Clinical trial NCT06310538: Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on Real World
Official title: Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Hyperplasia
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Investigators adopte a real-world prospective cohort study design to investigate the efficacy and safety of the Kou Sha therapy in the treatment of breast hyperplasia.Kou sha on the key points of breast diseases can dredge the mammary veins, and scraping on the back of the liver, gall bladder, spleen, and stomach can loosen the liver and diarrhea, dredge the internal organs and meridians, regulate emotions, and facilitate the recovery of breast hyperplasia.

Eligibility criteria: Inclusion Criteria:

* It meets the diagnostic criteria of breast hyperplasia, and the course of disease is more than 3 months;
* Female, aged between 18 and 50, with regular menstrual cycle and period, with menstrual cycle of (28±7) d;
* Mild and moderate breast pain, with BI-RADS grade below 4;
* Informed consent, voluntary subjects and signed informed consent.

Exclusion Criteria:

With one of the following circumstances cannot be included in this experimental study:

* Patients with breast malignant tumor, inflammatory disease and other breast diseases;
* Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system are psychotics;
* prepare for women during pregnancy, pregnancy, lactation, menopause, severe menstrual cycle disorder or functional uterine bleeding;
* Severe diabetes, skin trauma or obvious inflammation, redness and ulceration of the skin;
* Diseases with severe bleeding tendency, such as thrombocytopenia, leukemia and allergic purpura;
* Those who are using Chinese and western medicines (including topical medicines, acupuncture, etc.) for the treatment of breast hyperplasia within one month before this treatment or now, and have not used hormonal drugs within half a year;
* Participants in other clinical trials within 3 months.

Primary outcomes:
measure: Breast pain score
timeFrame: 1 month
measure: Short Form McGill Pain Inquiry Scale (SF-MPQ)
timeFrame: 1 month
Secondary outcomes:
measure: Breast color ultrasound score
timeFrame: 1 month
measure: Palpation lump score
timeFrame: 1 month
measure: Depression symptoms
timeFrame: 1 month
measure: Anxiety symptoms
timeFrame: 1 month
measure: The quality of life rating scale (QOL)
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References: