| CTRI Number |
CTRI/2017/03/008100 [Registered on: 15/03/2017] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A pilot study on combination of siddha formulation(Seenthil chooranam and Serankottai Nei) in the treatment of Rheumatoid Arthritis |
|
Scientific Title of Study
|
A pilot study on combination of siddha formulation 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 J kingsley |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Dept of Gunapadam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9524095099 |
| Fax |
|
| Email |
kingsleyj01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Visweswaran |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Dept of Gunapadam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9962542755 |
| Fax |
|
| Email |
svisu11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sivakumar |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
DEPARTMENT OF GUNAPADAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
TAMBARAM SANATORIUM
CHENNAI 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9962528338 |
| Fax |
|
| Email |
ssknis@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,Tambaram Sanatorium,Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
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 J Kingsley |
National Institute of Siddha |
Room No;2,
Department of Gunapadam
Tambaram sanatorium,Chennai-47
Chennai
TAMIL NADU |
9524095099
kingsleyj01@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
Perons affected with Rheumatoid Arthritis, (1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Seenthil chooranam |
2g twice daily with lukewarm water for 48 days |
| Intervention |
Serankottai Nei |
10 drops with milk twice daily for 48 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects suffering from arthritis of two or more joints
3.Morning stiffness.
4.Swelling especially in the inter-phalangeal joint.
5.Patients willing for admission and stay in IPD or willing to attend OPD
6.Patient willing to undergo Radiological investigation and for laboratory investigation.
7.Patient willing to sign the informed consent stating that he/she will consciously stick to the treatment during 48 days and the patients can opt out of the trial of his/her own conscious discretion. |
|
| ExclusionCriteria |
| Details |
1. Subjects with degenerative joint disease or other joint disease such as osteoarthritis,Gouty arthritis,psoriatic arthritis.
2.Subjects with severe disabiling arthritis and/ or bedridden.
3.Women who are pregnant,lactating.
4.Any other serious systemic illness such as diabetic,hypertensive,cardiac disorder,renal and hepatic disorder.
5.Those who unwilling to come for regular follow-up for the entire duration of he study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Remission of this disease will monitored by Disease activity score of 28
joints(DAS28). |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other clinical signs and symptoms will be reduced |
48 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2017 |
| Date of Study Completion (India) |
30/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2017 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
WORLD JOURNAL OF PHARMACEUTICAL RESEARCH VOLUME 7, ISSUE 18,1299-1307 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
According to Siddha system, Vali Azhal Keel vayu (Rheumatoid arthritis) is caused due to the derangement of Vali and Azhal humour. Treatment is mainly aimed at balancing these elevated humours (mukuttram) through Purgation and Medication. This is done because of the Siddhars saying “Viraesanathal vatham thalum†which means, by purgation vatham is normalised. Therefore 10ml of Merugulli thylam was given orally with hot milk as a purgative medicine on the first day of treatment. 2gm of Seenthil chooranam with lukewarm water and 10 drops of Serankottai nei with hot milk were given orally, twice daily for the next 45 days. The individual ingredients of Seenthil chooranam possess immunomodulatory, anti-inflammatory, analgesic, antipyretic, antioxidative, hepatoprotective and neuroprotective activities and Serankottai has antiinflammatory, antioxidative, antirheumatic, antiatherogenic, neuroprotective activities. which further proves the efficacy of these two drugs for Rheumatoid arthritis. Following are the important observations made from this study. 20 patients came with the symptoms of pain, swelling, tenderness and morning stiffness. 12 of these patients had restricted movements and 8 patients had fever. Das28 score was done before and after the treatment. After 48 days of treatment all the clinical signs and symptoms of patients were reduced . The data were analysed statistically and the result showed significant (p<0.05) improvement in the treatment of Vali Azhal Keel Vayu . The result of this study proves that the combination of Seenthil chooranam and Serankottai nei are effective in the treatment of Rheumatoid arthritis. |