effect of herbal formulation on knee joint pain

Phase 2

Not yet recruiting

• Conditions: Bilateral primary osteoarthritis of knee,

• Registration Number: CTRI/2019/05/018972
• Lead Sponsor: Sayyed Abuzar Gaffari

Brief Summary

40eligible patients of Osteoarthritis Knee, after obtaining  written informed consent will be randomlyallocated either to test (n=20) or control group (n=20). Patients will beblinded for the study. In the test group; Polyherbal formulation 7 gram in the form of majoon will be give once aday for 21 daysorally. In the control drug 1Tablet Aceclofenac 100mgwill be given orally morningand evening for 21 days. The follow upof patients will be done at 7th, 14th and 21th . Assessment ofsubjective parameters will be done on each visit and objective parameterswillbe assessed before and after treatment.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-02-05
• Study Start: 2019-05-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with primary osteoarthritis, fulfilling the ACR clinical/radiological classification criteria.
• Patients of both genders between the age group of 35 to 65 years.

Exclusion Criteria

• Patients suffering with other forma of arthritis like, rheumatoid arthritis, rheumatic arthritis, psoriatic arthritis, ankylosing spondylitis gouty arthritis, infective arthritis, and systemic lupus erythematous (SLE).
• •Patients suffering from systemic diseases, like diabetes, endocrinal disorders, malignancies etc.
• •Patients with BMI ≥30.
• Patients giving the History of recent accident or trauma.
• Patients with severe restricted mobility.
• Pregnant and lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reducing the pain from baseline to the end of treatment.	30 days

Secondary Outcome Measures

Name	Time	Method
reducing the WOMAC score and improving the quality of life and also to assess its effect on other subjective parameters from baseline to end of treatment.	21 days

Trial Locations

Locations (1)

Luqman Unani Medical College Hospital and Research Centre; 🇮🇳 Bijapur, KARNATAKA, India

Luqman Unani Medical College Hospital and Research Centre

🇮🇳Bijapur, KARNATAKA, India

Dr sayyed abuzar gaffari

Principal investigator

7978560952

drsayyedabuzar@gmail.com