Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Breast pain score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Kou Sha group
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.
干预措施: kou sha (Behavioral)
Control group
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
干预措施: Hongjin Xiaojie Capsules (Drug)
结局指标
主要结局
Breast pain score
时间窗: 1 month
①Pain score: 0 points for no breast pain, 2 points for mild breast pain, no feeling when not deliberately felt, and no work and life are affected, 4 points for frequent but frequent breast pain that can be tolerated, and slightly affected work and life are counted as 4 points, and obvious persistent breast pain that is unbearable and difficult to work and life to carry out normally is counted as 6 points. ②Tender pain score: 0 points for no tenderness, 3 points for slight discomfort after touching and pain after repressing, 6 points for moderate tenderness after touching and aggravation of pain after repressing, obvious pain after touching and pain after slight pressing, and 9 points for unconsciously avoiding pain due to pain when the doctor examines the body. The higher the score, the worse the result.
Short Form McGill Pain Inquiry Scale (SF-MPQ)
时间窗: 1 month
The higher the score, the worse the result.The scale is divided into 3 parts: ①The pain grading index (PRI) includes 11 sensory words and 4 emotional words, and the degree is divided into 4 levels: none, mild, moderate and severe, with 0, 1, 2 and 3 points, including feeling score (0\~36 points) and emotional score (0\~9 points), and the PRI sensory score, emotional score and total score can be calculated. ②The visual analogy grading method (VAS) is a 10 cm long straight line, with the two ends representing no pain (0 points) and severe pain (10 points) respectively, in which the patient marks the degree of pain. ③The existing pain intensity (PPI) is divided into 6 grades: no pain, mild discomfort, discomfort, uncomfortable, terrible pain, and extreme pain, with a score of 0, 1, 2, 3, 4, and 5, respectively.
次要结局
- The quality of life rating scale (QOL)(1 month)
- Depression symptoms(1 month)
- Anxiety symptoms(1 month)
- Palpation lump score(1 month)
- Breast color ultrasound score(1 month)
研究者
Hongguo Rong
Investigator
Beijing University of Chinese Medicine