| CTRI Number |
CTRI/2017/05/008594 [Registered on: 19/05/2017] Trial Registered Prospectively |
| Last Modified On: |
18/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of siddha drug Vaatha choornam (internal) and Vaatha mega narayana ennai (External) in the treatment of Rheumatoid arthritis(joint pain) (Valiazhal keelvayu) |
|
Scientific Title of Study
|
Preclinical and clinical study of siddha drugs Vaatha chooranam (internal) and Vaatha mega narayana ennai (external) in the treatment of Vali Azhal keel vayu(Rheumatoid Arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR TR Nishitha |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
Department of sirappu maruthuvam, National institute of siddha Tambaram sanatorium
Department of sirappu maruthuvam, National institute of siddha Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9489472524 |
| Fax |
|
| Email |
dr.trnishitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NJ Muthukumar |
| Designation |
Head of the department i/c |
| Affiliation |
National Institute of Siddha |
| Address |
OPD NO 3, Department of sirappu maruthuvam, National institute of siddha, Tambaram sanatorium, Chennai-47.
OPD NO 3, Department of sirappu maruthuvam, National institute of siddha Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962006843 |
| Fax |
044-22381314 |
| Email |
njmuthu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NJ Muthukumar |
| Designation |
Head of the department i/c |
| Affiliation |
National Institute of Siddha. |
| Address |
OPD NO 3, Department of sirappu maruthuvam, National institute of siddha, Tambaram sanatorium, Chennai-47.
OPD NO 3, Department of sirappu maruthuvam, National institute of siddha, Tambaram sanatorium, Chennai-47.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962006843 |
| Fax |
044-22381314 |
| Email |
njmuthu@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidos pandithar hospital, National Institute of Siddha,Tambaram Sanatorium, Chennai-47. |
|
|
Primary Sponsor
|
| Name |
Ayothidoss pandithar hospital |
| Address |
National institute of siddha Tambaram sanatorium, Chennai-47 |
| 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 TR Nishitha |
Ayothidoss pandithar hospital |
OPD NO 3 Department of sirappu maruthuvam, National institute of siddha Tambaram sanatorium
Kancheepuram
TAMIL NADU |
9489472524
dr.trnishitha@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 |
Vali Azhal Keel Vayu (Rheumatoid arthritis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muddakku vatha choornam (internal) and vatha mega Narayana ennai(external) |
2 gm of Muddakku vatha choornam administered orally twice a day with honey for a period of 48 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 20- 60 years
2) Sex: Both male and female
3) Any of the following three symptoms
Pain and swelling in three or more joint
Morning Stiffness
Rheumatoid factor positive
Deformities like Swan neck and Buttton hole deformity
Rheumatoid nodules
4) Symmetrical joints involvement
5) patient willing to undergo laboratory Investigation
6) Patient willing to sign the informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Pregnancy and lactation
2) Tubercular arthritis
3) Gouty arthritis
4) Diabetic Mellitus
5) Malignant Hypertension
6) Any other systemic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rheumatoid arthritis is diagnosed by European League against rheumatism (EULAR)and prognosis is assessed by modified health assessment questionnaire (MHAQ)
Reduction of pain is assessed before and after treatment by Universal pain assessment scale using Questionnaire
Improvement in restriction of movements is assessed by restricted movements assessment scale |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Safety study of drugs Muddakku vatha choornam
2)Analytical study of drug muddakku vatha choornam |
48 days |
|
|
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)
|
25/05/2017 |
| 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) |
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 efficacy of Muddakku vatha choornam (prepared from herbal constituents) in patients with Vali azhal keel vayu (Rheumatoid arthritis). In this trial 40 patients will be recruited and the trial drug will be administered 2 gm twice a day with honey for a period of 48 days. During the trial period if any AE/SAE/SUSAR will be noticed and reffered to pharmacovigilance department 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 safety 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 India Journal of Medical Research. |