| Disease | A MULTI-CENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL. A TOTAL OF 96 SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE WERE ENROLLED AND RANDOMIZED TO EITHER PLACEBO (N = 38) OR INTERVENTION (N = 38). THE INTERVENTION GROUP RECEIVED A COMBINATION OF UNCARIA TOMENTOSA BARK EXTRACT (300 MG),
BOSWELLIA SERRATA RESIN EXTRACT (200 MG), LEPIDIUM MEYENII ROOT EXTRACT(1000 MG) AND L-LEUCINE (700 MG), GIVEN AS 3 CAPSULES ONCE A DAY. THE TREATMENT PERIOD WAS 8 WEEKS, ASSESSMENTS MADE AT DAYS 7, 14, 28 AND 56. PRIMARY OUTCOME WAS REDUCTION IN TOTAL WOMAC SCORE. VAS PAIN, TOLERABILITY, INVESTIGATOR ASSESSMENTS, USE OF RESCUE MEDICATION, AND SAFETY ASSESSMENTS OF VITAL SIGNS. WOMAC SCORES (PAIN, STIFFNESS, PHYSICAL PERFORMANCE) STEADILY DECLINED OVER THE COURSE OF THE 8 WEEK STUDY IN BOTH GROUPS, BUT THE MAGNITUDE WAS SIGNIFICANTLY GREATER FOR THE INTERVENTION (P < 0.05). |