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:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02981732
Eligibility Criteria:
Inclusion Criteria:
* Patients were included if they were female Han Chinese patients who had undergone natural menopause at least 2 years prior and
* met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis"
* met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine"
* provided informed consent, which was approved by the Fujian Academy of Traditional Chinese Medicine Clinical Research Ethics Committee
Exclusion Criteria:
* patients who did not meet the diagnostic criteria for osteoporosis or CM standards
* patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
* patients with abnormal liver and/or Shen function test results
* patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
46 Years
Maximum Age:
75 Years
Study:
NCT02981732
Study Brief:
Protocol Section:
NCT02981732