| CTRI Number |
CTRI/2018/04/013541 [Registered on: 27/04/2018] Trial Registered Prospectively |
| Last Modified On: |
19/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of VAYU KEELAGA ILAKAM (Internal) with ERUKKATHY THYLAM (External)in the treatment of MUDAKKU VATHAM . |
|
Scientific Title of Study
|
Evaluation of safety and therapeutic efficacy of VAYU KEELAGA ILAKAM (Internal medicine) with ERUKKATHY THYLAM (External medicine) in the treatment of UTHIRA VATHA SURONITHAM(Rheumatoid arthritis). |
| Trial Acronym |
Uthira Vatha Suronitham (Rheumatoid arthritis) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMGohila |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Department of Maruthuvam
Tambaram Sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9786826681 |
| Fax |
04422381314 |
| Email |
gohilalakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKManickavasagam |
| Designation |
Head of the Department |
| Affiliation |
national Institute of Siddha |
| Address |
National Institute of Siddha
Department of Maruthuvam
Tambaram Sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444249798 |
| Fax |
04422381314 |
| Email |
dr.kmvm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHNalini Sofia |
| Designation |
lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
national Institute of Siddha
Department of Maruthuvam
Tambaram Sanatorium
kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
04422381314 |
| Email |
dr.h.nalinisofia@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
tambaram Sanatorium
Kancheepuram |
|
|
Primary Sponsor
|
| Name |
Ayothidoss Pandithar Hospital |
| Address |
National Institute of Siddha
tambaram Sanatorium
Kancheepuram |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMGohila |
Ayothidoss Pandithar Hospital |
National Institute of Siddha,
Department of Maruthuvam,
Room No: 1,
Tambaram,sanatorium
Kancheepuram
TAMIL NADU |
9786826681
0442238134
gohilalakshmi@gmail.com |
| DrMGohila |
Ayothidoss Pandithar Hospital |
National Institute of Siddha
Tambaram sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU |
9786826681
0442238134
gohilalakshmi@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 |
UTHIRA VATHA SURONITHAM (Rheumatoid arthritis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Vayu Keelaga Ilakam (Internal)
Erukkathy thylam (External) |
vayu keelaga ilakam ,Kottai pakkalavu (5gm) will be administrated orally,after food twice a day and Erukkathy thylam (Required quantity) will be applied all over the joints. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Insidious onset of polyarthritis with pain in the joints,Prolonged morning stiffness ( for 6 weeks or longer),Swelling of multiple involved joints (for 6 weeks or longer),Slow progressive signs of inflammation ,e.g.pain,Tenderness,warmth,eythymatous > 6 weeks,Symmetrical joints involvement,Swelling especially in inter phalangeal joints,RA factor positive or Negative,Patients willing to admission in IPD or willing to attend OPD,Patients willing to undergo Radiological investigations and other laboratory investigations,Patient willing to sign the informed consent stating that she/he will consciously stick to the treatment during 48 days but can opt out the trial his/her own conscious discretion. |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation,Tubercular arthritis,Any other serious systemic illness like Cancer,Cardiac Diseases,osteoarthritis,Psoriatic arthritis,Gouty arthritis,Diabetic Mellitus,Hypertension,Characteristic deformities of hands ans feet in Rheumatoid arthritis,Systemic complication of Rheumatoid arthritis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain will be Universal pain Assessment Scale.Other clinical signs and symptoms will be assessed by gradation method. |
After the 48 days of treatment , pain will be assessed by Universal pain Assessment Scale.Other clinical signs and symptoms will be assessed by gradation method. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome will be assessed by comparing the parameters ,before and after treatment (laboratory investigations such as RA factor,ESR,CRP,ASO titre ,Anti-CCP,X-ray affected joints AP and Lateral view),reduction of clinical symptoms. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/05/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a single non randomized open -label trial to determine the Safety and Therapeutic efficacy of VAYU KEELAGA ILAKAM (internal medicine ) with ERUKKATHY THYLAM (external medicine) in patients with UTHIRA VATHA SURONITHAM (Rheumatoid arthritis).In the trial 30 Rheumatoid arthritis patients will be recruited and the trial drug vayu keelaga ilakam ,kottai pakkalavu (5 gm)will be administrated orally after food twice a day and Erukkathy thylam( required quantity ) will be applied over the affected joints for a periods of 45 days.During the study period all the study related data will be recorded and documented in a separate trial master file for each and every patients.During the trial period if the patient develop any adverse effect he/she will be immediately referred to the chairman,pharmaco-Vigilance Committee ,NIS.If it will be mild event ,the patient will be treated in OPD-NIS.if the event will be reserve ,the patient will be referred to nearby Government Hospital and the investigator will be take over the patient,until he/she will get recovery.the treatment will be provided with free of cost.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 outcome of this trial will be published in Indian Journal of Medical Research. |