| CTRI Number |
CTRI/2023/09/057492 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study to evaluate the effectiveness of Linga chendooram in the management of Uthiravatha suronitham (Rheumatoid arthritis) |
|
Scientific Title of Study
|
A pilot clinical trial to evaluate the effectiveness of Linga chendooram in the management of Uthiravatha suronitham (Rheumatoid arthritis) |
| 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 Janani Syamaroopa Jnanathapaswini |
| Designation |
Full time PhD scholar |
| Affiliation |
National Institute of Siddha,Tambaram,Chennai |
| Address |
Dr Janani Syamaroopa Jnanathapaswini
Full time PhD scholar
Department of Pothu Maruthuvam
National Institute of Siddha
Tambaram,Chennai 47
Chennai
TAMIL NADU
47
India |
| Phone |
9447709745 |
| Fax |
|
| Email |
jsrjtp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. T. Lakshmikantham MD(S) Ph.D. |
| Designation |
Associate Professor and Head of Department (i/c) Department of Maruthuvam |
| Affiliation |
National Institute of Siddha,Tambaram,Chennai |
| Address |
Dr. T. Lakshmikantham MD(S) Ph.D.
Associate Professor and Head of Department (i/c)
Department of Maruthuvam
National Institute of Siddha, Chennai-4
Chennai
TAMIL NADU
47
India |
| Phone |
9025575185 |
| Fax |
|
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janani Syamaroopa Jnanathapaswini |
| Designation |
Full time PhD scholar |
| Affiliation |
National Institute of Siddha,Tambaram,Chennai |
| Address |
Dr Janani Syamaroopa Jnanathapaswini
Full time PhD scholar
Department of Pothu Maruthuvam
National Institute of Siddha
Tambaram,Chennai 47
Chennai
TAMIL NADU
47
India |
| Phone |
9447709745 |
| Fax |
|
| Email |
jsrjtp@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium, Chennai 600047 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Janani Syamaroopa Jnanathapaswini |
National Institute of Siddha |
National Institute of Siddha
Tambaram,Chennai 47
Department of Maruthuvam(General Medicine)
Room No.8
Chennai
TAMIL NADU |
9447709745
jsrjtp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,National Institute of Siddha ,Tamaram,Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Linga Chendooram |
65 mg twice daily with honey
Oral route
duration : 45 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Onset of arthritis after the age of 16 years
Positive for rheumatoid factor (RF)
Anti - CCP
Either an erythrocyte sedimentation rate (ESR) of greater than 30 mm/hr OR
C-reactive protein level greater than 1.0 mg/dl (normal less than 0.4)
Diagnosis of Uthira Vatha Suronitham, as defined by fulfilling at least more than two articular involvements
Minor
Morning stiffness
Willing to take study medication
Willing to follow diet restriction
Patients giving informed consent (Signed or oral witnessed, according to local regulations) before any Protocol specific
procedures. |
|
| ExclusionCriteria |
| Details |
Uncontrolled Diabetes Mellitus
Uncontrolled Hypertension
Cardiac disease
Renal disease
Neurological disorders
Pregnancy and lactation
History of alcohol or substance abuse
Active infection, or chronic or persistent infection that might
worsen with immunosuppressive treatment
Patients who have already participated in a new drug study in
the past 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain and swelling of the joints |
Baseline and 12 th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the clinical laboratory parameters related to RA RA Factor CRP ESR etc |
Baseline ad 12th wek |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
15/09/2023 |
| 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 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
|
A clinical study to evaluate the effectiveness of Linga chendooram in management of Uthiravathasronitham ie Rheumatoid arthritis 10 patients will be conducted at National institute of Siddha Tamabaram sanatorium Chennai-47 from September to November. 2023 |