NCT06329167

Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery

Clinical Trial of Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is designed to learn more about treating patients with lower limb lymphoedema following gynaecological surgery. The main question to be answered is To evaluate the efficacy of Daphnetin capsule in the treatment of patients with lower limb lymphedema following gynaecological malignancy surgery. Participants will take Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) orally at the same time as gradient compression stocking treatment. Researchers will compare 150mg Forte tablets (2 capsules/time, 2 times daily) and gradient compression stockings to see if Daphnetin capsule can be used to treat patients with lower extremity lymphedema following gynaecological malignancy surgery.

Detailed description

This study was a randomised, controlled, open-label, single-centre clinical trial. The objective of this study was to determine the efficacy and safety of Daphnetic capsules compared to Aesculete tablets in the treatment of patients with lower extremity lymphedema following gynaecological cancer surgery. A total of 100 patients with postoperative lower extremity lymphedema (stage I-II) following gynaecological cancer surgery were enrolled in this randomised controlled trial. Patients were randomised 1:1 to the experimental or control group. Subjects who met the inclusion and exclusion criteria were randomly allocated to the Daphnetin group (study group) or the Aesculeum aesculeum group (control group) in a 1:1 ratio after signing the informed consent form. Both groups were treated for 21 days as a cycle, and efficacy and safety indices were evaluated after the first course of treatment. Group A: Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings. Group B: Aescuven Forte oral tablet 150mg (2 capsules/time, 2 times daily) and gradient compression stockings.

Conditions

• Lower Extremity Lymphedema

Interventions

Type	Name	Description
DRUG	Daphnetin	150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.
DRUG	Aescuven	150mg (2 capsules/time, 2 times daily) and gradient compression stockings.

Timeline

• Start date: 2024-03-25
• Primary completion: 2025-07-01
• Completion: 2025-07-31
• First posted: 2024-03-25
• Last updated: 2024-03-25

Locations

1 site across 1 country: China