NCT02656225

Brief Summary

The prevalence of postpartum anemia is a great threat for maternal and infant health without timely and effective treatment. Oral iron therapy has been used for centuries as a treatment of anemia, however, it is noteworthy that treatment with oral iron might have a limited, and even a harmful role in some clinical scenarios. Ejiao compound is composed with donkey-hide glue, Ginseng, Codonopsis pilosula, prepared rhizome of rehmannia, and crab apple, which has been widely used in the treatment of various types of anemia in China for decades and might be a potentially effective therapy for postpartum anemia. Recently, studies involving animal subjects have helped shed light on its mechanism of action. In this study, the investigators aimed to conduct a randomized controlled trial to assess the efficacy and safety of Ejiao compound comparing with oral iron in the treatment of mild postpartum anemia with or without iron deficiency.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

December 31, 2015

Last Update Submit

March 25, 2016

Conditions

Postpartum Anemia

Keywords

postpartum anemiahemoglobiniron metabolismTraditional Chinese MedicineEjiao

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin(Hb)

    before and after treatment

Secondary Outcomes (3)

  • Serum ferritin

    before and after treatment

  • Life quality assessment: a Health Assessment Questionnaire(The Short Form-36 Health Survey, SF-36)

    before and after treatment

  • Traditional Chinese Medicine symptom score:a self-made scale for Qi-blood Deficiency Syndrome

    before and after treatment

Other Outcomes (2)

  • Adverse reactions or events: renal function

    before and after treatment

  • Adverse reactions or events: liver function

    before and after treatment

Study Arms (2)

Ejiao compound

EXPERIMENTAL

The participants in experimental group receive Ejiao compound (20ml, twice daily) orally for 4 weeks.

Drug: Ejiao compound

Niferex

ACTIVE COMPARATOR

The participants in control group receive Polysaccharide Iron Complex(Niferex)(150mg per tablet, once daily) orally after breakfast over 4 weeks.

Drug: Niferex

Interventions

Ejiao compoundDRUG

20ml,twice daily, orally after breakfast Duration:4 weeks

Also known as: Chinese patent medicine
Ejiao compound
NiferexDRUG

one tablet,once daily, orally after breakfast Duration:4 weeks

Also known as: Polysaccharide Iron Complex
Niferex

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18 years to 45 years with mild postpartum anemia (Hb \<10 g/dl and ≥7 g/dl at 24-48 hours postpartum);
  • Absence of antepartum anemia, which is defined as Hb≥11.0 g/dL within 48 hours before delivery;
  • Singleton pregnancy;
  • Type of syndrome in Traditional Chinese Medicine is "Qi-blood deficiency".
  • Patients having not received blood transfusion or any forms of anti-anemia treatment in Western medicine or TCM in the last 12 weeks;
  • Informed consent obtained.

You may not qualify if:

  • Type of syndrome in TCM is NOT "Qi-blood deficiency";
  • Antepartum anemia;
  • Twin or multiple pregnancies;
  • A history of haematological disease (e.g. sickle cell anemia or thalassemias);
  • A history of undigestive disease (e.g. gastric ulcer, gastritis) or inflammatory bowel disease;
  • A history of cardiovascular diseases, renal or liver disease, asthma, thromboembolism, HIV infection, tuberculosis, cancer and seizures;
  • Patients having received blood transfusion or any forms of anti-anemia treatment in Western medicine or TCM in the last 12 weeks;
  • Alcohol or drug abuse;
  • Patients with mental illness or poor compliance to medical treatment;
  • Participation in another clinical trial within the previous three months;
  • No informed consent obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital, Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510405, China

RECRUITING

Related Publications (7)

  • Dodd J, Dare MR, Middleton P. Treatment for women with postpartum iron deficiency anaemia. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004222. doi: 10.1002/14651858.CD004222.pub2.

    PMID: 15495089BACKGROUND

  • Bhandal N, Russell R. Intravenous versus oral iron therapy for postpartum anaemia. BJOG. 2006 Nov;113(11):1248-52. doi: 10.1111/j.1471-0528.2006.01062.x. Epub 2006 Sep 27.

    PMID: 17004982BACKGROUND

  • Ramakers C, van der Woude DA, Verzijl JM, Pijnenborg JM, van Wijk EM. An added value for the hemoglobin content in reticulocytes (CHr) and the mean corpuscular volume (MCV) in the diagnosis of iron deficiency in postpartum anemic women. Int J Lab Hematol. 2012 Oct;34(5):510-6. doi: 10.1111/j.1751-553X.2012.01423.x. Epub 2012 May 1.

    PMID: 22548729BACKGROUND

  • Breymann C, Honegger C, Holzgreve W, Surbek D. Diagnosis and treatment of iron-deficiency anaemia during pregnancy and postpartum. Arch Gynecol Obstet. 2010 Nov;282(5):577-80. doi: 10.1007/s00404-010-1532-z. Epub 2010 Jun 25.

    PMID: 20577752BACKGROUND

  • Milman N. Postpartum anemia I: definition, prevalence, causes, and consequences. Ann Hematol. 2011 Nov;90(11):1247-53. doi: 10.1007/s00277-011-1279-z. Epub 2011 Jun 28.

    PMID: 21710167BACKGROUND

  • Milman N. Postpartum anemia II: prevention and treatment. Ann Hematol. 2012 Feb;91(2):143-54. doi: 10.1007/s00277-011-1381-2. Epub 2011 Dec 9.

    PMID: 22160256BACKGROUND

  • Bergmann RL, Richter R, Bergmann KE, Dudenhausen JW. Prevalence and risk factors for early postpartum anemia. Eur J Obstet Gynecol Reprod Biol. 2010 Jun;150(2):126-31. doi: 10.1016/j.ejogrb.2010.02.030. Epub 2010 Mar 29.

    PMID: 20303210BACKGROUND

MeSH Terms

Interventions

Niferex

Study Officials

  • yanfang Li, PhD

    the First Affiliated Hospital, Guangzhou University of Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Yanfang Li, PhD

CONTACT

+86 13928777126gzyanfangli@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

December 31, 2015

First Posted

January 14, 2016

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

March 29, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)