Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Tablet naltrexone 5 mg: To be administered once daily for 8 weeks
Control Intervention1: Mached placebo: To be administered once daily for 8 weeks
Sponsors
AIIMS Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: - Patients of either sex having age between 45 75 years with clinical diagnosis of knee osteoarthritis grade 1 or 2 according to Kellgren and Lawrence system for classification of osteoarthritis - Patient with VAS score more than 2 out of 10 - Patients who are willing to give informed written consent
Exclusion criteria
Exclusion criteria: - Patient with history of hypersensitivity to naltrexone - Patient on treatment with any type of prior opioid medication - Patient with history of opioid or alcohol abuse - Patient on treatment with systemic corticosteroid within the last 4 weeks - Patient with diagnosis other than osteoarthritis - Patient on treatment with intra-articular injection such as corticosteroids or hyaluronic acid - Patient with abnormal liver functions with total bilirubin more than 2.5 mg per deciliter - Patient with severe acute infection, uncontrolled diabetes mellitus congenital or acquired immunodeficiency liver cirrhosis severe cardiac disease or myocardial infarction in last 1 month - Patients with blood hemoglobin levels less than 9 grams per dL, absolute lymphocyte count less than 500 cells and or absolute neutrophil count less than 1000 cells per cubic mm of blood - Patient with abnormal renal or liver functions with creatinine more than 2 mg per deciliter or serum total cholesterol more than 200mg per dl). - Patient with severe active infection like active tuberculosis hepatitis B or C or positive HIV serology at screening - Patient with known or suspected history of immunosuppression or history of opportunistic infections like tuberculosis histoplasmosis listeriosis coccidioidomycosis or aspergillosis - Pregnant or lactating woman or woman of childbearing age without effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of add on low dose naltrexone against add on placebo in patients with knee osteoarthritis using reduction in the VAS score for 8 weeks.Timepoint: At baseline 4 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients achieving WOMAC score 0 or a reduction of 10 grade from baseline To compare the percentage of patients with Oxford Knee Score (OKS) pain subscale of 28 or a 3-point reduction from baseline To evaluate and compare the EQ-5D score from base line To evaluate and compare changes in serum TNF alpha level from baseline To assess change in complete blood count, ESR, liver function test, renal function test, and serum lipid profile from baseline to 4 and 8 weeks after therapy. To evaluate the number and frequency of rescue medications needed in LDN group compared to placebo group. To evaluate the safety and tolerability of Low Dose Naltrexone compared to placebo in patients with knee osteoarthritis, as measured by the incidence and severity of adverse events. Timepoint: At baseline 4 and 8 weeks | — |
Countries
India
Contacts
Public ContactDR RINI FASNI K
AIIMS Bhubaneswar 751019
Outcome results
None listed