Skip to content

A randomized controlled, double-blind, multicenter study of Bushen Yijing formula for the treatment of primary osteoporosis with kidney essence deficiency

A randomized controlled, double-blind, multicenter study of Bushen Yijing formula for the treatment of primary osteoporosis with kidney essence deficiency

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083803
Enrollment
Unknown
Registered
2024-05-04
Start date
2023-08-08
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

primary osteoporosis

Interventions

treatment group:Basic treatment+Bushen Yijing Formula granules
Control group:Basic treatment+placebo of Bushen Yijing Formula granules

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria of primary osteoporosis, as well as TCM diagnosis of kidney essence deficiency; 2. Male and female patients aged 45 years old = age <80 years old; 3.Sign the informed consent form, willing to accept the examination, treatment and can cooperate with the follow-up; 4.Not accept any other treatment options.

Exclusion criteria

Exclusion criteria: 1. Allergic body; 2. Secondary osteoporosis such as hyperparathyroidism, osteochondrosis, rheumatoid arthritis, gout, multiple myeloma and other secondary osteoporosis patients with a variety of endocrine diseases (such as Cushing's disease, hyperthyroidism, hyperthyroidism, hypothyroidism, diabetes mellitus, etc.); 3. Other serious diseases affecting bone metabolism; 4. Mental illness; 5. Combined with fracture need to be Surgical treatment; 6. Long-term concomitant use of other drugs affecting bone metabolism, which can not be immediately discontinued; 7. Late deformity, disability, loss of labour; 8. Breastfeeding women during pregnancy.

Design outcomes

Primary

MeasureTime frame
Bone mineral density;Biochemical markers of bone metabolism;

Secondary

MeasureTime frame
VAS score for lower back pain and lower limb;Oswestry disability index scores of lumbar;ECOS-16 Quality of Life Questionnaire;TCM syndrome score;FRAX Score;Number of fractures;

Countries

China

Contacts

Public ContactDezhi Tang

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

lhyllb@163.com+86 21 6438 5700

Outcome results

None listed

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