clinical research on siddha medicine Gendhaga Vallaathi in the treatment of Uthira Vaatha Suronitham(Rheumatoid Arthritis)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/11/005180
• Date of registration: 07-11-2014
• Prospective Registration: No
• Primary sponsor: AYOTHIDOSS PANDITHAR HOSPITAL
• Public title: clinical research on siddha medicine Gendhaga Vallaathi in the treatment of Uthira Vaatha Suronitham(Rheumatoid Arthritis)
• Scientific title: Clinical study on Uthira Vaatha Suronitham(Rheumatoid Arthritis)and the drug of choice is Gendhaga Vallaathi (Internal) and Vaatha samhari Thylam(External)
• Date of first enrolment: 15-05-2014
• Target sample size: 40
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9227
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: DR H VETHA MERLIN KUMARI
• Affiliation: NATIONAL INSTITUTE OF SIDDHA

• Name: PROF DR S MOHAN
• Affiliation: NATIONAL INSTITUTE OF SIDDHA

Key inclusion & exclusion criteria

Inclusion criteria: 1) Guidelines for classification :

a. 4 of 7 criteria are required to classify a patient as having RA

b. Patients with 2 or more clinical diagnosis are not excluded

3) Criteria : Morning stiffness: stiffness in and around the joints lasting 1 hr before maximal improvement.

2) Arthritis of 3 or more joint areas: Atleast 3 joints areas , have soft tissue swellings or joint effusions not just bony overgrowth.The 14 possible joints areas involved are right or left proximal interphalangeal joint,metacarpophalangealjoint,wrist,elbow,knee,ankle, metatarsophalangeal joint

3) Symmetrical arthritis

4) Arthritis of hand joints-these should be atleast 6 weeks

5) Rheumatoid factor positive

6) Rheumatoid nodules [21]

7) Anti â?? CCP positive

8) Patients who had the pain score of 0 to 6.

9) Patients willing for admission and stay in IPD or willing to attend OPD

10)Patient willing to undergo Radiological investigation and provide blood and urine for laboratory investigation.

11) Patient willing to sign the informed consent stating that he/she will consciously stick to the treatment during 48 days but can opt out of the trial of his/her own conscious discretion.


Exclusion criteria: •Diabetes Mellitus

•Hypertension

•Pregnancy and lactation

•Any other serious systemic illness

•Drug Addicts

•SLE

•H/O undergone DMARDs (past 3 month)

•Patients who had the pain score of 7 to 10

•Osteoarthritis

•Tubercular Arthritis

•Gouty Arthritis

•Psoriatic Arthritis



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- UTHIRA VAATHA SURONITHAM (Rheumatoid arthritis)

Intervention(s)

Intervention1: Gendhaga Vallaathi (Internal) and Vaatha samhari thylam(External): 6 gms of Gendhaga Vallaathi administered orally twice a day for a period of 48 days.Vaatha samhari thylam(External)will be issued 50 ml to apply the affected joints.
Control Intervention1: nil: nil

Primary Outcome(s)

It is mainly assessed by UNIVERSAL PAIN ASSESSMENT SCALE- Numeric Rating Scale before and after treatment.



UNIVERSAL PAIN ASSESMENT SCALE:

Grade 0 : No Pain

Grade 1 -3 : Mild pain

Grade 4-6 : Moderate pain

Grade 7-10: Severe pain

Timepoint: PRE STUDY SCREENING AND AFTER TREATMENT

Secondary Outcome(s)

It is assessed by the following parameters before and after treatment.

1.Reduction in clinical symptoms

2.Health Assessment Questionnarie [20]

3.Hb and ESR variations.

4.RA and CRP variations

Timepoint: PRE STUDY SCREENING AND AFTER TREATMENT

Secondary ID(s)

NIL

Source(s) of Monetary Support

AYOTHIDOSS PANDITHAR HOSPITAL

Ethics review

Status: Approved
Approval date: 23/03/2013
Contact:

INSTITUTIONAL ETHICS COMMITTEE