CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome (PMOP)
Primary Purpose
Postmenopausal Osteoporosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Liuwei Dihuang Pill
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Osteoporosis, kidney yin deficiency syndrome, liuwei dihuang pill
Eligibility Criteria
Inclusion Criteria:
Patients were included if they were female Han Chinese patients who had undergone natural menopause 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"
- provided informed consent, which was approved by the Fujian Academy of Traditional Chinese Medicine Clinical Research Ethics Committee
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 MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Shen (Kidney) yin deficiency
the control group
Arm Description
Shen (Kidney) yin deficiency
the control group,there is no intervention
Outcomes
Primary Outcome Measures
osteoporosis treatment within six months of study enrollment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02981732
Brief Title
CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome
Acronym
PMOP
Official Title
CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome Regulating the Bone Osteoimmunology Mechanism by the OPG/RANKL/RANK Signal System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
xuhuijuan
4. Oversight
5. Study Description
Brief Summary
For nearly 112 million patients with osteoporosis in China, it is of great significance for preventing and treating by clearly understanding the molecular mechanism of kidney deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism for kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding of the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system using the technology of adenovirus associated virus. ②explore impacts of over-expression and silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③ analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone metabolism by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone metabolism, so as to demonstrate if the hypothesis of this study that "the molecular osteoimmunological mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP) is possibly closely related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal system on bone metabolism" is right or not.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Osteoporosis, kidney yin deficiency syndrome, liuwei dihuang pill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shen (Kidney) yin deficiency
Arm Type
Experimental
Arm Description
Shen (Kidney) yin deficiency
Arm Title
the control group
Arm Type
No Intervention
Arm Description
the control group,there is no intervention
Intervention Type
Other
Intervention Name(s)
Liuwei Dihuang Pill
Primary Outcome Measure Information:
Title
osteoporosis treatment within six months of study enrollment
Time Frame
Liuwei Dihuang Pills therapy(up to six months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
46 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients were included if they were female Han Chinese patients who had undergone natural menopause 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"
provided informed consent, which was approved by the Fujian Academy of Traditional Chinese Medicine Clinical Research Ethics Committee
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao xin
Phone
0591-83570813
Email
yjyllbgs@163.com
Facility Information:
Facility Name
Fujian Academy of Trational Chiness Medicine
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao xin
Phone
0591-83570813
Email
yjyllbgs@163.com
12. IPD Sharing Statement
Learn more about this trial
CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome
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