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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 Trial 
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) 
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)  
Name  Address 
nil   
 
Countries of Recruitment
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  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  
Status 
Not Applicable 
 
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
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Not Applicable 
Method of Concealment
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Not Applicable 
Blinding/Masking
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Not Applicable 
Primary Outcome
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Outcome  TimePoints 
Universal Pain Assessment Scale (0-10)  before and after treatment 
 
Secondary Outcome
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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" 
Phase of Trial
Modification(s)  
Phase 2 
Date of First Enrollment (India)
Modification(s)  
01/01/2011 
Date of First Enrollment (Global)  01/01/2011 
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).  
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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