Clinical trial NCT04528108: Chinese Medicine Periodic Therapy for Dysfunctional Uterine Bleeding During Adolescence With Yin Deficiency and Blood Heat Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysfunctional Uterine Bleeding
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 160
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Restoration of menstruation cycle(binomial)
timeFrame: the end of the third months
Secondary outcomes:
measure: Menstrual hemostatic time
timeFrame: during procedure (about 3 months)
measure: Menstrual blood volume
timeFrame: during procedure (about 3 months)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References: