To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II).
Sample size 66 volunteers The patients were divided randomly into 2 treatment groups. The patients in group 1 received the SHT extract 300 mg/day (1 capsule of 100 mg SHT extract three times daily before meals). The patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). In addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of Gastrointestinal adverse effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
The concentration of SHT extract is 100 mg per capsule
Diclofenac sodium, 25 mg enteric-coated tablets
Mr. NARIN KAKATUM
Bangkok, BKK, Thailand
RECRUITINGPain score 1
Pain score from Visual analog scale
Time frame: 28 day
Pain score 2
Pain score from Modified WOMAC score (from Modified Thai WOMAC index)
Time frame: 28 day
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