Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastitis: A Prospective Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
To evaluate the efficacy and safety of Sanyong Jiedu Granules in treating non-lactational mastitis with lump formation, and to investigate the relationship between its clinical efficacy and treatment duration.
详细描述
This study is a randomised controlled trial comprising three phases: the screening phase, the treatment phase and the follow-up phase.
- Screening phase: A total of 210 patients with mastitis who were not breastfeeding and met the inclusion and exclusion criteria were enrolled in either the experimental group or the control group, with 70 patients in each of Experimental Group 1, Experimental Group 2 and the control group.
- Treatment phase:
Experimental Group 1: San Yong Jie Du Granules group: San Yong Jie Du Granules were taken with boiled water, 10 g per dose, three times daily, for 56 consecutive days or until symptoms were completely resolved or stabilised;
Experimental Group 2: San Yong Jie Du Granules + guideline-based medication group:
Treatment regimen for plasma cell mastitis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-50 years (inclusive) who are not in lactation or pregnancy (as confirmed
- •Meeting the diagnostic criteria for non-lactational mastitis
- •In the mass phase of non-lactational mastitis, with no surface ulceration or only minor ulceration or microabscesses, but without sinus tract or fistula formation
- •Diagnosed as "exuberant heat-toxin syndrome" in Traditional Chinese Medicine (TCM) syndrome differentiation
- •nformed consent obtained and signed by the subject
排除标准
- •Patients with intolerance or poor compliance to the investigational drug, or known hypersensitivity to any component of this regimen
- •Patients with clinically or laboratory-confirmed severe cardiac, hepatic, or renal dysfunction, or those with severe complications, active infections, persistent fever, severe bleeding tendency, or hematopoietic abnormalities
- •Patients diagnosed with breast cancer by pathological biopsy
- •Confirmed as tuberculous granuloma by pathogen examination
- •Pregnant and lactating women, as well as women of childbearing age who are fertile but unwilling to use effective contraception throughout the trial period
- •A clear history of neurological or psychiatric disorders, including epilepsy or dementia;Suspected or confirmed history of alcohol or drug abuse;Participants deemed unsuitable for the study by the investigators
研究组 & 干预措施
Control Group
Standard Medication
干预措施: Standard Medication (Drug)
Experimental Group 1
Sanyong Jiedu Granules
干预措施: Sanyong Jiedu Granules (Drug)
Experimental Group 2
Combination of Sanyong Jiedu Granules with Standard Medication
干预措施: Sanyong Jiedu Granules (Drug)
Experimental Group 2
Combination of Sanyong Jiedu Granules with Standard Medication
干预措施: Standard Medication (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 4 weeks after taking the medication, 8 weeks after taking the medication
(Complete Response + Partial Response)/Total number of cases × 100%
次要结局
- Lump Size(Baseline, 4 weeks after drug administration and 8 weeks after drug administration)
- NRS Score(Baseline,2, 4, and 8 weeks post-treatment, and 1 and 3 months after discontinuation of medication)
- Course of the disease(Baseline, 2 weeks after medication initiation (D14±3 days), 4 weeks after medication initiation (D28±5 days), and at treatment completion (D56/withdrawal ±7 days))
- Recurrence Rate(Recurrence of disease activity within three months of the end of treatment)
- The total dose of steroid hormones or antibiotics from the initiation to the completion of treatment(The calculation begins on the day of randomization for the subjects (denoted as Day 0) and continues until the completion of treatment (Day 56/withdrawal))
研究者
Caigang Liu
Postdoctoral,Chief Physician
Shengjing Hospital