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Treatment of Bone Metastasis in Lung Cancer with Ba Wei Ai Gu Ning Granules,a Prospective Multicenter Randomized Double-blind Controlled Study

Treatment of Bone Metastasis in Lung Cancer with Ba Wei Ai Gu Ning Granules,a Prospective Multicenter Randomized Double-blind Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080798
Enrollment
Unknown
Registered
2024-02-07
Start date
2024-02-19
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

lung cancer

Interventions

Treatment group:Bone protective treatment + Ba Wei Ai Gu Ning Granules
Control group:Bone protective treatment + Ba Wei Ai Gu Ning placebo

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Histological or cytological diagnosis of lung malignancy. (2) Age =18 years and =80 years, regardless of gender. (3) Evidence of one or more osteolytic bone metastases based on imaging (MRI/CT/bone scan) within the past 3 months prior to enrollment. (4) Serum calcium level corrected to =2.0mmol/L and =2.9mmol/L within the past 1 month prior to enrollment. (5) Performance status (ECOG) score of 0-2. (6) Traditional Chinese Medicine (TCM) syndrome differentiation indicating spleen and kidney deficiency. (7) Understanding and willingness to participate in the study by signing an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with multiple primary cancers. (2) Patients with severe primary diseases affecting the heart, cerebrovascular system, liver, kidney, hematopoietic system, etc. (3) Patients with unhealed oral surgery. (4) Patients known to be allergic to the components of this Chinese herbal medicine. (5) Patients planning to undergo other traditional Chinese medicine treatments or bone treatments. (6) Patients who have received previous treatment with strontium-89.

Design outcomes

Primary

MeasureTime frame
The incidence of bone-related adverse events;

Secondary

MeasureTime frame
The time of occurrence of bone-related adverse events;Quality of life;Symptoms of lung cancer;Pain;Progress Free Survival;Overall Survival;Biochemical markers related to bones;

Countries

China

Contacts

Public ContactGong Yabin

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of traditional Chinese Medicine

gongyabin@shutcm.edu.cn+86 189 1892 3873

Outcome results

None listed

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