The Efficacy and Safety of Habb-i Dard-i Mafasil in Waja‘ al-MafÄá¹£il (Osteoarthritis)
- Conditions
- Diseases of the musculoskeletal system and connective tissue,
- Registration Number
- CTRI/2021/08/036008
- Lead Sponsor
- National research institute of Unani medicine for skin disorders
- Brief Summary
Osteoarthritis (OA) is a chronic degenerative disorder of unknown cause characterized by gradual loss of hyaline articular cartilage.It is the second most common rheumatologic problem and the most common joint disease with a prevalence of 22-39% in India. OA is more common in women than men. It has been reported in many studies that women have more multiple joint involvement than men as well as higher prevalence and severity of osteoarthritis of hands, knees, ankles and feet. In India, women especially menopausal women with age of 46 years are at early risk of osteoarthritis. Knee is the most common joint affected by osteoarthritis.In the classical Unani literature, the illness of joints pain mentioned under the caption of “Waja‘ al-MafÄá¹£ilâ€, which includes, other types of arthritis also. The term Waja‘ means pain and “Mafᾱṣil†means joints, hence “Waja‘ al-MafÄá¹£il†means pain in joints. Waja‘ al-MafÄá¹£il is also known as Gathiya (ArzÄnÄ«, 1931; 3 MajÅ«sÄ«, 2010) and this is one of the hereditary diseases (Ibn SÄ«nÄ, 2007). NSAIDs (Non-steroidal Anti-Inflammatory Drugs) are widely used in the symptomatic management of OA and other Rheumatic diseases. NSAIDs have property of blocking production of Prostaglandins (PGs). This is accomplished by inhibiting the activity of the enzyme PGG/H synthase, also called cyclooxygenase (COX). COX occurs in two isoforms, COX-1 and COX-2, which have different biological functions. Inhibition of COX-2 by NSAIDS blocks PG production at sites of inflammation or other forms of tissue damage, while inhibition of COX-1 in certain other tissues- most importantly platelets and the gastroduodenal mucosa can lead to common adverse effects of NSAIDS such as bleeding and gastrointestinal ulceration.(13) Hence, we cannot use the NSAIDs for long period because they have so many adverse effects. So, there is a need to search for alternate drugs that have less adverse effects. There are so many single as well as compound Unani formulations mentioned in classical Unani texts, which have been used in the treatment of Waja‘al-MafÄá¹£il by Unani Physicians since ages, but they need to be evaluated on scientific parameters in order to generate data regarding their safety and efficacy. Therefore, it has been planned to conduct the present clinical study titled “A Prospective, Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of Habb-i Dard-i Mafasil in Waja‘ alMafÄá¹£il (Osteoarthritis)â€
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- 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.
- Age <40 years and >65 years 2.
- Knee OA of Kellgren-Lawrence grade IV 3.
- 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 Investigator’s opinion during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The response to At baseline,2nd,4th,6th wk treatment will be assessed using the following parameters: At baseline,2nd,4th,6th wk 1. Western Ontario and McMaster Universities (WOMAC) Osteoarthritis At baseline,2nd,4th,6th wk Index At baseline,2nd,4th,6th wk 2. Visual Analogue Scale (VAS) At baseline,2nd,4th,6th wk 3. Joint Tenderness on a 4-Point Likert Scale (0-3) At baseline,2nd,4th,6th wk 4. Patient’s Global Assessment of Response to Therapy (PGA) on a 5- At baseline,2nd,4th,6th wk point Likert Scale (0-4) At baseline,2nd,4th,6th wk 5. Investigator’s Global Assessment of Response to Therapy (IGA) on At baseline,2nd,4th,6th wk a 5-point Likert Scale (0-4) At baseline,2nd,4th,6th wk 6. 50-Foot Walk Test (in Seconds) At baseline,2nd,4th,6th wk
- Secondary Outcome Measures
Name Time Method To compare the improvement in quality of life in patient with osteoarthritis. Baseline ,2nd,4th,6th wk
Trial Locations
- Locations (1)
National Research Institute Of Unani Medicine For Skin Disorders,AG colony Road,erragadda hyderabad
🇮🇳Hyderabad, TELANGANA, India
National Research Institute Of Unani Medicine For Skin Disorders,AG colony Road,erragadda hyderabad🇮🇳Hyderabad, TELANGANA, Indiakainat mahmoodPrincipal investigator7003361038mh8009222@gmail.com