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

Fujian Academy of Traditional Chinese Medicine

Status and phase: Unknown; Early Phase 1

Conditions: Postmenopausal Osteoporoses

Treatments: Drug: Calcitriol capsules; Drug: Xulin Jiangu granules

Study type: Interventional

Funder types: Other

Identifiers

NCT03563235

2018R1035-4

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Xulin Jiangu granules

Experimental group

Description:

Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months

Treatment:

Drug: Xulin Jiangu granules

Drug: Calcitriol capsules

Calcitriol capsules

Active Comparator group

Description:

Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months

Treatment:

Drug: Xulin Jiangu granules

Drug: Calcitriol capsules