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

Early Phase 1UnknownNCT03563235

Fujian Academy of Traditional Chinese Medicine60 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postmenopausal Osteoporoses

Interventions

Xulin Jiangu granulesDRUG

Xulin Jiangu granules tablets

Calcitriol capsulesDRUG

Calcitriol capsules tablets

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Fujian Academy of Trational Chiness Medicine

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

Bone density（BMD）

BMD is the gold standard of oeteoporosis

Time frame: Xulin Jiangu treats for up to six months

Data from ClinicalTrials.gov

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