Skip to content

A multicenter, randomized, open-label study to evaluate the efficacy and safety of Buxue Yimu Pills in the treatment of postpartum diseases

A multicenter, randomized, open-label study to evaluate the efficacy and safety of Buxue Yimu Pills in the treatment of postpartum diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109088
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-09-11
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Postpartum lochia that persists for more than three weeks and continues to flow in a prolonged or intermittent manner is termed as "prolonged lochia" (or "subinvolution of lochia" in medical terminology).

Interventions

Experimental group:Mothers in the experimental group will receive Bu Xue Yi Mu Wan (one sachet [12 g] per dose, twice daily for 14 consecutive days) in combination with standard care. Standard care in
provision of easily digestible and nutrient-rich postpartum diet
initiation of early infant suckling
and advice to maintain emotional well-being and adequate sleep.
Control group:Mothers in the control group will receive Xian Yi Mu Cao Capsules (3 capsules per dose, three times daily for 14 consecutive days) in combination with standard care. Standard care includ
provision of an easily digestible and nutrient-rich postpartum diet

Sponsors

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1.Age: 20-45 years old. 2.Singleton, full-term vaginal delivery (gestational age at delivery: 37-42 weeks). 3.Postpartum condition meets clinical diagnostic criteria for abdominal pain. 4.The puerperal woman is willing to engage in breastfeeding.

Exclusion criteria

Exclusion criteria: 1. Presence of severe pregnancy-related complications (e.g., autoimmune diseases during pregnancy requiring treatment with immunosuppressants, hormones, or anticoagulants; preeclampsia; gestational diabetes; intrahepatic cholestasis of pregnancy). 2. Neonatal macrosomia (birth weight > 4000 g), low birth weight (birth weight = 500 mL). 4. Severe pain caused by other factors (e.g., severe soft tissue trauma during delivery, such as third- or fourth-degree perineal lacerations or vaginal tears). 5. History of organic uterine lesions, genital tract malformations, pelvic tumors, pelvic organ prolapse (stage II or higher), or prior pelvic surgery. 6. Coexisting severe cardiovascular, cerebrovascular, hepatic, renal, coagulation, hematological, or gastrointestinal disorders. 7. Poor breast development, inverted or flat nipples, or history of breast surgery that may impair breastfeeding. 8. Maternal severe infectious diseases or other conditions that may affect breastfeeding (e.g., HIV, active tuberculosis). 9. Diagnosed with depression, anxiety, or other psychiatric disorders; history of mental illness or long-term use of psychotropic medications. 10. Use of other Chinese herbal medicines or proprietary formulations with uterotonic, analgesic, or blood-activating/stasis-resolving effects.

Design outcomes

Primary

MeasureTime frame
The duration of postpartum vaginal lochia discharge;

Secondary

MeasureTime frame
Lactation volume and the onset time of lactation;Uterine involution status;Abdominal pain Visual Analogue Scale (VAS) score;Serum Ferritin and Improvement in Anemia;Pelvic Floor Function Recovery;Changes in Clinical Symptom Scores;

Countries

China

Contacts

Public ContactZhang Hai

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

zhanghai@51mch.com+86 21 20261401

Outcome results

None listed

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