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

Hongguo Rong

Status: Not yet enrolling

Conditions: Breast Hyperplasia

Treatments: Drug: Hongjin Xiaojie Capsules; Behavioral: kou sha

Study type: Interventional

Funder types: Other

Identifiers

NCT06310538

2024BZYLL0110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Kou Sha group

Experimental group

Description:

Generally, the Kou Sha therapy group needs to kou sha 2-3 times, and after each kou sha, it is necessary to rest for 1 week or all the shas in the part fade before they can be kou sha again. The duration of treatment is 1 menstrual cycle.

Treatment:

Behavioral: kou sha

Control group

Active Comparator group

Description:

The control group is treated with conventional Western medicine, and according to the patient's condition, Chinese patent medicine treatment, psychological counseling and lifestyle adjustment are carried out. The duration of treatment is 1 menstrual cycle. Stop all medications during menstruation. During this period, avoid excessive fatigue and mental stimulation, and avoid spicy and irritating foods

Treatment:

Drug: Hongjin Xiaojie Capsules