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

NCT04528108 | Completed Phase 2

• 1 other identifier: 19401931000
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysfunctional Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Menstrual hemostatic time

  during procedure (about 3 months)

• Menstrual blood volume

  during procedure (about 3 months)

Study Arms (2)

ZYZQ Group

EXPERIMENTAL

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

GXN Group

ACTIVE COMPARATOR

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

Drug: Gong Xue Ning capsules

Interventions

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.

ZYZQ Group

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.

GXN Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Gender Eligibility Details: This condition of the study is dysfunctional uterine bleeding, so we can only include female participants in our study.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In our research, participants and outcome assessor are are prevented from having knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 27, 2020
• Study Start: September 2, 2020
• Primary Completion: June 30, 2022
• Study Completion: July 1, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)