Efficacy Evaluation of Kidney-tonifying and Tune up Chong-Ren Hemostasis Chinese Medicine Periodic Therapy for Dysfunctional Uterine Bleeding During Adolescence With Yin Deficiency and Blood Heat Syndrome: a Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Restoration of menstruation cycle(binomial)
研究概览
简要总结
The purpose of this study is to conduct a randomized, single blind, controlled intervention trial to observe the therapeutic effect of kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine periodic therapy for dysfunctional uterine bleeding based on objective Chinese and western medicine evaluation standard.
详细描述
Dysfunctional uterine bleeding during adolescence is the most common menstrual disorders during adolescence, and the age of children suffering from it tended to be lower. It's urgent to explore effective ways to alleviate the pain caused by dysfunctional uterine bleeding.
In our research, 160 children are randomly divided into a Chinese medication periodic therapy group (80 cases) and a Gong Xue Ning control group (80 cases). Paticipants in Chinese medication periodic therapy group are treated with kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine for 3 months, whereas the Gong Xue Ning control group received Gong Xue Ning capsules for 3 months. We compare the effect of the two therapies about hemostasis and menstruation regulation, and the change of the thickness of endometrium, sex hormones, Kisspeptin, and PAI-1 in blood before and after the treatment, in order to make clear the efficacy and the mechanism of the Chinese medicine periodic therapy.
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, Outcomes Assessor)
盲法说明
In our research, participants and outcome assessor are are prevented from having knowledge of the interventions assigned to individual participants.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •satisfy the diagnostic criteria in the textbook<Obstetrics and Gynecology> with dysfunctional uterine bleeding
- •age between 10-18 years
- •course of the disease is 2 months or more.
排除标准
- •have uterine bleeding on account of systemic diseases or organic diseases in reproductive system, such as blood diseases, thyroid diseases, hepatic diseases, etc.
- •HB<80g/L
- •have mental disorders
- •allergic to many kinds of drugs
研究组 & 干预措施
ZYZQ Group
ZYZQ group is the experimental group which is treated with kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine for 3 months.
干预措施: Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine (Drug)
GXN Group
GXN group is the active Comparator group which is treated with Gong Xue Ning capsules for 3 months
干预措施: Gong Xue Ning capsules (Drug)
结局指标
主要结局
Restoration of menstruation cycle(binomial)
时间窗: the end of the third months
Restoration of menstruation cycle is a binomial variable. Through clinical follow-up and menstrual diary, we record participants' menstrual period at month 3 of the treatment to confirm the restoration of menstruation, and we regard the menstrual cycle that is within 25-35 days as a normal cycle. Then normal cycles are defined as 1, and the rest are defined as 0.
次要结局
- Menstrual blood volume(during procedure (about 3 months))
- Menstrual hemostatic time(during procedure (about 3 months))