Effect of polyherbal unani tablet (Qurs-e-Hudar) on selected blood parameters in rheumatoid arthritis patients

Not Applicable

Completed

• Conditions: Health Condition 1: M05-M14- Inflammatory polyarthropathies

• Registration Number: CTRI/2020/07/026278
• Lead Sponsor: Central council for research in unani medicine Ministry of AYUSH Govt of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-08-23
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

Patients having Wajaââ?¬Ë?al-MafÃ??sil (Rheumatoid arthritis) as defined by the following ACR-EULAR criteria:

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

2)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

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

2. Obese subjects (BMI �30)

3.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.

4.History or clinical evidence of any serious systemic illness, DM, TB, HIV infection etc

5. 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.

6.Screening laboratory test values, including S. Creatinine, BUN, S. Bilirubin outside the reference range, and SGOT, SGPT raised >2.5 times the ULN.

7.History of hypersensitivity to study drug or any of its ingredients.

8.Pregnant and lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and efficacy in terms of given biomarker levelsTimepoint: after 6 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
reduction in pain, VAS score and DAS28 score after 6 weeks of treatmentTimepoint: after 6 weeks of treatment