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Status unknownNCT01834105popUpdated Apr 18, 2013

Molecular Mechanism of POP Kidney Yin Deficiency Syndrome From the Interventional Effects of CLCF1

A Phase 2 interventional study of Liuwei Dihuang Pills in Postmenopausal Osteoporosis, sponsored by Fujian Academy of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to female participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-18.

Sponsored by Fujian Academy of Traditional Chinese Medicine · Phase 2, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
Female
01

Study summary

This study use RT-PCR and Western Blot technique to detect the expression of CLCF1 mRNA and protein in POP Kidney Yin deficiency group and healthy group to verify the relevance between CLCF1 and POP the kidney Yin deficiency syndrome.Through siRNA and overexpression,observe the mRNA and protein 's expression of CBP、JAK1、STAT4 and the protein phosphorylation of JAK1、STAT4 in JAK-STAT signal to reveal the CLCF1 regulate the CBP's mechanism.Use the Liuwei Dihuang Pills to detect the effect of treatment ,compare use or not the Liuwei Dihuang Pills to detect the mRNA and protein 's expression of CLCF1、CBP etc.Aim to clarify the POP kidney Yin deficiency molecular mechanism.

02

Conditions studied

  • Postmenopausal Osteoporosis

Keywords

  • Postmenopausal osteoporosis; Kidney Yin deficiency syndrome; Liuwei dihuang pill; CLCF1; JAK - STAT signal pathway
03

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 25 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Fujian Academy of Traditional Chinese Medicine is the lead sponsor of 4 studies on the registry; none are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent.
  • Female ages 45 to 75 had gone through natural menopause before two years
  • In accordance with the western medicine diagnostic criteria of osteoporosis and belong to kidney Yin deficiency syndrome differentiation of traditional Chinese medicine certificate;
  • In accordance with the western medicine diagnostic criteria;
  • In accordance with TCM diagnostic methods; .If any of the above answers are no, The subjects couldn't in the study.

Exclusion criteria

Exclusion Criteria:

  • Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods
  • Age: \<44 and > 76 years old;
  • With hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma and other serious complications such as secondary osteoporosis; Late or deformity, disability, loss of labor;
  • With cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases;
  • Psychosis or alzheimer's patients;
  • Nearly three months, the use of hormone replacement therapy (HRT) and taking calcitonin, nearly six months has used double phosphonic acid salt for 15 days, etc.;
  • This medicine allergic constitution or composition of known to have allergies;
  • In a critical condition, It's difficult to make exact evaluators to efficacy and safety of the new drugs;
05

Study design

Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Liuwei Dihuang Pills

    Drug: Liuwei Dihuang Pills

Interventions

  • DrugLiuwei Dihuang Pills
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 Institute of Trational Chiness Medicine
    Fu Zhou, Fujian 3530003, China
    • xie bin ying, Bachelor · Contact · yjykyb@163.com · 86-0591-83570943
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01834105
Lead sponsor
Fujian Academy of Traditional Chinese Medicine
Responsible party
Sponsor
First posted
Apr 17, 2013
Start date
Jan 2012
Primary completion
Dec 2014 (estimated)
Last update
Apr 18, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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