The Study of Chinese Medicine for the Treatment of Primary Osteoporosis
Sponsored by Wangjing Hospital, China Academy of Chinese Medical Sciences
About this trial
Last updated 4 years ago
Study ID
ZZ13-YQ-039
Status
Unknown
Type
Interventional
Phase
N/A
Placebo
Yes
Accepting
45 to 80 Years
All Sexes
Trial Timing
Ended 3 years ago
What is this trial about?
The purpose of this study is to evaluate the efficacy and possible mechanism of traditional Chinese medicine in the treatment of primary osteoporosis (Kidney Yang Deficiency Syndrome).It is a randomized, placebo-controlled trial.
What are the participation requirements?
Inclusion Criteria
1. It meets the diagnostic criteria of Western medicine for primary osteoporosis. the diagnostic criteria of osteoporosis based on the bone mineral density of central axis (lumbar spine 1-4, femoral neck or total hip) or 1/3 bone mineral density of distal radius measured by DXA is t-value ≤ - 2.5;
2. It meets the syndrome differentiation standard of primary osteoporosis with Kidney Yang Deficiency Syndrome;
3. Female menopause > 2 years and 45 years ≤ age < 80 years, or 50 years ≤ male < 80 years;
4. Visual Analogue Score (VAS) was used to evaluate pain ≥ 4 points;
5. Voluntarily participate in this clinical study and sign the informed consent form.
Exclusion Criteria
1. Osteoporotic fracture has occurred, or t-value > - 2.5;
2. Female premenopausal or menopausal years ≤ 2 years, female age < 45 years or ≥ 80 years, male age < 50 years or ≥ 80 years;
3. VAS pain score < 4;
4. Lumbar fusion or severe degenerative changes hinder the measurement of normal bone mineral density, and there are less than 2 consecutive intact lumbar vertebrae for DXA measurement and evaluation;
5. Patients with malignant tumor, cardiovascular, cerebrovascular, liver disease, kidney disease, hematopoietic system and other serious primary diseases;
6. secondary osteoporosis: diabetes, thyroid disease, Cushing syndrome and other metabolic diseases, rheumatoid arthritis, multiple myeloma, gout, absorption syndrome, systemic lupus erythematosus and other systemic diseases.
7. Use drugs affecting bone metabolism, such as bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin and other drugs within 3 months before signing the informed consent;
8. History of serious mental illness or poor compliance;
9. Allergic constitution, allergy to known components of the drug, allergy to calcium or vitamin D;
10. Those who participated in other clinical trials within 3 months.
Rejection Criteria:
1. False diagnosis and false inclusion;
2. Not receiving one treatment;
3. During the study, in addition to the study medication, drugs known or likely to affect bone metabolism were used.
Shedding Standard:
1. The subjects withdrew from the test by themselves;
2. Loss of follow-up;
3. The subject received treatment at least once, and there were serious complications or complications and serious adverse events;
4. Although the test was completed, the dosage of the subject was not within the range of 80%-120% of the dosage that should be taken.