Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Ejiao Compound in the Treatment of Postpartum Anemia of Qi-blood Deficiency Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02656225
Recruitment Status : Unknown
Verified March 2016 by Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : January 14, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

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.


Condition or disease Intervention/treatment Phase
Postpartum Anemia Drug: Ejiao compound Drug: Niferex Phase 1 Phase 2

Detailed Description:
  1. Study type: This is a randomized, parallel controlled and single blind study. The sample ratio of the experimental group and the control group will be 1:1.
  2. Study Setting and Recruitment: All participants experience vaginal delivery and are diagnosed with mild postpartum anemia. They will be recruited from the obstetric inpatient department in two hospitals: the first affiliated hospital of Guangzhou University of Traditional Chinese Medicine, and Maternal and Child Health Hospital of Panyu District in Guangzhou City. All assessments and interventions will occur at hospitals.
  3. Randomization, blinded method, and allocation concealment: Patients meeting the criteria were randomized into experimental group or control group, according to a computer-generated list. The patients in experimental group will receive the treatment of Ejiao compound while the patients in control group will be treated by Polysaccharide iron complex. The study physicians will receive a sealed decoding envelope per treatment, they will not know the identity of the participants, will not handle the study products, will not know the assigned treatment, and will not share their own examination results. After receiving the evaluation by the study physicians and finishing the investigation form, the patient will take her own sealed decoding envelope and go to the pharmacy of the clinical trial center to receive her medication. The staff of the pharmacy of the clinical trial center is responsible for the distribution and return of experimental drugs to patients. All envelopes, sealed or unsealed, will be returned to the investigators at the end of the study. Patients would be required to return boxes whether they are used and unused at each visit and compliance will be assessed by counting the bottles and capsules.
  4. Sample size calculation: It was reported that treatment with oral iron for anemia in postpartum women increase the Hb concentration by 49.3% by day 40. Combined with etiological treatment, Ejiao compound used to treat anemia in non pregnant population for three months, the Hb concentration increased by 66.9%. Basing on the results of literatures mentioned above, the investigators suppose that the difference of Hb concentration between patients only receiving the Ejiao compound for 4 weeks and patients only receiving oral iron for 4 weeks would be 25.0%. The α-value is set at 0.05 and the test power is 0.90. The final sample size should be 68 in each group. With an anticipated dropout rate of 20% during the follow-up, the initial sample size for each group should be 85, and 170 in total for two groups.
  5. Statistical analysis: The statisticians will be blinded to the allocation of the participants. Statistics Package for Social Science (SPSS)19.0 statistical software packages will be used to analyze the data. The intention-to-treat population will include all randomized patients who receive the assigned treatment at least once, and who have an evaluation of outcomes. The measurement data will be analyzed by using t-test or the rank sum test, and the numeration data will be analyzed by using chi-square test or Fisher's exact test. P<0.05 indicates statistical significance.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Ejiao Compound in the Treatment of Postpartum Anemia of Qi-blood Deficiency Syndrome: Study Protocol of a Randomized Controlled Trial
Study Start Date : March 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Niferex

Arm Intervention/treatment
Experimental: Ejiao compound
The participants in experimental group receive Ejiao compound (20ml, twice daily) orally for 4 weeks.
Drug: Ejiao compound
20ml,twice daily, orally after breakfast Duration:4 weeks
Other Name: Chinese patent medicine

Active Comparator: Niferex
The participants in control group receive Polysaccharide Iron Complex(Niferex)(150mg per tablet, once daily) orally after breakfast over 4 weeks.
Drug: Niferex
one tablet,once daily, orally after breakfast Duration:4 weeks
Other Name: Polysaccharide Iron Complex




Primary Outcome Measures :
  1. Hemoglobin(Hb) [ Time Frame: before and after treatment ]

Secondary Outcome Measures :
  1. Serum ferritin [ Time Frame: before and after treatment ]
  2. Life quality assessment: a Health Assessment Questionnaire(The Short Form-36 Health Survey, SF-36) [ Time Frame: before and after treatment ]
  3. Traditional Chinese Medicine symptom score:a self-made scale for Qi-blood Deficiency Syndrome [ Time Frame: before and after treatment ]

Other Outcome Measures:
  1. Adverse reactions or events: renal function [ Time Frame: before and after treatment ]
    serum creatinine and urea nitrogen

  2. Adverse reactions or events: liver function [ Time Frame: before and after treatment ]
    aspartate aminotransferase(AST), alanine aminotransferase (ALT)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656225


Contacts
Layout table for location contacts
Contact: Yanfang Li, PhD +86 13928777126 gzyanfangli@hotmail.com

Locations
Layout table for location information
China, Guangdong
the First Affiliated Hospital, Guangzhou University of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510405
Contact: Yanfang Li, PhD    +86 13928777126    gzyanfangli@hotmail.com   
Sponsors and Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Investigators
Layout table for investigator information
Study Chair: yanfang Li, PhD the First Affiliated Hospital, Guangzhou University of Chinese Medicine

Publications:
Layout table for additonal information
Responsible Party: Yanfang Li, Associate chief physician, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02656225     History of Changes
Other Study ID Numbers: PA-1
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine:
postpartum anemia
hemoglobin
iron metabolism
Traditional Chinese Medicine
Ejiao

Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Hematologic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs