Status:
WITHDRAWN
The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis
Lead Sponsor:
Sadat City University
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
30-60 years
Phase:
PHASE1
PHASE2
Brief Summary
metformin alleviates drug-induced osteoarthritis (OA)-like change in mice knee joint through activating autophagy and downregulating apoptosis. Metformin exerts its protective effects against OA throu...
Eligibility Criteria
Inclusion
- Primary osteoarthritis Patients recruited were between 30 to 60 years of age, with X-ray confirmed Kellgren-Lawrence grade13 II or III severity primary tibiofemoral OA, according to the American College of Rheumatology criteria.
Exclusion
- Those patients were excluded from the present study who:
- were of age less than 30 years or more than 60 years
- presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
- were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee
- had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study
- were having a known hypersensitivity to the used medications
- have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin\< 10.0 g/ dl or haematocrit \< 30%).
- Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04767841
Start Date
February 16 2021
End Date
December 31 2024
Last Update
July 14 2025
Active Locations (1)
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1
Faculty of Pharmacy
Shibīn al Kawm, Menoufia, Egypt, 13829