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

A Prospective, Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of Habb-i Dard-i Mafasil in Wajaâ?? al-MafÄ?á¹£il (Osteoarthritis)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/036008

Enrollment

Registered

2021-08-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Group A:Habb-i Dard-i Mafasil: Patients will be given Habb-i Dard-i Mafasil in the dose of 2 pills (500 mg each) twice daily orally with water after meals Control Intervention1: Group

Eligibility

Inclusion criteria

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 iii. Crepitus on Active Knee Motion 3. Knee OA of Kellgren-Lawrence Grade 1 to 3 4. Body Mass Index (BMI): 5. Willing to come for regular follow-up visits for entire duration of the study 6. Ability to provide Written Informed Consen

Exclusion criteria

Exclusion criteria: 1. Age 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.

Design outcomes

Primary

Measure	Time frame
The response to treatment will be assessed using the following parameters: 1. Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index 2. Visual Analogue Scale (VAS) 3. Joint Tenderness on a 4-Point Likert Scale (0-3) 4. Patientâ??s Global Assessment of Response to Therapy (PGA) on a 5- point Likert Scale (0-4) 5. Investigatorâ??s Global Assessment of Response to Therapy (IGA) on a 5-point Likert Scale (0-4) 6. 50-Foot Walk Test (in Seconds) Timepoint: At baseline,2nd,4th,6th wk	—

Measure

Time frame

The response to treatment will be assessed using the following parameters: 1. Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index 2. Visual Analogue Scale (VAS) 3. Joint Tenderness on a 4-Point Likert Scale (0-3) 4. Patientâ??s Global Assessment of Response to Therapy (PGA) on a 5- point Likert Scale (0-4) 5. Investigatorâ??s Global Assessment of Response to Therapy (IGA) on a 5-point Likert Scale (0-4) 6. 50-Foot Walk Test (in Seconds) Timepoint: At baseline,2nd,4th,6th wk

—

Secondary

Measure	Time frame
To compare the improvement in quality of life in patient with osteoarthritis.Timepoint: Baseline ,2nd,4th,6th wk	—

Countries

India

Contacts

Public ContactProf Qamar Uddin

National Research Institute Of Unani Medicine For Skin Disorders

ccrumhqrsnd58@gmail.com8700027178

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026