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

Early Phase 1

• Conditions: Postmenopausal Osteoporoses
• Interventions: Drug: Xulin Jiangu granules; Drug: Calcitriol capsules

• Registration Number: NCT03563235
• Lead Sponsor: Fujian Academy of Traditional Chinese Medicine

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26
• Study Start: 2019-09-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xulin Jiangu granules	Calcitriol capsules	Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months
Xulin Jiangu granules	Xulin Jiangu granules	Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months
Calcitriol capsules	Xulin Jiangu granules	Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months
Calcitriol capsules	Calcitriol capsules	Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months

Primary Outcome Measures

Name	Time	Method
Bone density（BMD）	Xulin Jiangu treats for up to six months	BMD is the gold standard of oeteoporosis

Trial Locations

Locations (1)

Fujian Academy of Trational Chiness Medicine; 🇨🇳 Fuzhou, Fujian, China