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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients aged 18 to 75 years (including cut-off) with lower limb lymphoedema (stage I-II) following gynaecological surgery for a malignant tumour without temporary surgical treatment.

• There was no preoperative lymphedema

• Voluntarily sign consent form

• The performance status score had to be 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG).

• Investigator-assessed expected survival ≥12 weeks

• Not receiving any other treatment for lower limb lymphoedema

• Have adequate organ and bone marrow reserve function

• Be able to understand the requirements of the trial and be willing and able to follow the trial and follow-up procedures

Locations
Other Locations
China
the 1st hospital of Jilin University
RECRUITING
Changchun
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 100
Treatments
Experimental: Daphnetin treatment group
Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.
Active_comparator: Aescuven Forte group
Aescuven Forte oral tablet 150mg (2 capsules/time, 2 times daily) and gradient compression stockings.
Related Therapeutic Areas
Sponsors
Leads: The First Hospital of Jilin University

This content was sourced from clinicaltrials.gov