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

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

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.

Study Overview

• Status: Completed
• Conditions: Dysfunctional Uterine Bleeding
• Intervention / Treatment: Drug: Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine; Drug: Gong Xue Ning capsules

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Kidney-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.
Active Comparator: GXN Group; GXN group is the active Comparator group which is treated with Gong Xue Ning capsules for 3 months	Drug: Gong 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration of menstruation cycle(binomial)	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.	the end of the third months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual hemostatic time	We give every patient a menstrual diary to record the length of menstrual bleeding every month in order to confirm the hemostatic time.	during procedure (about 3 months)
Menstrual blood volume	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.	during procedure (about 3 months)

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: August 22, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Metrorrhagia; Uterine Hemorrhage; Yin Deficiency; Coagulants; Hemostatics
• Other Study ID Numbers: 19401931000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No