Postpartum AnemiaPhase 1/2NCT02656225
Effect of Ejiao Compound in the Treatment of Postpartum Anemia of Qi-blood Deficiency Syndrome
A Phase 1/2 study testing Ejiao compound and Niferex in people with Postpartum Anemia, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Anemia
- What is being tested?
- Ejiao compound and Niferex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Aug 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405
Yanfang Li, PhD, +86 13928777126, gzyanfangli@hotmail.com
About this study
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Postpartum Anemia
- Being tested
- Ejiao compound, Niferex
- Keywords
- postpartum anemia, hemoglobin, iron metabolism, Traditional Chinese Medicine, Ejiao
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ejiao compoundDrug
Also called Chinese patent medicine
20ml,twice daily, orally after breakfast Duration:4 weeks
NiferexDrug
Also called Polysaccharide Iron Complex
one tablet,once daily, orally after breakfast Duration:4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ejiao compound | Experimental | The participants in experimental group receive Ejiao compound (20ml, twice daily) orally for 4 weeks. Receives: 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. Receives: Drug: Niferex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin(Hb)
Measured: before and after treatment
Secondary outcomes (3)
Serum ferritin
Measured: before and after treatment
Life quality assessment: a Health Assessment Questionnaire(The Short Form-36 Health Survey, SF-36)
Measured: before and after treatment
Traditional Chinese Medicine symptom score:a self-made scale for Qi-blood Deficiency Syndrome
Measured: before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postpartum AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Investigators
- yanfang Li, PhD, Study chair, the First Affiliated Hospital, Guangzhou University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656225
- Sponsor's protocol ID
- PA-1
- Status last verified
- Mar 2016
- First submitted
- 31 Dec 2015
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 15495089Bhandal 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.
PubMed 17004982Ramakers 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.
PubMed 22548729Breymann 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.
PubMed 20577752Milman 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.
PubMed 21710167Milman 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.
PubMed 22160256Bergmann 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.
PubMed 20303210
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ejiao Compound in the Treatment of Postpartum Anemia of Qi-blood Deficiency Syndrome: Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02656225
- Acronym / sponsor ID
- PA-1
- Conditions
- Postpartum Anemia
- Keywords
- postpartum anemia, hemoglobin, iron metabolism, Traditional Chinese Medicine, Ejiao
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ejiao compound | Experimental | Drug: Ejiao compoundThe participants in experimental group receive Ejiao compound (20ml, twice daily) orally for 4 weeks. |
| Niferex | Active comparator | Drug: NiferexThe participants in control group receive Polysaccharide Iron Complex(Niferex)(150mg per tablet, once daily) orally after breakfast over 4 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ejiao compoundAlso: Chinese patent medicine20ml,twice daily, orally after breakfast Duration:4 weeks | Drug | Ejiao compound |
| NiferexAlso: Polysaccharide Iron Complexone tablet,once daily, orally after breakfast Duration:4 weeks | Drug | Niferex |
Primary outcome
Hemoglobin(Hb)
Time frame: before and after treatment
3 secondary outcomes
Serum ferritin
Time frame: before and after treatment
Life quality assessment: a Health Assessment Questionnaire(The Short Form-36 Health Survey, SF-36)
Time frame: before and after treatment
Traditional Chinese Medicine symptom score:a self-made scale for Qi-blood Deficiency Syndrome
Time frame: before and after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Background: PubMed 15495089Dodd 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.
- Background: PubMed 17004982Bhandal 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.
- Background: PubMed 22548729Ramakers 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.
- Background: PubMed 20577752Breymann 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.
- Background: PubMed 21710167Milman 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.
- Background: PubMed 22160256Milman 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.
- Background: PubMed 20303210Bergmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yanfang Li, PhD study chair
the First Affiliated Hospital, Guangzhou University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ejiao compound and Niferex in people with Postpartum Anemia, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanfang Li, PhD (+86 13928777126, gzyanfangli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin(Hb) (time frame: before and after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656225, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.