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

Postmenopausal Osteoporosis Clinical Trial

— pop  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01834105
• Other study ID #: 81173280
• Status: Recruiting
• Phase: Phase 2
• First received: April 14, 2013
• Last updated: April 17, 2013
• Start date: January 2012

Study information

• Verified date: April 2013
• Source: Fujian Institute Of Trational Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis
• Yin Deficiency

Intervention

Drug:
• Liuwei Dihuang Pills

Locations

Country	Name	City	State
China	Fujian Institute of Trational Chiness Medicine	Fu Zhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Institute Of Trational Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	osteoporosis treatment within six months of study enrollment		Liuwei Dihuang Pills therapy (up to six months)	Yes