Dysfunctional Uterine BleedingPhase 2NCT04528108
Chinese Medicine Periodic Therapy for Dysfunctional Uterine Bleeding During Adolescence With Yin Deficiency and Blood Heat Syndrome
A Phase 2 study testing Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine and Gong Xue Ning capsules in people with Dysfunctional Uterine Bleeding, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years, women only
- Conditions the study is for
- Dysfunctional Uterine Bleeding
- What is being tested?
- Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine and Gong Xue Ning capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2020to 1 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
About this study
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
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.
Read the 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.
- Conditions
- Dysfunctional Uterine Bleeding
- Being tested
- Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine, Gong Xue Ning capsules
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicineDrug
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 capsulesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Gong Xue Ning capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the end of the third months
Secondary outcomes (2)
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.
Measured: 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.
Measured: during procedure (about 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start2 Sep 2020
- Primary completion30 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528108
- Sponsor's protocol ID
- 19401931000
- Status last verified
- Apr 2022
- First submitted
- 22 Aug 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04528108
- Acronym / sponsor ID
- 19401931000
- Conditions
- Dysfunctional Uterine Bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ZYZQ Group | Experimental | Drug: Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicineZYZQ group is the experimental group which is treated with kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine for 3 months. |
| GXN Group | Active comparator | Drug: Gong Xue Ning capsulesGXN group is the active Comparator group which is treated with Gong Xue Ning capsules for 3 months |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicineParticipants 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. | Drug | ZYZQ Group |
| Gong Xue Ning capsulesParticipants 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. | Drug | GXN Group |
Primary outcome
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.
2 secondary outcomes
Menstrual hemostatic time
Time frame: during procedure (about 3 months)
Menstrual blood volume
Time frame: during procedure (about 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine and Gong Xue Ning capsules in people with Dysfunctional Uterine Bleeding, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of menstruation cycle(binomial) (time frame: the end of the third months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.