Osteoarthritis of the knee with deficiency of the liver and kidney
Conditions
Interventions
Experimental group:Mi Gu Capsule
Control group:Blood-nourishing and Hard-softening Capsule
Sponsors
Shuguang Hospital Affliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of osteoarthritis of the knee and the criteria of deficiency of the liver and kidney. A. Diagnostic criteria for osteoarthritis of the knee: (Orthopedics and Traumatology Branch of China Association for the Promotion of Chinese Medicine Research, 2020 edition; American Rheumatism Association, 1995 edition) a. Recurrent knee pain in the last 1 month; b. Age 45-80 years old; c. Morning stiffness =30 min; d. Bone friction sound (sensation) during activity; e. X-ray (standing or weight-bearing position) shows narrowing of the joint space, subchondral osteosclerosis and/or cystic degeneration, and formation of bone capillaries at the joint margin. The diagnosis can be made if any 2 of a and bcde are met. B. Criteria of deficiency of liver and kidney (refer to Guidelines for Clinical Research of New Chinese Medicines (for trial implementation), Criteria for Diagnosis and Efficacy of Traditional Chinese Medicine, and Guidelines for Diagnosis and Treatment of Common Diseases in Orthopedics and Traumatology of Traditional Chinese Medicine) a. Primary symptom: vague pain in the knee joint. b. Secondary symptoms: weak and aching pain in the waist and knee joints, worse in case of labor. c. Tongue and pulse: red tongue with little moss; sunken and weak pulse. (2) Postmenopausal women aged 45-80 years old with more than 1 year of natural menopause. (3) Voluntary subjects who are able to accept the experimental medication and ensure the completion of the treatment program.
Exclusion criteria
Exclusion criteria: (1) Those with previous diabetes mellitus, hyperthyroidism, malignant tumors, severe liver and kidney diseases and other important organs; (2) Those with combined serious primary diseases such as cardiovascular, hepatic, renal and hematopoietic systems; (3) Those who are allergic or hypersensitive to the study drug; (4) Those who do not cooperate with the treatment and do not follow the prescribed medication; (5) Serious adverse reactions to the drugs used in the study, or important organ diseases, organ dysfunction and other conditions that prevent them from cooperating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster University osteoarthritis index, WOMAC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chinese Medicine Score;Knee Pain Score(VAS); | — |
Countries
China
Contacts
Public ContactZheng Yuxin
Shuguang Hospital Affliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed