CTRI/2019/04/018450RecruitingPhase 2
A randomized, controlled, open label, triple arm, prospective clinical study for therapeutic evaluation of Qurs-e-Mafasil Jadeed with and without Hijama biâ??l Shart (Wet cupping) in knee Osteoarthritis with special reference to selective Biomarkers
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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