The Efficacy and Safety of Habb-i Dard-i Mafasil in Wajaâ?? al-MafÄ?á¹£il (Osteoarthritis)

Phase 2

• Conditions: Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

• Registration Number: CTRI/2021/08/036008
• Lead Sponsor: ational research institute of Unani medicine for skin disorders

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

1. Participants of any gender aged between 40 and 65 years

2. Clinical and Radiographic Knee Osteoarthritis as per the following

American College of Rheumatology (ACR) criteria:

a. Knee Pain

b. Osteophytes on Knee Radiograph, and

c. At least 1 of the following 3 criteria:

i. Age >=40 years (revised as per Sl. No. 1)

ii. Morning Stiffness lasting <=30 minutes

iii. Crepitus on Active Knee Motion

3. Knee OA of Kellgren-Lawrence Grade 1 to 3

4. Body Mass Index (BMI): <40 kg/m2

5. Willing to come for regular follow-up visits for entire duration of the study

6. Ability to provide Written Informed Consen

Exclusion Criteria

1. Age <40 years and >65 years

2. Knee OA of Kellgren-Lawrence grade IV

3. BMI >=40

4. Patients with Knee Joint Effusion

5. Secondary OA, Inflammatory joint diseases (e.g., RA, ankylosing

spondylitis, psoriatic arthritis, gout), or any other type of arthritis

6. Patients on long-term steroid treatment

7. H/o having received intra-articular knee injection (corticosteroids or

hyaluronan), or any investigational drug in the previous one month

8. Any significant systemic diseases (cardiovascular, gastrointestinal,

hepatic, renal, neurologic or psychiatric disorder)

9. Known hypersensitivity to study drug or any of its ingredients

10.Pregnant and lactating women

11.H/o addiction (alcohol, drugs)

12.Unwilling to come for regular follow-up for entire duration of the study

13.Patients considered not eligible in the Investigatorâ??s opinion during the

study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified