Study of knee osteoarthritis with evaluation of safety and efficacy of Bozidan in its management.

Phase 2

Not yet recruiting

• Conditions: Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,

• Registration Number: CTRI/2021/03/032178
• Lead Sponsor: Central council for research in Unani medicine New dehli

Brief Summary

Osteoarthritis is the most common form of arthritis and by far the most common joint disorder and a leading cause of disability world wide. The two cardinal features of osteoarthritis are joint space narrowing and osteophytes. Osteoarthritis is defined as painful degenerative process involving progressive detrioration of all joint surface and remodelling of subchondral bone that is not primarily inflammatory.Osteoarthritis is a disorder of diarthrodial (synovial joints) charecterised clinically by pain, tenderness, limitation of movements, crepitus, ocassionally effusion and variable degrees of local inflammation but without systemic effects, osteoarthritis is classified as primary (idiopathic) and secondary.Primary osteoarthritis is seen in weight bearing joints and is more common in obese patients older than 50 years.Progression of primary osteoarthritis is slow and prognosis is better. Secondary osteoarthritis is monoarticular in which the reaction of a joint to some condition has produced incongruity in its surfaces because of mechanical derrangements. Waja al mafasil (Osteoarthritis) is also known as ghatya or hadaar. Waja al mafasil is an arabic term which is a combination of two words ’Waja’ which stands for pain and ’mafasil’ which stands for joints , thus waja al mafasil literally means joint pain and is defined as the pain which occurs in joints not associated with a particularpart but the pain which occurs in knee, it is known as osteoarthritis knee.. Waja al mafasil is characterised by pain, swelling and redness with crepitus. This disease is mostly present in those individuals who have abnormally high quantity of humours, which then reach to joints. This disease usually occurs due to abnormally high levels of phlegm (balgham), which get mixed with yellow bile (safra) and then with blood (dam) and with the excess of these humours waja-al-mafasil is caused. Ibn sena considered waja-al-mafasil ,niqris(gout) and irq al nisa (sciatica) as a disease of same genus.The charecteristic feature of waja al mafasil is that neither it ripens nor puss is formed in it.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-03-18
• Study Start: 2021-03-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinically and radiologically diagnosed patients.
• Kellgren and Lawrence grade 1,2 knee osteoarthritis.
• Patients who agree to sign the informed consent.

Exclusion Criteria

• Kellgren and Lawrence grade 3, 4 knee osteoarthritis.
• pregnant and lactating women.
• BMI greater than 35kg per meter square.
• History of recent knee infection.
• Previous knee surgery.
• patients with rheumatoid arthritis.
• patients with history of systemic disease like diabetes, cardiovascular,hypertension,impaired renal or hepatic function.
• patients who refuse to give the written consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in signs and symptoms of primary knee osteoarthritis.	45 days

Secondary Outcome Measures

Name	Time	Method
heamatological and biochemical assessment for safety	45 days

Trial Locations

Locations (1)

Regional Research Institute of Unani Medicine, Srinagar; 🇮🇳 JAMMU, & KASHMIR, India

Regional Research Institute of Unani Medicine, Srinagar

🇮🇳JAMMU, & KASHMIR, India

Mir Idrees Hanief

Principal investigator

7006929405

dr.idreeshanief123@gmail.com