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

NCT03563235 | Unknown Early Phase 1 DMC

• 1 other identifier: 2018R1035-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Postmenopausal Osteoporoses

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone density（BMD）

  BMD is the gold standard of oeteoporosis

  Xulin Jiangu treats for up to six months

Study Arms (2)

Xulin Jiangu granules

EXPERIMENTAL

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

Drug: Xulin Jiangu granules; Drug: Calcitriol capsules

Calcitriol capsules

ACTIVE COMPARATOR

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

Drug: Xulin Jiangu granules; Drug: Calcitriol capsules

Interventions

Xulin Jiangu granules DRUG

Xulin Jiangu granules tablets

Calcitriol capsules; Xulin Jiangu granules

Calcitriol capsules DRUG

Calcitriol capsules tablets

Calcitriol capsules; Xulin Jiangu granules

Eligibility Criteria

• Age: 50 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Academy of Traditional Chinese Medicine: lead

Study Sites (1)

Fujian Academy of Trational Chiness Medicine

Fuzhou, Fujian, 350003, China

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 20, 2018
• Study Start: September 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)