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New Indication Evaluation of Hospital-based Kunbao Zhixue Granules: A Multicenter RCT

Kunbao Zhixue Granules for Postoperative Hemorrhage in Women After Surgical Abortion: A Randomized Double-Blind Multicenter Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001719
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-16
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Hemorrhage After Surgical Abortion

Interventions

control group:Oral Wujia Shenghua Capsules + Kunbao Hemostasis Granules Placebo Administration
test group:Hemostasis Granules + Wujia Shenghua Capsule Placebo Administration

Sponsors

Xiyuan Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age: 20 years old = Age = 40 years old. Gestation: Intrauterine pregnancy = 10 weeks gestation (Note: Preoperative ultrasound showing gestational sac mean diameter < 4 cm AND embryo length < 3 cm ), requesting termination of pregnancy without contraindications to vacuum aspiration. Syndrome Diagnosis: Meets the diagnostic criteria for Qi Deficiency and Blood Stasis Syndrome as defined in the National Standard for Clinical Diagnosis and Treatment Terminology in Traditional Chinese Medicine (Syndrome Part) 2021. Informed Consent: The subject voluntarily provides written informed consent.

Exclusion criteria

Exclusion criteria: Recent Abortion History: History of induced abortion within the past 6 months prior to the current procedure. Drug Hypersensitivity: Known hypersensitivity or allergy to the investigational drug(s). Uterine Abnormalities: Uterine malformations or large uterine fibroids (Note: Clinically symptomatic). Coagulation Disorders: Abnormal coagulation function, or current use of anticoagulant or hemostatic medications. Moderate/Severe Anemia: Moderate or severe anemia, defined as hemoglobin level < 90 g/L. Missed Abortion: Diagnosis of missed abortion. Unexplained Irregular Bleeding: History of unexplained irregular vaginal bleeding. Chronic Antithrombotic Use: Long-term use of anticoagulant or antiplatelet medications. Investigator Discretion: Any other condition deemed by the investigator as making the subject unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
Amount of Vaginal Bleeding After Induced Abortion;Time of Postoperative Bleeding;

Secondary

MeasureTime frame
Menstrual Symptom Rating Scale;Endometrial Thickness;Time to Menstrual Resumption;Self-Rating Anxiety Scale (SAS) Score;Pittsburgh Sleep Quality Index (PSQI) Score;Self-Rating Depression Scale (SDS) Score;TCM Syndrome Score;Amount of Vaginal Bleeding After Induced Abortion;

Countries

China

Contacts

Public ContactYang Qi

Xiyuan Hospital, China Academy of Chinese Medical Sciences

yangcewen@126.com15010388500

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026