Postmenopausal Osteoporosis
Conditions
Interventions
Control Group:Alphadi tricalciferol softgels (produced by Oz Pharmaceutical Co. Ltd. approval number: J20171090) 0.25µg 2 capsules/time 1 time/d
Observation Group:Alphadi tricalciferol softgels (produced by Oz Pharmaceutical Co. Ltd. approval number: J20171090) 0.25µg 2 capsules/time 1 time/d and Oral Lingxian Powder Chinese Medicine Decoction
Sponsors
Second Affiliated Hospital of Zhejiang University of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
Female
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of "osteoporosis" or "osteopenia" in Western medicine and "spleen and kidney deficiency" in traditional Chinese medicine; (2) Age over 50 years old female menopause for more than 1 year or more; (3) No history of chronic diseases and major diseases no immunodeficiency; (4) The physical examination before the test showed that the subject's subjective feelings eating physiological indicators (symptoms and signs such as blood pressure and heart rate) blood routine blood biochemistry (aminotransferases serum total protein albumin urea creatinine blood lipids blood glucose etc.) physical examinations (chest X-ray electrocardiogram abdominal B-ultrasound examination) were normal; (5) Patients with normal intellectual status and cognitive function who can understand the "Postmenopausal Women's "Spleen and Kidney Deficiency" Syndrome Symptom Score Questionnaire (Agreement Version C); (6) Voluntarily participate in the investigation of the symptoms of "spleen and kidney deficiency" in the intervention of Lingxian San and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who cannot eat orally or cannot take the test drug according to the regulations; (2) Those who are intolerant or allergic to the drug; (3) Patients who could not understand the "Postmenopausal Women's "Spleen and Kidney Deficiency" Syndrome Symptom Score Questionnaire (Agreement Version C); (4) Patients with serious diseases such as multi-system or intellectual disability or mental illness; (5) Incomplete data that affect the efficacy or drug safety judgment of Lingxian San; (6) Taking food or drugs similar to Lingxian powder or related to bone metabolism in a short period of time will affect the judgment of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| type I procollagen amino-terminal peptide, PINP; type I collagen ß-carboxy-terminal peptide, ß-CTX; bone-specific alkaline phosphatase, BALP; tartrateresistant acidphosphatase, TRACP; osteoprotegerin, OPG; receptor of activator of NF-?B ligand, RANKL; | — |
Secondary
| Measure | Time frame |
|---|---|
| Follicle Stimulating Hormone, FSH; Luteinizing Hormone, LH;Progesterone, P;Estradiol, E2;Testosterone, T; Prolactin, PRL;Transforming Growth Factor-beta, TGFß; Tumor Necrosis Factor-alpha, TNFa; Interleukin17A, IL17A; Interleukin 10 ,IL 10; Interleukin 1ß, IL1ß; Interleukin 6, IL6; Interferon gamma, IFN?;TCM syndrome score of spleen and kidney deficiency;TCM tongue image; | — |
Countries
China
Contacts
Public ContactYu Yikang
Zhejiang Chinese Medical University
Outcome results
None listed