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

April 17, 2013 updated by: Fujian Academy of Traditional Chinese Medicine

Study on the Molecular Mechanism of Postmenopausal Osteoporosis With Kidney Yin Deficiency Syndrome From CLCF1 Interventing on JAK-STAT Signaling Pathways

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fu Zhou, Fujian, China, 3530003
        • Recruiting
        • Fujian Institute of Trational Chiness Medicine
        • Contact:
          • xie bin ying, Bachelor
          • Phone Number: 86-0591-83570943
          • Email: yjykyb@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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:

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liuwei Dihuang Pills
Drug: Liuwei Dihuang Pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
osteoporosis treatment within six months of study enrollment
Time Frame: Liuwei Dihuang Pills therapy (up to six months)
Liuwei Dihuang Pills therapy (up to six months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Academy of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

April 14, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Estimate)

April 18, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81173280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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