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

NCT01834105 | Unknown Phase 2 DMC

• 1 other identifier: 81173280
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Osteoporosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• osteoporosis treatment within six months of study enrollment

  Liuwei Dihuang Pills therapy (up to six months)

Study Arms (1)

Liuwei Dihuang Pills

EXPERIMENTAL

Drug: Liuwei Dihuang Pills

Interventions

Liuwei Dihuang Pills DRUG

Liuwei Dihuang Pills

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fujian Academy of Traditional Chinese Medicine: lead

Study Sites (1)

Fujian Institute of Trational Chiness Medicine

Fuzhou, Fujian, 3530003, China

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Crisponi syndrome

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: April 17, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Last Updated: April 18, 2013

Record last verified: 2013-04

Locations

CN (1)