| CTRI Number |
CTRI/2014/11/005180 [Registered on: 07/11/2014] Trial Registered Retrospectively |
| Last Modified On: |
17/10/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical research on siddha medicine Gendhaga Vallaathi in the treatment of Uthira Vaatha Suronitham(Rheumatoid Arthritis) |
|
Scientific Title of Study
|
Clinical study on Uthira Vaatha Suronitham(Rheumatoid Arthritis)and the drug of choice is Gendhaga Vallaathi (Internal) and Vaatha samhari Thylam(External) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A RAJALAKSHMI |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPT. OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU
India
TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU
600047
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9487236968 |
| Fax |
044-22381314 |
| Email |
rajibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR S MOHAN |
| Designation |
DEAN |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU
600047
India
TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU
600047
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
044-22411611 |
| Fax |
044-22381314 |
| Email |
drmohan139@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR H VETHA MERLIN KUMARI |
| Designation |
LECTURER |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU
India
TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU
600047
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
044-22381314 |
| Email |
dr.vetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYOTHIDOSS PANDITHAR HOSPITAL |
|
|
Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI |
| 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 |
| DrARajalakshmi |
Ayothidoss pandithar Hospital |
OPD NO:1 Dept. of Maruthuvam,
National Institute of Siddha
Chennai-47
Kancheepuram
TAMIL NADU |
9487236968
rajibsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
UTHIRA VAATHA SURONITHAM (Rheumatoid arthritis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gendhaga Vallaathi (Internal) and Vaatha samhari thylam(External) |
6 gms of Gendhaga Vallaathi administered orally twice a day for a period of 48 days.Vaatha samhari thylam(External)will be issued 50 ml to apply the affected joints. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Guidelines for classification :
a. 4 of 7 criteria are required to classify a patient as having RA
b. Patients with 2 or more clinical diagnosis are not excluded
3) Criteria : Morning stiffness: stiffness in and around the joints lasting 1 hr before maximal improvement.
2) Arthritis of 3 or more joint areas: Atleast 3 joints areas , have soft tissue swellings or joint effusions not just bony overgrowth.The 14 possible joints areas involved are right or left proximal interphalangeal joint,metacarpophalangealjoint,wrist,elbow,knee,ankle, metatarsophalangeal joint
3) Symmetrical arthritis
4) Arthritis of hand joints-these should be atleast 6 weeks
5) Rheumatoid factor positive
6) Rheumatoid nodules [21]
7) Anti – CCP positive
8) Patients who had the pain score of 0 to 6.
9) Patients willing for admission and stay in IPD or willing to attend OPD
10)Patient willing to undergo Radiological investigation and provide blood and urine for laboratory investigation.
11) Patient willing to sign the informed consent stating that he/she will consciously stick to the treatment during 48 days but can opt out of the trial of his/her own conscious discretion.
|
|
| ExclusionCriteria |
| Details |
•Diabetes Mellitus
•Hypertension
•Pregnancy and lactation
•Any other serious systemic illness
•Drug Addicts
•SLE
•H/O undergone DMARDs (past 3 month)
•Patients who had the pain score of 7 to 10
•Osteoarthritis
•Tubercular Arthritis
•Gouty Arthritis
•Psoriatic Arthritis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is mainly assessed by UNIVERSAL PAIN ASSESSMENT SCALE- Numeric Rating Scale before and after treatment.
UNIVERSAL PAIN ASSESMENT SCALE:
Grade 0 : No Pain
Grade 1 -3 : Mild pain
Grade 4-6 : Moderate pain
Grade 7-10: Severe pain
|
PRE STUDY SCREENING AND AFTER TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is assessed by the following parameters before and after treatment.
1.Reduction in clinical symptoms
2.Health Assessment Questionnarie [20]
3.Hb and ESR variations.
4.RA and CRP variations
|
PRE STUDY SCREENING AND AFTER TREATMENT |
|
|
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 |
|
Date of First Enrollment (India)
|
15/05/2014 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
It is a single, non-randomized, open-label trial to determine the efficacy and safety of GENDHAGA VALLAATHI (Prepared from herbo mineral constitutents) in patients with Uthira vaatha suronitham (Rheumatoid arthritis). In this trial 40 patients will be recruited and the trial drug will be administered 6 gms twice a day for a period of 48 days. During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.
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