Chinese Medicine Periodic Therapy for Dysfunctional Uterine Bleeding During Adolescence With Yin Deficiency and Blood Heat Syndrome

Fudan University

Status and phase: Completed; Phase 2

Conditions: Dysfunctional Uterine Bleeding

Treatments: Drug: Gong Xue Ning capsules; Drug: Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04528108

19401931000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

ZYZQ Group

Experimental group

Description:

ZYZQ group is the experimental group which is treated with kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine for 3 months.

Treatment:

Drug: Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine

GXN Group

Active Comparator group

Description:

GXN group is the active Comparator group which is treated with Gong Xue Ning capsules for 3 months

Treatment:

Drug: Gong Xue Ning capsules