drugset / Trial / NCT06310538

Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on Real World

NCT06310538 ↗

Unknown 60 enrolled Hongguo Rong
Non-randomizedParallel-groupOpen-labelTreatment

Summary

In this study, epidemiological prospective real-world cohort study design was adopted. The Third Affiliated Hospital of Beijing University of Chinese Medicine and the First Hospital of Handan City, Hebei Province were selected. From the same time appointed before the study, all breast hyperplasia participants who met the admission criteria choosing Kou Sha therapy or routine treatment of western medicine were selected in the sample hospitals.The first 30 participants were included in the planned Kou Sha therapy group while the first 30 participants were included in the control group.Taking the change of the total score of breast pain (McGill Pain Questionnaire Short Form score+breast pain score) as the main curative effect index, and taking McGill pain questionnaire score, breast color ultrasound score, palpation lump score, quality of life, anxiety and depression symptoms, sleep and so on as the secondary curative effect indexes to observe the clinical effect of the method of Kou Sha therapy on breast hyperplasia. The research period is from March 2024 to May 2024.

Timeline

Start
2024-03
Primary completion
2024-05
Completion
2024-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hongjin Xiaojie Capsules Traditional medicine (herbal / TCM) — —

Indications