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A clinical research of post-marketing drug Zengru orintment for promoting the secretion of breast milk

An open, blank controlled, stratified random, multi-centre clinical research about zengru orintment for promoting the secretion of breast milk

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007376
Enrollment
Unknown
Registered
2015-11-11
Start date
2013-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Lack of maternal milk secretion

Interventions

Treatment group:Zengru orintment, 30g/time, three times a day
Control group:Blank control

Sponsors

First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Puerpera who just gave birth to a baby but haven't been discharged from the hospital; 2. age from 20 to 35(not include 35); 3. gestational age from 37 weeks to 42 weeks(not include 42 weeks), give birth to the baby at the hospital, have no complications, the weight of new borned baby is greater than or equals 2500g, Apgar Score is greater than or equal 8, single birth, no diagnosing of Congenital disease or deformity; 4. agree to feed the baby by breast milk, volunteer to sign the informed consent form and agree to accomplish all the inspection, examine and intervention.

Exclusion criteria

Exclusion criteria: 1. No exhausting of air 72 hours after childbirth in puerpera underwent caesarean section; 2. puerpera who may cause new born ABO type hemolytic disease, Rh type hemolytic disease, thalassemia and favism; 3. allergic to the composition of the experimental medicine; 4. serious breast disease which causes the severe damage of brest tissue; 5. anatomical defeat and functional abnormal of the breast(such as crater nipple); 6. had augmentation mammoplasty before; 7. something that can influence the prolactin level, such as oral administration or injection of abundant estrogen, or have hyroid disease, parathyroid disease, pituitary adenoma or hyperprolactinemia; 8. patients have severe cardiovascular, liver, kidney, blood and immune system disease and patients with diabetes, mental disease, tuberculosis, or malignant tumor; 9. patient with postpartum bleeding(defined as more than 500ml of bleeding amount after childbirth); 10. patients take part in other clinical trials within 3 monthes.

Design outcomes

Primary

MeasureTime frame
Comprehensive efficacy assessment;

Secondary

MeasureTime frame
Additive amount of new born formula;Change of EPDS from baseline;Score of breast swelling degree;

Countries

China

Contacts

Public ContactLi Daocheng
daochenli@126.com+86 20-36598857

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026