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The Clinical Study of Erzhi pill for Menopausal Osteoporosis

A Randomized, Controlled Trial of Erzhi pill for Menopausal Osteoporosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013000
Enrollment
Unknown
Registered
2017-10-16
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-10-23

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

Conditions

Osteoporosis in Menopausal Women

Interventions

group A:erzhi pill
groupB:Caltrate

Sponsors

Second Affiliated Hospital of Tianjin University  of TCM
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. femal aged 45 to 65 years old,during the period of perimenopause or early postmenopause (less than 5years); 2. Osteoporosis was diagnosed; 3. liver and kindey yin-deficiency; 4. informed consent form has been signed.

Exclusion criteria

Exclusion criteria: 1. Secondary Osteoporosis or Idiopathic osteoporosis; 2. Surgical menopause; 3. Known hypersensitivity to the investigational drugs or their ingredients; 4. Patients with diseases as follows: malignant tumor; hyperthyroidism, hypothyroidism, uncontrolled diabetes; obesity (body mass index greater than 30); neurasthenia, psychiatric disorders, migraine headache; hematopoietic system diseaseautoimmune system diseases; Fungal or bacterial vaginal infections; Hypercalcemia; 5. Abnormal liver function or abnormal renal function; 6. The participants used the same treatment of traditional Chinese medicine in the previous 4 weeks. Use Estrogen or estrogen/progesterone drugs through vaginal or percutaneous or oral style in the previous 8 weeks. Take progesterone implants and a separate injection of estrogen therapy in the previous 3 months, Take estrogen pills or progesterone injection in the previous 6 months; 7. patients with severe osteoporosis and fracture,or deformity, loss of labor force.

Design outcomes

Primary

MeasureTime frame
Menopause-specific quality-of-life (MENQOL);bone density;

Secondary

MeasureTime frame
Osteoporosis symptom rating scale;FSH, E2, Testosterone;Blood calcium,Blood phosphorus ,ALP;

Countries

China

Contacts

Public ContactGao Xiumei

Second Affiliated Hospital of Tianjin University of TCM

gaoxiumei@tjutcm.edu.cn+86 13602020716

Outcome results

None listed

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