Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Clinical and Radiographic Knee Osteoarthritis as per the following American College of Rheumatology (ACR) criteria Knee Pain Osteophytes on Knee Radiograph, and At least 1 of the following 3 criteria: Age more than 50 years Morning Stiffness lasting less than 30 minutes Crepitus on Active Knee Motion Radiographic Knee OA according to the Kellgren-Lawrence Grading System from Grade 1 to Grade 3. Body Mass Index (BMI) less than 40
Exclusion criteria
Exclusion criteria: Knee OA of Kellgren-Lawrence grade IV BMI more than 40 Patients with Knee Joint Effusion Secondary OA, Inflammatory joint diseases or any other type of arthritis Patients on long-term steroid treatment History of having received intra-articular knee injection (corticosteroids or hyaluronan) or any investigational drug in the previous month Any significant systemic diseases History of Bleeding Disorders Subjects with known allergy Pregnant and Lactating Women Participants not willing to sign the ICF and to attend cupping therapy schedule regularly Patients considered not eligible in the Investigator opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarker analysis is anticipated to show significant modulation in cartilage-related markers, such as PIIANP and CS846 reflecting therapeutic effects on cartilage synthesis and degradation. Cytokine profiling may also indicate shifts in inflammation, highlighting Hijama s potential impact on OA s inflammatory pathways. Additionally, shifts in metabolites and proteomics markers are expected to associated with OA progression and treatment responseTimepoint: Cupping will be done once a week for 4 weeks, and the primary outcome will be assessed on zero day from venous and cupping blood, then after 2 weeks from cupping blood only and after 4 weeks from cupping and venous blood. The duration of the study will be six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Wet Cupping Therapy in Knee Osteoarthritis assessed by the changes in WOMAC score, VAS scale, Likert Scale, 50-Foot Walk Test. Safety assessment of cupping therapyTimepoint: Efficay will be assessed at baseline, 1 week, 2 weeks, 3 weeks, 4 weeks Safety parameters will be done at baseline, 4 weeks | — |
Countries
India
Contacts
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad