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To explore the clinical effect of Gubao pill on postmenopausal osteoporosis based on "kidney main bone"

To explore the clinical effect of Gubao pill on postmenopausal osteoporosis based on "kidney main bone"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000303
Enrollment
Unknown
Registered
2024-08-26
Start date
2024-08-27
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Postmenopausal osteoporosis

Interventions

Control group:Oral calcium carbonate D3 tablets and alendronate enteric-coated tablets 1 time a week
Treatment group:In the control group routinely On the basis of treatment, add Gubao Pill decoction

Sponsors

Foshan Women And Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Women aged 50-65 who have been naturally postmenopausal and have been menopausal for at least 2 years; (2) Meet the diagnostic criteria of PMOP in Western medicine and exclude patients with severe OP; (3) Meet the diagnostic criteria of spleen, yin and yang deficiency syndrome in traditional Chinese medicine; (4) The subjects have clear thinking, good communication and compliance, and can cooperate well with data collection; (5) The subject meets the above diagnostic criteria and voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) The subject has used hormones or other drugs that affect bone metabolism within half a year; (2) The subject's bones are deformed and he loses his ability to work; (3) The subject suffers from severe orthopedic surgery sequelae, trauma or scoliosis and other diseases that affect bone densitometry; (4) The subject suffers from skeletal system diseases such as vertebral tuberculosis; (5) Subjects have diabetes, hyperparathyroidism and other diseases that may lead to secondary osteoporosis; (6) Subjects have serious diseases such as cardiovascular and cerebrovascular, liver and kidney, or blood system; (7) Subjects with psychiatric disorders or other disorders that affect compliance; (8) Patients with malignant tumors; (9) People who are addicted to tobacco and alcohol and have allergies.

Design outcomes

Primary

MeasureTime frame
Bone mineral density;

Secondary

MeasureTime frame
Complete blood count;Quality of life rating scale SF-36 score;Kidney function;VAS pain score;Four vital signs;TCM symptom scale score ;Urinalysis;Fecal routine;Hamilton Anxiety Inventory (HAMA) score;Liver function;

Countries

China

Contacts

Public Contactliyi

Foshan Women And Children Hospital

820319421@qq.com13823463216

Outcome results

None listed

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