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

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ClinicalTrials.gov Identifier: NCT03563235
Recruitment Status : Not yet recruiting
First Posted : June 20, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Fujian Academy of Traditional Chinese Medicine

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).

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporoses Drug: Xulin Jiangu granules Drug: Calcitriol capsules Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Calcitriol

Arm Intervention/treatment
Experimental: Xulin Jiangu granules
Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months
Drug: Xulin Jiangu granules
Xulin Jiangu granules tablets

Drug: Calcitriol capsules
Calcitriol capsules tablets

Active Comparator: Calcitriol capsules
Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months
Drug: Xulin Jiangu granules
Xulin Jiangu granules tablets

Drug: Calcitriol capsules
Calcitriol capsules tablets




Primary Outcome Measures :
  1. Bone density(BMD) [ Time Frame: Xulin Jiangu treats for up to six months ]
    BMD is the gold standard of oeteoporosis



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563235


Locations
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China, Fujian
Fujian Academy of Trational Chiness Medicine
Fuzhou, Fujian, China, 350003
Sponsors and Collaborators
Fujian Academy of Traditional Chinese Medicine

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Responsible Party: Fujian Academy of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03563235     History of Changes
Other Study ID Numbers: 2018R1035-4
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fujian Academy of Traditional Chinese Medicine:
Osteoporosis
kidney deficiency and blood stasis syndrome
Xuling Jiangu Granules

Additional relevant MeSH terms:
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Calcitriol
Osteoporosis
Osteoporosis, Postmenopausal
Blind Loop Syndrome
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents