Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Group A: Qurs-e-Mafasil-jadeed in the dose of 2 pills (500 mg each) daily orally with water after meals
Intervention2: Group B (Unani Drug and Hijama Bil-Shart): Qurs-e-Mafasil-jadeed
Sponsors
Central Council for Research in Unani Medicine
Eligibility
Inclusion criteria
Inclusion criteria: Patients of any sex aged 40-70 years Patients having Moderate to severe Knee pain (pain more than 40 mm and less than 90 mm) after 50 feet Walking on a flat surface Patients of Knee OA with chronicity of more or equal to 6 months Patients having K L Grading criteria of grades II or III Patients with normal laboratory values. Patients willing to comply with the regular treatment schedule as per protocol
Exclusion criteria
Exclusion criteria: Anemia (less than 10g percent of Hb) and bleeding disorders Pregnant and Lactating Mothers Another type of arthritis, eg Rheumatoid arthritis, Psoriatic arthritis, Gouty arthritis Patients taking Anticoagulants, corticosteroid or NSAIDs or any other concomitant therapy History of Surgery, Tidal lavage/Arthroscopy of the joint involved, of affected knee within the past 1 year. Intra-articular (IA) corticosteroid injection of affected knee within a 3 months interval prior to baseline screening Patients with the gastro-intestinal disease, peptic ulcer and having fecal blood loss History of Systemic illness such as Liver, Kidney, Cardiac disorders, DM, HTN, Osteomyelitis, Tuberculosis, Known cases of Immunocompromised states (HIV or AIDS, etc.)/ Malignancies Patients who were not willing to be randomized Ongoing use of prohibited medication including NSAID, another oral analgesic, muscle relaxant, or a low-dose antidepressant for any chronic pain management Concomitant skin disease at the application site History of alcohol or Drug abuse, excessive smoking, Diagnosed neurological or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tenderness on the joint area Effusion and Swelling over the affected joint Range of movements (Goniometry) Walking timeTimepoint: At baseline, 2wk, 4wk, 6wk and end of the 8wk | — |
Secondary
| Measure | Time frame |
|---|---|
| X-ray grading Biomarkers used Assessment of safetyTimepoint: At baseline and end of the 8wk | — |
Countries
India
Contacts
Public ContactTasleem Ahmad
Central Research Institute of Unani Medicine
Outcome results
None listed