A pilot study on combination of siddha formulation(Seenthil chooranam and Serankottai Nei) in the treatment of Rheumatoid Arthritis

Phase 3

Completed

Conditions: Rheumatoid arthritis, unspecified,

Registration Number: CTRI/2017/03/008100

Lead Sponsor: National Institute of Siddha

Brief Summary: 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 â€œViraesanathal vatham thalumâ€ 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission of this disease will monitored by Disease activity score of 28	48 days
joints(DAS28).	48 days

Secondary Outcome Measures

Name	Time	Method
Other clinical signs and symptoms will be reduced	48 days

Trial Locations

Locations (1): National Institute of Siddha
🇮🇳
Chennai, TAMIL NADU, India
National Institute of Siddha
🇮🇳Chennai, TAMIL NADU, India
Dr J Kingsley
Principal investigator
9524095099
kingsleyj01@gmail.com