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Clinical validation of therapeutic efficacy that Qing'e pill reduces the risk of osteoporotic fractures in postmenopausal women

Clinical validation of therapeutic efficacy that Qing'e pill reduces the risk of osteoporotic fractures in postmenopausal women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003969
Enrollment
Unknown
Registered
2013-11-13
Start date
2013-12-05
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporosis

Interventions

experimental group:Qingewan+Caltrate With Vitamin D Tablets
control group:Qingewan simulant+Caltrate With Vitamin D Tablets

Sponsors

Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Post-menopausal women, natural menopause more than 1 year, age </= 65; If have surgery, FSH <40ng/ml; 2. With a typical clinical symptoms of osteoporosis, meet the diagnostic criteria of osteoporosis; 3. Meet the diagnostic criteria that kidney deficiency and blood stasis syndrome; 4. Subjects was in the context of informed consent and sign the relevant document.

Exclusion criteria

Exclusion criteria: (1) Do not meet the diagnostic criteria of medicine and traditional Chinese medicine; (2) Natural menopause less than 1 year; (3) Age> 65 years; (4) Recent fracture within 6 months; (5) The patient of hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma, diabetes, osteoporosis and other serious complications; (6) Severe kyphosis, disability and incapacitated person; (7) Within three months, in addition to calcium and vitamin D, the patient who had used hormone, parathyroid hormone, bisphosphonates, calcitonin, glucocorticoids and other drug of which affecting bone metabolism; (8) Patients with severe kidney disease, such as liver function (AST, ALT) were 1.5 times higher than the upper limit of normal persons, total bilirubin were 2 times greater than the upper limit of normal persons, renal function BUN were 1.1 times higher than the upper limit of normal persons, Cr was higher than the upper limit of normal persons, the patient who was diagnosed with Kidney calculus, kidney crystallization by B ultrasound; (9) Allergic to the ingredient in this drug; (10) Patients with mental illness; (11) The researchers those who participate in this research.

Design outcomes

Primary

MeasureTime frame
bone mineral density;Bone metabolism index;

Secondary

MeasureTime frame
pain score;

Countries

China

Contacts

Public ContactZhao yongfang

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

zhao_dingding@126.com+86 021-20256185

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026