| CTRI Number |
CTRI/2010/091/006125 [Registered on: 21/01/2011] |
| Last Modified On: |
02/08/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Siddha |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Siddha treatment for Joint pain
|
Scientific Title of Study
Modification(s)
|
A pilot study to evaluate the therapeutic efficacy of Siddha herbo mineral formulations Chandamarutha Chenduram (Internal) and Poonaga thylam (External) in the treatment of "Uthiravatha suronitham" (Rheumatoid arthritis) |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIS/MD/32091205 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrRadhika Madhavan |
| Designation |
PG Scholor |
| Affiliation |
National Institute of Siddha |
| Address |
II year, Maruthuvam Department,,National Institute of Siddha, Chennai,
Plot no 7, Ambai road (Southside)
Veeramanikapuram,
Melapalayam post,
Tirunelveli 627005
Chennai
TAMIL NADU
600047
India |
| Phone |
044-22411611 |
| Fax |
044-22381314 |
| Email |
mradhibsms@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
ProfDrKManickavasakam |
| Designation |
Director i/c |
| Affiliation |
National Institute of Siddha |
| Address |
Director i/c
National Institute of Siddha, Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
044-22381314 |
| Fax |
044-22381314 |
| Email |
dr.kmvm@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrNalini Sofia |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Lecturer, Maruthuvam Dept.
National Institute of Siddha Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
044-22411611 |
| Fax |
044-22381314 |
| Email |
dr.nalinisofia@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| National Institute of Siddha, Chennai, Tamil Nadu, India |
|
Primary Sponsor
Modification(s)
|
| Name |
National Institute of Siddha Chennai Tamil Nadu India |
| Address |
National Institute of Siddha Tambaram Sanatorium Chennai 47 Tamilnadu India |
| Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRadhika Madhavan |
National Institute of Siddha |
Maruthuvam department (Branch I) National Institute of Siddha-600047
|
044-22233213
044-22381314
mradhibsms@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Uthira vatha suronitham (Rheumatoid arthritis), |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Chandamarutha Chenduram |
65 mg internal(twice a day) with palm jaggery for 7 days followed by a break of 5 days and repeated this prescription till the course of 48 days ends. Every first day of break (re dieting) starts with head bath with the paste of ajowan seeds and cow's milk |
| Comparator Agent |
nil |
nil |
| Intervention |
Poonaga Thylam |
External Medicine, 50 ml (twice a day) applied externally over the affected part.
Dietary restriction: Diet free of salt and tamarind should be followed throughout the 48 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 15-60 years,
Sex: Both male and female
Patients having the symptoms of arthritis of three or more joints, symmetrical joint involvement, swelling especially in inter phalangeal joints, morning stiffness of joints, low grade fever, serum rheumatoid factor both positive and negative, anorexia & mental stress
Patients who are willing to give radiological investigation and provide blood for lab investigation
Patient willing to sign informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can opt out of the trial of his/her own conscious discretion |
|
| ExclusionCriteria |
| Details |
Cardiac disease
Hypertension
Diabetes mellitus
Use of narcotic drugs
Pregnancy and lactation
History of trauma
Tuberculosis
Bronchial asthma
Any other serious illness |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Universal Pain Assessment Scale (0-10) |
before and after treatment |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Reduction in other clinical symptoms |
Before and after treatment |
| Restricted movement assessment scale |
before and after |
| Hb & ESR variation |
Before and after |
| RA factor & CRP Variation |
Before and After treatment |
|
Target Sample Size
Modification(s)
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
01/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/01/2011 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Journal name: International Journal of Pharmacy and Pharmaceutical Sciences.
Published year: 2012
Volume : 4 Suppl 2 pg no: 154-156
Title : The Influence Of The Siddha Formulation Chandamarutha Chenduram On Serum Rheumatoid Factor In Uthiravatha Suronitham (Rheumatoid Arthritis).
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a single arm clinical trial evaluating the efficacy of siddha medicine, one of the indian systems of medicine, as an effective intervention strategy for the disease Uthiravatha Suronitham.
Uthiravatha Suronitham
This is one of 80 types of Vatha diseases mentioned in Siddha literatures. Symptoms of the disease Uthiravatha Suronitham of Siddha pathology can be correlated to the disease Rheumatoid arthritis in modern.
Word about drug
The medicines Chandamarutha Chenduram (Internal drug) and Poonaga thylam (External drug), which are unique herbo mineral combinations are selected from authenticated Siddha text books. The drug Chandamarutha Chenduram is administered at a dose of 65 mg orally twice a day with palm jaggery after food and the drug Poonaga thylam administered externally over the affected part to 40 patients included as per inclusion criteria for a period of 48 days with no further administration thereafter.
Purpose of study
The primary outcome measure of the siddha medicine is reduction in pain which is the most difficult part of this disease which is to be assessed by Universal pain assessment scale before and after treatment. As there has been no evidence of clinical trial conducted with the above mentioned drugs till today the investigator proposed this trial.
RESULTS
- Clinical study revealed that out of 40 cases, 38 (95%) cases have shown reduction in pain.
- Regarding HAQ questionnaire ( For assessment of restriction of movements) the score was improved in 97.5% cases. There was also reduction in other clinical symptoms after the treatment.
- The toxicity studies conducted (Acute and Long term toxicity studies - As per WHO Guidelines) revealed that the trial drug was safe even at 23.4mg/animal (Ten times that of normal dose). There were no abnormalities found in the blood and histopathological investigation of animals. Hence it can be reasonably assumed that the drug is safe for humans.
- There was significant reduction in the elevated lab parameters (C-Reactive protein, Rheumatoid factor, ESR etc) after the treatment indicating the control of the disease.
- There were no adverse reaction complained during the trial.
- A multicentric trial with large number of patients would throw more light on the efficacy of this line of treatment and mainstreaming with public health care activities.
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