Dysfunctional Uterine Bleeding
Conditions
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.
Interventions
DRUGKidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine
Participants of Chinese medicine periodic therapy group will be treated with kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine periodic therapy. During bleeding period, use kidney-tonifying, heat-clearing and consolidating channel for hemostasis Chinese medicine to stop bleeding. The kidney-tonifying hemostasis prescription is made up of Nvzhenzi, Hanliancao, Tusizi, Xianhecao, Cebaiyetan, Danpi, Zhimu, etc. When the bleeding stops, use the kidney-tonifying, essence-strengthening and blood-activating, menstruation-regulating Chinese medicine to regulate menstruation. The kidney-tonifying and menstruation-regulating prescription is made up of Shengshudi, Zhimu, Tusizi, Fupenzi, Bajirou, Danggui, Danpi, etc. The drugs are granules for taking after infusion once a day. Participants receive this treatment for 3 months.
DRUGGong Xue Ning capsules
Participants of Gong Xue Ning capsules group children will be treated with Gong Xue Ning capsules, 2 capsules 3 times a day during the bleeding period. When the bleeding stops, patients will be treated with Zhi Bai Dihuang pills,8 pills 3 times a day. Participants receive this treatment for 3 months.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In our research, participants and outcome assessor are are prevented from having knowledge of the interventions assigned to individual participants.
Intervention model description
In our research, 160 children are randomly divided into a Chinese medication periodic therapy group and a Gong Xue Ning control group, and they receive different treatment for 3 month.
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Outcome results
None listed