Postpartum Anemia Clinical Trial
Official title:
Effect of Ejiao Compound in the Treatment of Postpartum Anemia of Qi-blood Deficiency Syndrome: Study Protocol of a Randomized Controlled Trial
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.
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.
;
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