Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-25 @ 3:15 AM
NCT ID:
NCT01834105
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;
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT01834105
Study Brief:
Protocol Section:
NCT01834105