Chinese Medicine Periodic Therapy for Dysfunctional Uterine Bleeding During Adolescence With Yin Deficiency and Blood Heat Syndrome
- Conditions
- Dysfunctional Uterine Bleeding
- Interventions
- Drug: Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicineDrug: Gong Xue Ning capsules
- Registration Number
- NCT04528108
- Lead Sponsor
- Children's Hospital of Fudan University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZYZQ Group Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine ZYZQ group is the experimental group which is treated with kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine for 3 months. GXN Group Gong Xue Ning capsules GXN group is the active Comparator group which is treated with Gong Xue Ning capsules for 3 months
- Primary Outcome Measures
Name Time Method Restoration of menstruation cycle(binomial) 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.
- Secondary Outcome Measures
Name Time Method Menstrual blood volume during procedure (about 3 months) Menstrual blood volume is a repeated measurement variable. We give every participant a pictorial blood loss assessment chart (PBAC) to measure the menstrual blood volume. They fill in the chart every day during menstrual period according to the degree to which each item of sanitary protection was soiled with blood, thus we can calculate a score and speculate the menstrual blood volume based on that.
Menstrual hemostatic time during procedure (about 3 months) We give every patient a menstrual diary to record the length of menstrual bleeding every month in order to confirm the hemostatic time.
Trial Locations
- Locations (1)
Children's Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China