CClinicalTrials.gg
Status unknownNCT02981732PMOPUpdated Mar 27, 2017

CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome

An interventional study of Liuwei Dihuang Pill in Postmenopausal Osteoporosis, sponsored by xuhuijuan. Status unknown at 1 site in China. Open to female participants aged 46 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by xuhuijuan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
46 Years to 75 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Postmenopausal Osteoporosis

Keywords

  • Osteoporosis
  • kidney yin deficiency syndrome
  • liuwei dihuang pill
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In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 60 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

This is the only study on the registry with xuhuijuan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
46 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Shen (Kidney) yin deficiency

    Shen (Kidney) yin deficiency

    Other: Liuwei Dihuang Pill

  • No intervention
    the control group

    the control group,there is no intervention

Interventions

  • OtherLiuwei Dihuang Pill
06

What researchers measure

Primary outcomes

  1. osteoporosis treatment within six months of study enrollment

    Time frame: Liuwei Dihuang Pills therapy(up to six months)

07

Study locations

1 of 1 sites recruiting
  • Fujian Academy of Trational Chiness Medicine
    Fuzhou, Fujian 350003, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02981732
Lead sponsor
xuhuijuan
Responsible party
xuhuijuan (Fujian Academy of Traditional Chinese Medicine, Fujian Academy of Traditional Chinese Medicine) — Sponsor-investigator
First posted
Dec 5, 2016
Start date
Oct 2016
Primary completion
Mar 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Mar 27, 2017

Study contacts

Yao xin
Contact
yjyllbgs@163.com
0591-83570813
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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