Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01940380
Other study ID # 20130305
Secondary ID
Status Completed
Phase N/A
First received September 4, 2013
Last updated March 20, 2017
Start date September 2013
Est. completion date December 9, 2016

Study information

Verified date March 2017
Source Fujian Academy of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a deterioration of the bone architecture resulting in an increased risk of fracture,which is directly related to the lack of estrogen and also associated with a variety of genetic and acquired factors. Previous studies have found that POP molecular regulation mechanism of kidney Yang deficiency syndrome may be associated with LTBP1 gene expression.

This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 9, 2016
Est. primary completion date December 1, 2013
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


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Fujian Academy of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postmenopausal Osteoporosis of kidney Yang deficiency syndrome To observe the changes in gene expression(Day 1)