Siddha treatment for Joint pain

Phase 2

Completed

• Conditions: Uthira vatha suronitham (Rheumatoid arthritis)

• Registration Number: CTRI/2010/091/006125
• Lead Sponsor: National Institute of Siddha Chennai Tamil Nadu India

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

Cardiac disease Hypertension Diabetes mellitus Use of narcotic drugs Pregnancy and lactation History of trauma Tuberculosis Bronchial asthma Any other serious illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Universal Pain Assessment Scale (0-10)	before and after treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Institute of Siddha; 🇮🇳 Institute, India

National Institute of Siddha

🇮🇳Institute, India

DrRadhika Madhavan

Principal investigator

044-22233213

mradhibsms@gmail.com