Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II

Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)

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.

Inclusion Criteria:

• No pregnancy
• No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
• No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study

Exclusion Criteria:

• Uncontrolled Hypertension (BP>140/90 mm.Hg.) BMI > 30
• Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
• On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline