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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03563235
Acronym
CSOPOPWXJG
Enrollment
60
Registered
2018-06-20
Start date
2019-09-01
Completion date
2021-12-31
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporoses

Keywords

Osteoporosis, kidney deficiency and blood stasis syndrome, Xuling Jiangu Granules

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.

Interventions

DRUGXulin Jiangu granules

Xulin Jiangu granules tablets

Calcitriol capsules tablets

Sponsors

Fujian Academy of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Bone density(BMD)Xulin Jiangu treats for up to six monthsBMD is the gold standard of oeteoporosis

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026