICATION OF "NIMBATHI THYLAM" IN THE MANAGEMENT OF "PORUTHU VATHAM" (OLIGO ARTICULAR IDIOPATHIC ARTHRITIS) IN PAEDIATRIC AGE GROUP |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRHTHILAGAVATHI |
| Designation |
PG Scholar |
| Affiliation |
GOVEMENT SIDDHA MEDICAL COLLEGE,PALAYAMKOTTAI |
| Address |
PG First year Department of Kuzhanthai Maruthuvam,Goverment siddha medical college and Hospital,Palayamkottai tirunelveli.
tirunelveli
TAMILNADU
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8072655853 |
| Fax |
|
| Email |
drthilagasankaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRJSRIRAM |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College And Hospital |
| Address |
Department of Kuzhanthai Maruthuvam ,Government Siddha Medical College And Hospital , Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486811230 |
| Fax |
|
| Email |
sriramsiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRJSRIRAM |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College And Hospital |
| Address |
Department of Kuzhanthai Maruthuvam ,Government Siddha Medical College And Hospital , Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486811230 |
| Fax |
|
| Email |
sriramsiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,PALAYAMKOTTAI ,THIRUNELVELI |
|
|
Primary Sponsor
|
| Name |
Dr.H.THILAGAVATHI |
| Address |
FIRST YEAR PG SCHOLAR,DEPARTMENT OF KUZHANDHAI MARUTHUVAM,GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,PALAYAMKOTTAI,THIRUNELVELI |
| 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 H THILAGAVATHI |
GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,PALAYAMKOTTAI,THIRUNELVELI |
DEPARTMENT OF KUZHANDHAI MARUTHUVAM , GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL
Tirunelveli
TAMIL NADU |
8072655853
drthilagasankaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Goverment Siddha Medical Colloge,Palayamkottai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M089||Juvenile arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
NIMBATHI THYLAM (INTERNAL AND EXTERNAL ADMINISTRATION) |
Should be administrated orally once a day after food in take. dosage (according to the age) 5 to 10 ml.Duration 21 days and external application. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.joint swelling
2.joint pain
3.joint stiffness
4.restricted joint movements |
|
| ExclusionCriteria |
| Details |
uveitis
fever
pallor
anorexia
muscle atrophy
rheumatic fever
rheumatoid arthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asess the effectiveness of NIMBATHI THYLAM (INTERNAL)& (EXTERNAL)for the management of poruthu vaatham and provide a better improvement in the health care of children. |
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)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/03/2024 |
| Date of Study Completion (India) |
04/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 evaluaion of the effect on oral administration and extrnal application of "NIMBATHI THYLAM" in the management of "PORUTHU VAATHAM" (OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS) in paediatric age group
BACKGROUND Juvenile idiopathic artiritis is a chronic joint swelling pain with functional limitation for atleast 6 weeka of unknown cause that starts before age of 16 years of age. Oligoarthiritis is the mildest and most common ype of JIA occurs in 50-60% of young people .
|