BleedingNCT06636422
Post-marketing Safety and Efficacy Surveillance of Motherwort Injection
An observational study of Bleeding and Real-world Study, run by Zhong Wang.
Trial summary
This study aims to provide evidence concerning the safety and efficacy of motherwort injection in real-world settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bleeding, Real-world Study, Adverse Events
- What is being tested?
- Motherwort injection
- Type of treatment
- Injection or infusion
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 15 Oct 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from designated medical institutions (departments) who meet the clinical indications for the use of motherwort injection as determined by a physician, voluntarily participate in this study, and fulfill ethical requirements.
Who may be able to join
- Meet the clinical indications for the use of motherwort injection
- Voluntarily participate in this study
- Fulfill ethical requirements.
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post-marketing Safety and Efficacy Surveillance of Motherwort Injection : a Registry Study
This study aims to provide evidence concerning the safety and efficacy of motherwort injection in real-world settings.
- Conditions
- Bleeding, Real-world Study, Adverse Events
- Being tested
- Motherwort injection
- Keywords
- Adverse events, Motherwort injection, bleeding, real-world study, Post-abortion hemorrhage, Uterine retraction
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motherwort injectionDrug
Also called Yimucao Injection
Patients will be given motherwort injection according to their disease condition in the real world. The investigator only can record the information on the usage of the drug and the relevant medications without any interventions.
| Study group | Role | What they receive |
|---|---|---|
| Patients indicated for Motherwort injection | During the registration and enrollment period of the study, all patients who meet the clinical indications for the use of motherwort injection, as determined by the physician, and voluntarily agree to participate while fulfilling ethical requirements, will be recruited from designated medical institutions and departments. The observation period for each observer was established based on the clinical application of motherwort injection. Receives: Drug: Motherwort injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The type and incidence of adverse events.
Measured: From the initiation of medication to 7 days after cessation.
Bleeding control.
Including:1. Hysteroscopic surgery: the intraoperative blood loss, the postoperative blood loss, the cumulative bleeding time.
2.Uterine fibroid resection: the intraoperative blood loss, the postoperative blood loss, the cumulative bleeding time.
Measured: From the commencement of the surgery to the end of bleeding event, assessed up to 1 year.
The incidence of postpartum hemorrhage.
Postpartum hemorrhage is defined as a blood loss of ≥500 ml following vaginal delivery or ≥1000 ml following cesarean delivery, or the presence of symptoms or signs of hypovolemia associated with blood loss within 24 hours .
Measured: From the completion of the surgery to 24 hours following the delivery of the fetus.
The post-abortion recovery.
The interval time to the resumption of menstruation post-surgery.
Measured: From the completion of the abortion to the subsequent onset of menstruation, assessed up to 1 year.
The incidence of post-abortion bleeding.
The cumulative days of postoperative bleeding.
Measured: From the completion of the abortion to the end of bleeding event.
Secondary outcomes (4)
The types and incidence of adverse reactions.
Measured: From the initiation of medication to 7 days after cessation.
Analysis of factors associated with adverse reactions.
Measured: From the initiation of medication to 7 days after cessation.
The menstrual adjustment.
Ovulatory dysfunction-related abnormal uterine bleeding: utilizing a treatment satisfaction assessment (0 = dissatisfied; 1 = neutral; 2 = somewhat satisfied; 3 = very satisfied).
Measured: From the initiation of medication to menstruation returns to normal or the treatment is completed, whichever came first, assessed up to 1 year.
The uterine retraction status.
Including:1.Rate of poor uterine involution: poor uterine involution is defined as the persistence of lochia beyond 42 days postpartum. 2. Duration of lochia cessation.
Measured: From the the postpartum to the end of bleeding event, assessed up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhong Wang, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636422
- Sponsor's protocol ID
- Motherwort-V2.0
- Status last verified
- Mar 2024
- First submitted
- 30 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Safety and Efficacy Surveillance of Motherwort Injection : a Registry Study
- ClinicalTrials.gov ID
- NCT06636422
- Acronym / sponsor ID
- Motherwort-V2.0
- Conditions
- Bleeding, Real-world Study, Adverse Events
- Keywords
- Adverse events, Motherwort injection, bleeding, real-world study, Post-abortion hemorrhage, Uterine retraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
This study aims to provide evidence concerning the safety and efficacy of motherwort injection in real-world settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients indicated for Motherwort injection | – | Drug: Motherwort injectionDuring the registration and enrollment period of the study, all patients who meet the clinical indications for the use of motherwort injection, as determined by the physician, and voluntarily agree to participate while fulfilling ethical requirements, will be recruited from designated medical institutions and departments. The observation period for each observer was established based on the clinical application of motherwort injection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from designated medical institutions (departments) who meet the clinical indications for the use of motherwort injection as determined by a physician, voluntarily participate in this study, and fulfill ethical requirements.
Key inclusion criteria (3 listed)
- Meet the clinical indications for the use of motherwort injection
- Voluntarily participate in this study
- Fulfill ethical requirements.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Motherwort injectionAlso: Yimucao InjectionPatients will be given motherwort injection according to their disease condition in the real world. The investigator only can record the information on the usage of the drug and the relevant medications without any interventions. | Drug | Patients indicated for Motherwort injection |
Primary outcome
The type and incidence of adverse events.
Time frame: From the initiation of medication to 7 days after cessation.
Bleeding control.
Time frame: From the commencement of the surgery to the end of bleeding event, assessed up to 1 year.
Including:1. Hysteroscopic surgery: the intraoperative blood loss, the postoperative blood loss, the cumulative bleeding time. 2.Uterine fibroid resection: the intraoperative blood loss, the postoperative blood loss, the cumulative bleeding time.
The incidence of postpartum hemorrhage.
Time frame: From the completion of the surgery to 24 hours following the delivery of the fetus.
Postpartum hemorrhage is defined as a blood loss of ≥500 ml following vaginal delivery or ≥1000 ml following cesarean delivery, or the presence of symptoms or signs of hypovolemia associated with blood loss within 24 hours .
The post-abortion recovery.
Time frame: From the completion of the abortion to the subsequent onset of menstruation, assessed up to 1 year.
The interval time to the resumption of menstruation post-surgery.
The incidence of post-abortion bleeding.
Time frame: From the completion of the abortion to the end of bleeding event.
The cumulative days of postoperative bleeding.
4 secondary outcomes
The types and incidence of adverse reactions.
Time frame: From the initiation of medication to 7 days after cessation.
Analysis of factors associated with adverse reactions.
Time frame: From the initiation of medication to 7 days after cessation.
The menstrual adjustment.
Time frame: From the initiation of medication to menstruation returns to normal or the treatment is completed, whichever came first, assessed up to 1 year.
The uterine retraction status.
Time frame: From the the postpartum to the end of bleeding event, assessed up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding and Real-world Study, run by Zhong Wang.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Wang (13601315446, zhonw@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The type and incidence of adverse events. (time frame: From the initiation of medication to 7 days after cessation.). The study lists 5 primary outcomes in all. 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 15 Oct 2024.