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

Primary Purpose

Postmenopausal Osteoporoses

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Xulin Jiangu granules
Calcitriol capsules
Sponsored by
Fujian Academy of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporoses focused on measuring Osteoporosis, kidney deficiency and blood stasis syndrome, Xuling Jiangu Granules

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Fujian Academy of Trational Chiness Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xulin Jiangu granules

Calcitriol capsules

Arm Description

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

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

Outcomes

Primary Outcome Measures

Bone density（BMD）
BMD is the gold standard of oeteoporosis

Secondary Outcome Measures

Full Information

First Posted
May 31, 2018
Last Updated
February 25, 2019
Sponsor
Fujian Academy of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03563235
Brief Title
Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules
Acronym
CSOPOPWXJG
Official Title
Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Academy of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporoses
Keywords
Osteoporosis, kidney deficiency and blood stasis syndrome, Xuling Jiangu Granules

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xulin Jiangu granules
Arm Type
Experimental
Arm Description
Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months
Arm Title
Calcitriol capsules
Arm Type
Active Comparator
Arm Description
Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months
Intervention Type
Drug
Intervention Name(s)
Xulin Jiangu granules
Intervention Description
Xulin Jiangu granules tablets
Intervention Type
Drug
Intervention Name(s)
Calcitriol capsules
Intervention Description
Calcitriol capsules tablets
Primary Outcome Measure Information:
Title
Bone density（BMD）
Description
BMD is the gold standard of oeteoporosis
Time Frame
Xulin Jiangu treats for up to six months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Fujian Academy of Trational Chiness Medicine
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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