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

Primary Purpose

Postmenopausal Osteoporosis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Liuwei Dihuang Pills
Sponsored by
Fujian Academy of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postmenopausal Osteoporosis focused on measuring Postmenopausal osteoporosis; Kidney Yin deficiency syndrome; Liuwei dihuang pill; CLCF1; JAK - STAT signal pathway

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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;

Sites / Locations

  • Fujian Institute of Trational Chiness MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liuwei Dihuang Pills

Arm Description

Outcomes

Primary Outcome Measures

osteoporosis treatment within six months of study enrollment

Secondary Outcome Measures

Full Information

First Posted
April 14, 2013
Last Updated
April 17, 2013
Sponsor
Fujian Academy of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01834105
Brief Title
Molecular Mechanism of POP Kidney Yin Deficiency Syndrome From the Interventional Effects of CLCF1
Acronym
pop
Official Title
Study on the Molecular Mechanism of Postmenopausal Osteoporosis With Kidney Yin Deficiency Syndrome From CLCF1 Interventing on JAK-STAT Signaling Pathways
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Academy of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Postmenopausal osteoporosis; Kidney Yin deficiency syndrome; Liuwei dihuang pill; CLCF1; JAK - STAT signal pathway

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liuwei Dihuang Pills
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Liuwei Dihuang Pills
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
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
Fujian Institute of Trational Chiness Medicine
City
Fu Zhou
State/Province
Fujian
ZIP/Postal Code
3530003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xie bin ying, Bachelor
Phone
86-0591-83570943
Email
yjykyb@163.com

12. IPD Sharing Statement

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

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