Clinical study to compare the effect of Unani drug with aceclofenac in joints pai

Phase 2

• Conditions: Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

• Registration Number: CTRI/2019/05/019237
• Lead Sponsor: Central Research Institute of Unani Medicine Hyderabad

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients of any sex in the age group 35-55 years

Patients having Wajaâ??al-MafÄ?á¹£il (Rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV):

1)Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint

2)The absence of an alternative diagnosis for the observed synovitis (arthritis)

3) A total score of at least 6 from the individual scores in 4 domains:

a. Number and site of involved joints (range 0-5)

b. Serological abnormalities (range 0-3)

c. Elevated acute-phase reactants (range 0-1) d. Duration of symptoms (range 0-1)

Exclusion Criteria

Patients aged <35 years or >55 years

Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse)

Obese subjects (BMI >=30)

History or clinical evidence of Gastritis/ Peptic Ulcer Disease/ Renal Impairment

History or clinical evidence of any systemic inflammatory condition other than RA such as, juvenile chronic arthritis, spondyloarthropathy, IBD, psoriatic arthritis, active vasculitis, or gout that may interfere with evaluation

Are currently receiving or have received intra-articular treatment (e.g., corticosteroids or hyaluronic acid), oral or parenteral corticosteroids, or NSAIDs within 2 weeks of study entry and DMARDs or IFN therapy within 4 weeks prior to study entry or are anticipated to require IFN therapy during the study

History of hypersensitivity to study drug or any of its ingredients

Pregnant and lactating women

H/o Addiction (alcohol, drugs)

Significant Pulmonary/ Cardiovascular/Hepato-renal Dysfunction

Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies

Patient not willing to attend treatment schedule regularly

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) <br/ ><br>Disease Activity Score in 28 Joints (DAS28) <br/ ><br>Swollen Joints Count (SJC) <br/ ><br>Tender Joints Count (TJC)Timepoint: At baseline, 2wk, 4wk, & 6wk

Secondary Outcome Measures

Name	Time	Method
ab InvestigationsTimepoint: At Baseline and After Treatment