Blood and Lymph Conditions

All Conditions

Lymphedema

Lymphatic Diseases

Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.

Aescuven Forte oral tablet 150mg (2 capsules/time, 2 times daily) and gradient compression stockings.

150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.

Daphnetin

150mg (2 capsules/time, 2 times daily) and gradient compression stockings.

Aescuven

Xiaosen Li Li

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.

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.

female after gynaecological malignancy surgery

Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery

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

The patient was in the supine position with both lower limbs relaxed. The clinician measured the limb circumference at the dorsum of the foot, the lateral malleolus, the upper edge of the patella and 10 cm above and below with a tape measure and calculated the difference in limb circumference between the two lower limbs.

The GCLQ has good reliability and validity and is easy to administer. It is widely used in the diagnosis and assessment of lower extremity lymphoedema. The questionnaire consisted of 20 questions scored on 7 dimensions: heaviness, oedema (global), swelling (local), numbness, infection, pain and limb function. The answer 'yes' to each question was worth 1 point and the answer 'no' was worth 0 point. A total score of ≥4 points was considered to be lower limb lymphedema (see Appendix II).

2ml of peripheral venous blood was collected from patients and stored in EDTA anticoagulant test tubes. FIB was detected by automatic haemagglutination analyser (STAGO MAXR) in the laboratory department of our hospital.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery	NCT06329167	Lower Extremity...	Daphnetin Aescuven	18 Years - 75 Years	The First Hospital of Jilin University
Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery	NCT06329167	Lower Extremity...	Daphnetin Aescuven	18 Years - 75 Years	The First Hospital of Jilin University

Spots Global Cancer Trial Database for gynaecological malignancy surgery