12week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BST106 on Osteoarthritis

Inje University Seoul Paik Hospital0 个研究点目标入组 80 人开始时间: 待定最近更新: 2020年12月2日

试验速览

暂无简介。

•Adult male and female between 40 years and 75 years
•Patients diagnosed more than 30mm in VAS (Visual analogue scale)
•Patients diagnosed grade I, II with kellgren & Lawrence grading scale in X-ray
•Those who agree to the written consent of the applicant and who can cooperate with the necessary visits and related tests and surveys for the study process

•(1) Subjects diagnosed with arthritis by specific factors othre than degenerative arthritis
•(2) Joint spacing less than 2mm
•(3) Subjects who are judged to have severe arthritis with bony spur, irregular articular surface and osteocystoma etc
•(4) Subjects with clinically significant cardiovascilar, immune, infectious and neoplastic diseases
•(5) Patients undergoing gastritis and gastric ulcers
•(6) Subjects with resistant hypertension (Upper than 160/100mmHg, After 10 minutes rest)
•(7) Subjects with resistant diabetes (Fasting glucose levels upper than 180mg/dl)
•(8) TSH lower than 0.1µIU/ml or upper than 10 µIU/ml
•(9) AST(GOT) and ALT(GPT) is at least 3 timesthe normal range
•(10) Creatinine is at least twice the normal range
•(11) Pregnant or nursing women
•(12) Subjects who is on a diet Health Functional Foods and medicine to improve joint/cartilage health
•(13) Subjects who are treated with mental disorders such as depression and schizophrenia.
•(14) Oriental medicine treatment of acupuncture, moxibustion, cupping therapy, herbal medicine, etc. within 2 month prior to the study
•(15) Participation in anothrt clinical trial within 2 month prior to the study
•(16) Hypersensitivity or allergy to the test materials
•(17) Participation who are judged to be unable to comply with the requirements of the test

发起方

Inje University Seoul Paik Hospital