The Comparison of the Effect on Danshen-Jiang-Fu Granule Prepared by Danshen (Salvia Miltiorrhiza) From Different Producing Areas (Shandong and Sichuan) for Primary Dysmenorrhea: a Cross-over, Randomized, Double-blind Controlled Trials
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale on the pain of dysmenorrhea
研究概览
简要总结
This trial aims to compare the effect of Danshen-Jiang-Fu Granule prepared by Danshen (Salvia Miltiorrhiza) from different producing areas (Shandong and Sichuan) for the relief of primary dysmenorrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •meeting the diagnostic criteria of primary dysmenorrhea in the Primary Dysmenorrhea Consensus Guideline;
- •meeting the diagnostic criteria of Hanning-xueyu(blood stasis due to cold accumulation) Zheng according to Gynecology of Chinese medicine;
- •with regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 9 days in the last 6 months;
- •course of dysmenorrhea over 6 months;
- •experienced menstrual pain scoring varying from 3cm to 6cm on a 10-cm VAS during the baseline menstrual period (one period prior to present menstrual period with treatment);
- •without history of pregnancy;
- •with agreement of informed consent and a working phone.
排除标准
- •history of abdominal surgery;
- •with other acute or chronic painful conditions diagnosed or suspected;
- •use of hormonal contraceptives, or intra-uterine device;
- •use of analgetic drugs or other analgetic treatment in the last 2 weeks;
- •known allergy to Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi) or Wuyao(Lindera Aggregata);
- •prone to allergy in daily life;
- •who can not complete treatment adherence to the protocol;
- •attending in other trials in the last 3 months.
研究组 & 干预措施
Experimental
The patients in this arm will be given 1 bag per time of Shandong Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the first menorrhea period. And then in the next menstrual cycle, the patients will in turn be given 1 bag per time of Sichuan Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the second menorrhea period.
干预措施: Shandong Danshen-Jiang-Fu Granule (Drug)
Experimental
The patients in this arm will be given 1 bag per time of Shandong Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the first menorrhea period. And then in the next menstrual cycle, the patients will in turn be given 1 bag per time of Sichuan Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the second menorrhea period.
干预措施: Sichuan Danshen-Jiang-Fu Granule (Drug)
controlled
The patients in this arm will be given 1 bag per time of Sichuan Danshen-Jiang-Fu Granule prepared, twice a day for 5 days before menorrhea and the first 2 days in the first menorrhea period. And then in the next menstrual cycle, the patients will in turn be given 1 bag per time of Shandong Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the second menorrhea period.
干预措施: Shandong Danshen-Jiang-Fu Granule (Drug)
controlled
The patients in this arm will be given 1 bag per time of Sichuan Danshen-Jiang-Fu Granule prepared, twice a day for 5 days before menorrhea and the first 2 days in the first menorrhea period. And then in the next menstrual cycle, the patients will in turn be given 1 bag per time of Shandong Danshen-Jiang-Fu Granule, twice a day for 5 days before menorrhea and the first 2 days in the second menorrhea period.
干预措施: Sichuan Danshen-Jiang-Fu Granule (Drug)
结局指标
主要结局
Visual Analogue Scale on the pain of dysmenorrhea
时间窗: 2 months
次要结局
- Cox Menstrual Symptom Scale(2 months)
- Daily Symptom Scale(2 months)
- The change on the index of uterine artery doppler ultrasound(2 months)
研究者
Zhong Wang
Chief
China Academy of Chinese Medical Sciences