Status:
COMPLETED
Safety and Efficacy of Sahasthara ME vs Diclofenac ME for Treating Primary Knee Osteoarthritis
Lead Sponsor:
Thammasat University
Conditions:
Primary Knee Osteoarthritis
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
Brief Summary
Background: Sahasthara is a traditional Thai herbal remedy used for the anti-inflammatory treatment of the musculoskeletal system, while diclofenac sodium is one of the most topically administered ant...
Detailed Description
Outpatient participants, aged between 40 - 70 years old, were recruited. They were screened for symptoms of primary knee OA at the Department of Orthopedics, Thammasat University Hospital, Pathum Than...
Eligibility Criteria
Inclusion
- who had a pain score higher than 30 mm out of 100 mm on the visual analog scale (VAS)
- experiencing moderate to severe pain intensity from OA in one or both knees (patients who affected by knee OA bilaterally were evaluated, which more severely affected knee was included in the study) and had OA grade 1 to 3 (moderate/medium degree of pain) according to the Kellgren-Lawrence classification grading scale for OA severity
Exclusion
- had a history of hypersensitivity to ingredients in SHT ME or DF-ME
- were pregnant or breast feeding
- had previous surgery knee replacement or intra-articular steroid injections within 3 months of inclusion in the study
- were having any coexisting musculoskeletal diseases (including rheumatoid arthritis, septic arthritis, metabolic arthritis, gout, pseudogout, and traumatic arthritis ) or dermatologic disorder which affected the surrounding skin of the knees
- was assessed by body mass index (BMI) more than 32 kg/m2
Key Trial Info
Start Date :
October 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT06184685
Start Date
October 20 2021
End Date
December 8 2021
Last Update
December 28 2023
Active Locations (1)
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1
Thammasat University
Klong Luang, Changwat Pathum Thani, Thailand, 12120