The Study of Chinese Medicine for the Treatment of Primar... | NCT05370898

NCT05370898

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Traditional Chinese medicine	Experimental	On the basis of general symptomatic treatment of caltrate D，patients in experimental group use the traditional Chinese medicine application prescription.	Drug: Caltrate D Drug: Chinese medicine prescription
Comparator: placebo	Placebo Comparator	On the basis of general symptomatic treatment of caltrate D，patients in placebo group use the simulate granule of traditional Chinese medicine application prescription.	Drug: Caltrate D Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caltrate D	Drug	Caltrate D is allowed for basic treatment when the patient is diagnosed with primary osteoporosis (Kidney Yang Deficiency Syndrome).Take it continuously for 3 months.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of VAS pain score of low back	Draw a straight line with a length of 10 cm on the white paper and mark "painless" and "severe pain" on both ends respectively to form VAS. The patient makes a mark on the straight line according to the degree of pain he feels. The distance from the starting point to the mark is the quantified degree of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain.	Change from baseline VAS score at 2 weeks.
Change of VAS pain score of low back	Draw a straight line with a length of 10 cm on the white paper and mark "painless" and "severe pain" on both ends respectively to form VAS. The patient makes a mark on the straight line according to the degree of pain he feels. The distance from the starting point to the mark is the quantified degree of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain.	Change from baseline VAS score at 1 month.
Change of VAS pain score of low back	Draw a straight line with a length of 10 cm on the white paper and mark "painless" and "severe pain" on both ends respectively to form VAS. The patient makes a mark on the straight line according to the degree of pain he feels. The distance from the starting point to the mark is the quantified degree of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain.	Change from baseline VAS score at 3 months.
Change of Traditional Chinese medicine (TCM) syndrome score	According to the《expert consensus on the prevention and treatment of primary osteoporosis with reference to traditional Chinese medicine (2020)》, the quantitative evaluation table of TCM syndrome differentiation for osteoporosis with Kidney Yang Deficiency syndrome was formulated to evaluate the symptoms. Symptoms include primary and secondary symptoms, the primary symptoms were low back pain and soreness and weakness, the secondary symptoms include restricted movement of the lumbar spine，fear of cold and like to be warm，degree of frequency of urination. The primary symptom score was 0 (absent), 2 (mild), 4 (moderate), or 6 (marked)，the secondary symptom score was 0 (absent), 1 (mild), 2 (moderate), or 3 (marked).The obtained scores were summed to calculate the total score.

Secondary Outcomes

Measure	Description	Time Frame
Therapeutic mechanism	Serum level of EphrinB2, EphB4, Runx2 and VEGF in μg/mL，which is determined by enzyme linked immunosorbent assay（ELISA）.The higher the value, the better the bone condition. So as to verify the mechanism of Bugu Shengsui decoction.	Change from baseline at 3 months.

Other Outcomes

Measure	Description	Time Frame
Blood routine tests	Blood routine tests are performed with a blood routine analyzer to monitor the patient's health status.A normal blood routine indicates that the drug has no side effects. If abnormal conditions occur, take appropriate measures to treat them.	Up to 3 months.
Electrocardiogram

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;
It meets the syndrome differentiation standard of primary osteoporosis with Kidney Yang Deficiency Syndrome;
Female menopause > 2 years and 45 years ≤ age < 80 years, or 50 years ≤ male < 80 years;
Visual Analogue Score (VAS) was used to evaluate pain ≥ 4 points;
Voluntarily participate in this clinical study and sign the informed consent form.

Exclusion Criteria:

Osteoporotic fracture has occurred, or t-value > - 2.5;
Female premenopausal or menopausal years ≤ 2 years, female age < 45 years or ≥ 80 years, male age < 50 years or ≥ 80 years;
VAS pain score < 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;
Patients with malignant tumor, cardiovascular, cerebrovascular, liver disease, kidney disease, hematopoietic system and other serious primary diseases;
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.
Use drugs affecting bone metabolism, such as bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin and other drugs within 3 months before signing the informed consent;
History of serious mental illness or poor compliance;
Allergic constitution, allergy to known components of the drug, allergy to calcium or vitamin D;
Those who participated in other clinical trials within 3 months.

Rejection Criteria:

False diagnosis and false inclusion;
Not receiving one treatment;
During the study, in addition to the study medication, drugs known or likely to affect bone metabolism were used.

Shedding Standard:

The subjects withdrew from the test by themselves;
Loss of follow-up;
The subject received treatment at least once, and there were serious complications or complications and serious adverse events;
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.

Name	Role	Phone	Extension	Email
Xu Wei, Ph.D	Contact	13488716557		weixu.007@163.com
Ning Liu, Ph.D	Contact	15650071932		goat0707@163.com

Name	Affiliation	Role
Xu Wei, Ph.D	Wangjing Hospital of China Academy of Chinese Medical Sciences	Study Director
Ning Liu, Ph.D	Wangjing Hospital of China Academy of Chinese Medical Sciences	Principal Investigator