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A randomized double-blind placebo-controlled multicenter clinical trial of Danlu Capsules for improving anxiety and symptoms of breast hyperplasia

A randomized double-blind placebo-controlled multicenter clinical trial of Danlu Capsules for improving anxiety and symptoms of breast hyperplasia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001175
Enrollment
Unknown
Registered
2025-06-14
Start date
2025-06-19
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

breast hyperplasia

Interventions

TREATMENT:Oral Danlu capsule placebo, 2.0 g/ time, 3 times/day. The total course of treatment was 8 During the menstrual period, the medication was stopped, and no anti-anxiety and depression drugs an
CONTROL:Oral Danlu capsule placebo 2.0 g/ time 3 times/day. The total course of treatment was 8 During the menstrual period the medication was stopped and no anti-anxiety and depression drugs and anal

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: A. Women over 18 years and under 65 years of age; B. conform to the western medical diagnostic criteria of breast hyperplasia; C. Hama score of 15-29 lasting for more than 2 weeks; D. Signed informed consent.

Exclusion criteria

Exclusion criteria: A. Patients with acute mastitis benign or malignant breast tumors or other breast-related diseases; B. Patients with a history of breast trauma or surgery; C. Patients with pancreatitis or other conditions causing chest pain; D. Pregnant or lactating women; E. Patients with severe cardiac hepatic or renal dysfunction (ALT AST = 1.5 × ULN); F. Patients with a known allergic constitution or hypersensitivity to any component of the study drugs; G. Patients with a prior confirmed diagnosis of anxiety or depression as re-evaluated by a board-certified psychiatrist specializing in brain disorders. Seventeen patients scored above 7 on the HAMD depression scale.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Scale Score;

Secondary

MeasureTime frame
Visual Analog Scale Score;Improved Kupperman score;Serum stress-induced internal environment indicators;Chinese medicine symptom complex score;sex hormones;

Countries

CHINA

Contacts

Public ContactYAO Chang

Jiangsu Province Hospital of Chinese Medicine

yaochang67@126.com18915999830

Outcome results

None listed

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