The Study of Chinese Medicine for the Treatment of Primary Osteoporosis
NCT ID: NCT05370898
Last Updated: 2022-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-07-01
2023-05-01
Brief Summary
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Detailed Description
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Tele-medicine and information management system is established to help achieve follow-up interviews.Random numbers are generated by SAS 9.4 software. The subjects, caregivers, investigators and outcomes assessors in this study are all blinded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Traditional Chinese medicine
On the basis of general symptomatic treatment of caltrate D，patients in experimental group use the traditional Chinese medicine application prescription.
Caltrate D
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.
Chinese medicine prescription
The Chinese medicine application prescription is composed of Rhizoma Drynariae 12g, psoralen 10g, dog ridge 10g, medlar 10g, raw oyster 10g, ginseng 6g, Panax notoginseng 3g, Amomum villosum 6g.Patients take 200ml each time, twice a day. Treatment duration are 3 months.
Comparator: placebo
On the basis of general symptomatic treatment of caltrate D，patients in placebo group use the simulate granule of traditional Chinese medicine application prescription.
Caltrate D
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.
Placebo
The placebo is simulate granule of Chinese medicine application prescription. Patients take 200ml each time, twice a day. Treatment duration are 3 months.
Interventions
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Caltrate D
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.
Chinese medicine prescription
The Chinese medicine application prescription is composed of Rhizoma Drynariae 12g, psoralen 10g, dog ridge 10g, medlar 10g, raw oyster 10g, ginseng 6g, Panax notoginseng 3g, Amomum villosum 6g.Patients take 200ml each time, twice a day. Treatment duration are 3 months.
Placebo
The placebo is simulate granule of Chinese medicine application prescription. Patients take 200ml each time, twice a day. Treatment duration are 3 months.
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
80 Years
ALL
No
Sponsors
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Wangjing Hospital, China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Xu Wei, Ph.D
Role: STUDY_DIRECTOR
Wangjing Hospital of China Academy of Chinese Medical Sciences
Ning Liu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Wangjing Hospital of China Academy of Chinese Medical Sciences
Locations
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Wangjing Hospital of China Academy of Chinese Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Other Identifiers
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ZZ13-YQ-039
Identifier Type: -
Identifier Source: org_study_id
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