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NCT Number: NCT04528108

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

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.

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Key information

Conditions

Dysfunctional Uterine Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

10 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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.

Gong Xue Ning capsules

Drug

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.

Primary outcomes

  1. Restoration of menstruation cycle(binomial)

    Time frame: 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 outcomes

  1. Menstrual hemostatic time

    Time frame: 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.

  2. Menstrual blood volume

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2020
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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