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

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 30, 2021

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

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

Arms, Groups and Cohorts

  • Experimental: Xulin Jiangu granules
    • Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months
  • Active Comparator: Calcitriol capsules
    • Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fujian Academy of Traditional Chinese Medicine
  • Provider of Information About this Clinical Study
    • Sponsor

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