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

Postmenopausal Osteoporoses Clinical Trial

— CSOPOPWXJG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03563235
• Other study ID #: 2018R1035-4
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2019
• Source: Fujian Academy of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blind Loop Syndrome
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporoses

Intervention

Drug:
• Xulin Jiangu granules
Xulin Jiangu granules tablets
• Calcitriol capsules
Calcitriol capsules tablets

Locations

Country	Name	City	State
China	Fujian Academy of Trational Chiness Medicine	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Academy of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density(BMD)	BMD is the gold standard of oeteoporosis	Xulin Jiangu treats for up to six months