Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules

Study Overview
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Brief Summary
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Osteoporosis is a common senile disease with a high incidence. The Chinese medicine differentiation treatment has small side effects and can be taken for a long time, which has certain advantages. This project adopts the experience of the person in charge of the project-Xulin Jiangu Granules and clinically collects patients with postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome).

Detailed Description
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Randomized control method was used to observe the clinical efficacy of the treatment of postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome) with jiujian jiangu granules, combined with the gene expression of bone metabolism markers BALP, PINP, TRACP and S-CTX, and RANK, RANKL and OPG Detection, compared with the control group of ossification trihydrate capsules, to explore the mechanism of the treatment of postmenopausal osteoporosis by the continued Xulin Jiangu granules, and lay the foundation for the development of new drugs.

Official Title
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Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules

Conditions
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Postmenopausal Osteoporoses

Intervention / Treatment
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* Drug: Xulin Jiangu granules
* Drug: Calcitriol capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 2 years prior and met the diagnostic criteria for osteoporosis according to the clinical practice guidelines of traditional medicine for primary osteoporosis met the CM diagnostic criteria according to Syndrome Differentiation in Modern Research of Traditional Chinese Medicine Exclusion Criteria: patients who did not meet the diagnostic criteria for osteoporosis or CM standards patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases patients with abnormal liver and/or Shen function test results patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xulin Jiangu granules<br>Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months | Drug: Xulin Jiangu granules<br>* Xulin Jiangu granules tablets<br>Drug: Calcitriol capsules<br>* Calcitriol capsules tablets<br>|
| Active Comparator: Calcitriol capsules<br>Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months | Drug: Xulin Jiangu granules<br>* Xulin Jiangu granules tablets<br>Drug: Calcitriol capsules<br>* Calcitriol capsules tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density（BMD） | BMD is the gold standard of oeteoporosis | Xulin Jiangu treats for up to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, kidney deficiency and blood stasis syndrome, Xuling Jiangu Granules