Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 472
- 主要终点
- Success rate of the investigators' overall assessment (IGA) for acne vulgaris
研究概览
简要总结
We designed the study as a double-blind,randomized,controlled clinical trial.The aim of this trial is to clarify the treatment efficacy, safety, and recurrence control of BaiDi QuZhi(BDQZ) granule combined with Ju Yin(JY) cream in the treatment of acne vulgaris.
详细描述
Acne is a chronic inflammatory skin disease of hair follicle and sebaceous gland, which is common in adolescents and adults.Systemic drugs commonly used in the treatment of acne include isotretinoin, oral antibiotics and hormone preparations. Isotretinoin is the first choice for the treatment of moderate and severe acne, but its use is limited by its adverse reactions such as cheilitis, elevated blood lipids and teratogenicity .The efficacy of BDQZ granule in the treatment of acne is accurate. However, large-scale randomized controlled trials have not been conducted on the efficacy, safety and recurrence of BDQZ granule. Therefore, our aim was to conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial of oral BDQZ granule combined with JY cream in the treatment of acne vulgaris.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acne vulgaris aged from 16 to 45, male or female.
- •Patients who meet the western diagnostic criteria of mild and moderate acne vulgaris and the differentiation criteria of TCM syndrome (15,16).
- •Patients who voluntarily join this study with informed consent.
- •No acne drugs were received within 1 month, and no external drugs related to the disease were used within 1 week.
排除标准
- •Patients with severe primary diseases such as cerebrovascular, cardiovascular, liver, kidney and hematopoietic system.
- •Participants will be ineligible if they ate pregnant or lactating women, and those with fertility plans in the next 2 years.
- •Patients who do not meet the inclusion criteria, fail to use the medicine according to the regulations, fail to judge the curative effect, or incomplete data affect the judgment of curative effect or safety.
- •Allergic constitution and allergic to the drug ingredients studied in this project.
- •Cicatricial constitution. 6.Occupational acne caused by chemicals, acne caused by drugs.
研究组 & 干预措施
TCM comprehensive treatment group
Participants in the TCM treatment group will receive BaiDi Quzhi granule two times daily after meals, Ju Yin cream therapy three times per week for 8 weeks.
干预措施: BaidI Quzhi granule (Drug)
TCM comprehensive treatment group
Participants in the TCM treatment group will receive BaiDi Quzhi granule two times daily after meals, Ju Yin cream therapy three times per week for 8 weeks.
干预措施: Ju Yin cream (Drug)
TCM internal treatment group
Participants in the TCM internal treatment group will receive Baidi Quzhi granule two times daily after meals and Ju Yin placebo therapy three times per week for 8 weeks.
干预措施: BaidI Quzhi granule (Drug)
TCM internal treatment group
Participants in the TCM internal treatment group will receive Baidi Quzhi granule two times daily after meals and Ju Yin placebo therapy three times per week for 8 weeks.
干预措施: Ju Yin placebo cream (Drug)
TCM external treatment group
Participants in the TCM external treatment group will receive Baidi Quzhi placebo granule two times daily after meals and Ju Yin cream therapy three times per week for 8 weeks.
干预措施: Ju Yin cream (Drug)
TCM external treatment group
Participants in the TCM external treatment group will receive Baidi Quzhi placebo granule two times daily after meals and Ju Yin cream therapy three times per week for 8 weeks.
干预措施: Baidi Quzhi placebo granule (Drug)
Placebo group
Participants in the placebo group will receive Baidi Quzhi placebo granule two times daily after meals, Ju Yin placebo therapy three times per week for 8 weeks.
干预措施: Baidi Quzhi placebo granule (Drug)
Placebo group
Participants in the placebo group will receive Baidi Quzhi placebo granule two times daily after meals, Ju Yin placebo therapy three times per week for 8 weeks.
干预措施: Ju Yin placebo cream (Drug)
结局指标
主要结局
Success rate of the investigators' overall assessment (IGA) for acne vulgaris
时间窗: up to 16th weeks
On the IGA (0-5) score, the percentage of subjects with IGA score reduction (baseline IGA- week 8 IGA) greater than or equal to 2 points.
次要结局
- skin lesion count (total, inflammatory and non-inflammatory)(Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).)
- Visual analogue scale (VAS) score of facial itching symptoms(Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).)
- Visual analogue scale(VAS) score of facial pain symptoms(Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).)
- Skindex-16 scale(Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).)
- Traditional Chinese Medicine(TCM) syndrome score(Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).)
- Interleukin(IL)-17(Patients will be evaluated at Baseline and at the 8th week.)
- 25-hydroxy Vitamin D(Patients will be evaluated at Baseline and at the 8th week.)
- Dehydroepiandrosterone-sulfate(DHEA-S)(Patients will be evaluated at Baseline and at the 8th week.)