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Randomized Controlled Trial of Quandu Zhong Capsules in the Treatment of Primary Osteoporosis

Randomized Controlled Trial of Quandu Zhong Capsules in the Treatment of Osteoporosis with Spleen and Kidney Yang Deficiency Pattern

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000573
Enrollment
Unknown
Registered
2025-03-22
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Primary Osteoporosis

Interventions

Intervention group:Quandu Zhong Capsules combined with basic treatment (Calcium Carbonate and Vitamin D3 Tablets Vitamin D Drops Zoledronic Acid Injection)
Control group:Basic treatment (Calcium Carbonate and Vitamin D3 Tablets, Vitamin D Drops, Zoledronic Acid Injection)

Sponsors

Sichuan Provincial People's Hospital University of Electronic Science and Technology of China Chengdu China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnostic criteria of primary osteoporosis in both traditional Chinese medicine and Western medicine and have been diagnosed with primary osteoporosis; (2) Those with a Numerical Rating Scale (NRS) score of = 4 points; (3) Those aged between 50 and 90 years old regardless of gender; (4) Those who have not received regular anti-osteoporosis treatment in the past year; (5) Those who voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who are allergic to the drugs in this trial protocol or have severe adverse reactions; (2) Those with contraindications to the medication such as renal insufficiency hypocalcemia etc.; (3) Those suffering from progressive malignant tumors and/or other major diseases of other systems such as severe cardiovascular and cerebrovascular diseases digestive system diseases nervous system diseases etc.; (4) Patients with secondary osteoporosis; (5) Those who are currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Numerical Rating Scale;

Secondary

MeasureTime frame
Bone Mineral Density;Pittsburgh Sleep Quality Index;Traditional Chinese Medicine Syndrome Score;Hamilton Anxiety Scale;Manual Muscle Testing;Hamilton Depression Scale;Bone Turnover Markers;36-Item Short-Form;Berg Balance Scale;

Countries

China

Contacts

Public ContactYun Zhang

Sichuan Provincial People's Hospital University of Electronic Science and Technology of China Chengdu China

cry261979@126.com+86 189 8183 8369

Outcome results

None listed

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