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Clinical study of Jiawei Yougui pill combined with Jintiange capsule in the treatment of kidney deficiency and blood stasis type OP

Clinical study of Jiawei Yougui pill combined with Jintiange capsule in the treatment of kidney deficiency and blood stasis type OP

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063236
Enrollment
Unknown
Registered
2022-09-02
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Primary osteoporosis

Interventions

Control group A:Tonifying kidney and activating blood soup
The experimental group B:Jintiange capsule
The experimental group C:Jiawei Yougui pill
The experimental group D:Jiawei Yougui pill combined with Jintiange capsule

Sponsors

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the Western diagnostic criteria for primary osteoporosis; 2. Those who meet the TCM syndrome differentiation criteria of kidney deficiency and blood stasis; 3. Symptoms of low back pain, and the average weekly VAS score >= 3; 4. Both sexes. Male aged >= 70 years; Female aged >= 10 years after menopause (menopause is defined as women aged > 40 years who have not had menstruation 12 months after their last menstruation); 5. Sign the informed consent, be willing to accept examination, treatment and cooperate with the visitors.

Exclusion criteria

Exclusion criteria: 1. Secondary osteoporosis (such as osteomalacia, rheumatoid arthritis, gout multiple myeloma and other secondary osteoporosis); 2. OP patients with other TCM syndromes (such as spleen and stomach weakness, liver and kidney Yin deficiency syndrome); 3. Patients with current hyperthyroidism and hypothyroidism, hyperparathyroidism, tumor-induced osteolysis and osteocalcalcinosis; 4. Patients with congestive heart failure diagnosed as class III or IV according to the New York Heart Association (NYHA) classification within the past 12 months; Patients with uncontrolled arrhythmias and unstable coronary heart disease, percutaneous coronary intervention, unstable angina pectoris after coronary artery bypass grafting or stroke within 3 months before screening; 5. Patients with severe liver and renal insufficiency; 6. Previous or current malignant tumor; 7. Allergic constitution, allergic to calcium carbonate D3 tablets, Bushen Huoxue Decoction, Jiawei Yougui pill, Jintiange capsule; 8. Psychogenic low back pain or mental illness that researchers believe cannot be adequately controlled by medication; 9. Other drugs affecting bone metabolism were taken 2 weeks before enrollment, such as Xilinggubao capsule alendronate sodium tablets, teriparatide, raloxifene, calcitonin, etc., and zoledronic acid injection was used within one year before enrollment; 10. Participated in other clinical trials within 1 month; 11. Refuse treatment or fail to cooperate for other reasons.

Design outcomes

Primary

MeasureTime frame
Bone mineral density;TCM syndrome integration;

Secondary

MeasureTime frame
Bone transformation marker;Low back pain ODI score;

Countries

China

Contacts

Public ContactTan Longwang

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

longwangtan@sina.com+86 15991006188

Outcome results

None listed

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