Clinical trial NCT01834105: Molecular Mechanism of POP Kidney Yin Deficiency Syndrome From the Interventional Effects of CLCF1
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal osteoporosis; Kidney Yin deficiency syndrome; Liuwei dihuang pill; CLCF1; JAK - STAT signal pathway
Lead sponsor: Fujian Academy of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 25
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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;

Primary outcomes:
measure: osteoporosis treatment within six months of study enrollment
timeFrame: Liuwei Dihuang Pills therapy (up to six months)
Secondary outcomes:
Other outcomes:
Locations:
city: Fu Zhou
country: China
facility: Fujian Institute of Trational Chiness Medicine
state: Fujian
Study officials:
References: