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Clinical Efficacy and Mechanism of Warm Kidney and Strengthen Bone Formula in Treating Yang Deficiency OP Based on TCM Constitution Theory

Clinical Efficacy and Mechanism of Warm Kidney and Strengthen Bone Formula in Treating Yang Deficiency OP Based on TCM Constitution Theory

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001472
Enrollment
Unknown
Registered
2026-06-10
Start date
2025-04-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Osteoporosis

Interventions

Control Group:Control Group (Routine Anti-Osteoporosis Group): Health education + Caltrate (Wyeth) 1200mg/night + Rocaltrol (Qingdao Zhengda Haier) 0.25ug twice daily for 12 weeks.
Treatment group:Control group treatment ,daily Warm Kidney and Strengthen Bone Formula decoction:Curculigo 10g, Epimedium 10g, Morinda 15g, Angelica 10g, Phellodendron 10g, Anemarrhena 6g, Rehmannia 1

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet diagnostic criteria for osteoporosis and TCM Yang Deficiency constitution. 2. Age 45-75, any gender, no physical disabilities, normal cognitive function. 3. Provide informed consent, comply with daily Warm Kidney and Strengthen Bone Formula decoction intake. Informed consent process must comply with GCP regulations.

Exclusion criteria

Exclusion criteria: (1) Exclusion criteria: 1)Rheumatoid arthritis, chronic renal failure, liver disease, myeloma, hyperthyroidism, hyperparathyroidism, malabsorption, pernicious anemia, AIDS, or long-term use of steroids/anticonvulsants/anti-gonadotropin/thyroxine. 2) Organic diseases of heart, brain, blood vessels, nerves, or endocrine systems (e.g., diabetes, coronary heart disease, hypertension, cor pulmonale). 3) Conditions causing low back pain (e.g., lumbar disc herniation, spinal stenosis, spinal tumors/tuberculosis). (2) Exclude pregnant/lactating/menstruating women; (3) Exclude patients unable to understand/implement treatment;

Design outcomes

Primary

MeasureTime frame
Yang Deficiency Constitution Symptom Score;Limb Mobility Score;—

Secondary

MeasureTime frame
Bone Mineral Density (BMD);Bone Metabolism Markers (calcium,phosphorus,type 1 procollagen amino terminal peptide,ß cross-linked C-telopeptide of type 1 collagen);—

Countries

China

Contacts

Public ContactChen Shizhou

Jiangsu Provincial Hospital of Traditional Chinese Medicine

waitingforyou1216@163.com8618260095729

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026