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To explore the clinical efficacy and multi-omics study of Bushen Jianpi Huoxue recipe in the prevention and treatment of postmenopausal osteoporosis under the guidance of the theory of "kidney deficiency as the main factor, deficiency and blood stasis as the main factor"

To explore the clinical efficacy and multi-omics study of Bushen Jianpi Huoxue recipe in the prevention and treatment of postmenopausal osteoporosis under the guidance of the theory of "kidney deficiency as the main factor, deficiency and blood stasis as the main factor"

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086885
Enrollment
Unknown
Registered
2024-07-15
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

postmenopausal osteoporosis

Interventions

Conventional treatment group:Conventional anti-osteoporosis treatment
Bushen Jianpi Huoxue decoction + conventional treatment group:On the basis of conventional treatment, Bushen Jianpi Huoxue decoction was given orally
Normal group:Volunteers without osteoporosis were recruited without any intervention.

Sponsors

The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Normal group into the standard: (1) Patients without diagnosed postmenopausal osteoporosis; (2) Without symptoms of low back pain; (3) Women aged between 55 and 75 years old; (4) Voluntarily participated in this study and signed informed consent. Conventional treatment group \ Chinese medicine intervention group Inclusion criteria: (1) Postmenopausal osteoporosis (postmenopausal osteoporosis diagnostic criteria: ? Dual-energy X-ray absorptiometry, bone mineral density T=-2.5; ?a hip or vertebral body brittle fracture.?bone mineral density low bone mass diagnosis standard merge pelvis, forearm distal or proximal humeral brittle fracture); (2) In line with the "bone impotent" diagnostic criteria of TCM, syndrome differentiation of spleen and kidney deficiency (bone impotent spleen and kidney deficiency type of TCM diagnostic criteria: ?the main symptoms: low back pain, fatigue strength of god. ? Secondary symptoms: not overweight, dizzy, defecate is not adjustable. ? the tongue like: light white or reddish tongue, thin white coating on the tongue. Pulse fine or thin. Disease one or more primary symptom, the necessary time, combined with the tongue veins can be diagnosed.) ; (3) Have the symptoms of low back pain; (4) Women aged between 55 and 75 years old; (5) 6 months did not receive other drug treatment in postmenopausal osteoporosis or other related intervention measures (6) To voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: Normal/regular treatment group/Chinese medicine intervention group exclusion criteria (1) patients with idiopathic osteoporosis; (2) BMI < 18.5; (3) in recent 3 months taking drugs that interfere with bone metabolism (e.g., glucocorticoids, calcitonin, estrogen, etc.); (4) have occurred within 3 months vertebral compression fractures; (5) other diseases cause of low back pain symptoms; (6) late malformation, disability, loss of labor; (7) allergic constitution, and for a variety of drug allergy; (8) patients with severe primary diseases of liver, kidney, hematopoietic system, endocrine system and mental illness;

Design outcomes

Primary

MeasureTime frame
TCM syndrome score;Serum bone metabolism related indicators;intestinal flora;Bone Mineral density (BMD);

Secondary

MeasureTime frame
Visual analogue scale (VAS) was used to evaluate the effect;World Health Organization Quality of Life questionnaire-short form;Fracture risk assessment tool;

Countries

China

Contacts

Public ContactFAN WANG

The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine

540552440@qq.com+86 138 0849 8317

Outcome results

None listed

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