Postpartum AnemiaPhase 4NCT06175117
Clinical Study on the Treatment of Postpartum Anemia With Compound E Jiao Jiang(cEJJ）
A Phase 4 study testing compound E Jiao Jiang(cEJJ) in people with Postpartum Anemia, run by DongE E Jiao Coporation Limited at 1 site in China.
Trial summary
The goal of this clinical trial] is to compare the effect of compound E Jiao Jiang(cEJJ）combined with iron decoction on postpartum anemia.The main questions it aims to answer are: To evaluate the effectiveness of compound E Jiao Jiang(cEJJ） in the treatment of postpartum anemia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Anemia
- What is being tested?
- compound E Jiao Jiang(cEJJ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2023to 8 Sep 2025
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with mild or moderate anemia (70g/L≤Hb < 110g/L) within 1 week postpartum and suitable for oral drug therapy;
- Age 18-45 years old (including 18 and 45);
- Those who do not use other iron agents and Chinese medicine/Chinese medicine preparations that have the effect of invigorating qi and nourishing blood during the study;
- Sign the subject's informed consent voluntarily.
Who cannot join
- Postpartum hemorrhage and blood transfusion treatment;
- Those who received intramuscular/intravenous iron therapy or transfused blood products/human blood albumin and other plasma volume dilators within 3 months prior to screening;
- Patients who have taken blood tonics within 1 week before screening, including other iron preparations and Chinese medicine or Chinese medicine preparations;
- People with previous blood diseases such as sickle cell anemia, thalassemia, aplastic anemia, megaloblastic anemia;
- Severe preeclampsia during pregnancy;
- Abortion occurs in this pregnancy;
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- Patients with a serious digestive disease, cardiovascular disease, immune system disease, or serious mental disorder that the investigator believes may adversely affect the safety of the subject and/or the effectiveness of the investigational drug;
- Severe hepatic and renal insufficiency (ALT >2×ULN, aspartate aminotransferase (AST)>2×ULN, Urea (Urea)/ urea nitrogen (BUN)>2×ULN, creatinine (Cr)>1×ULN);
- Those who have a history of alcohol abuse, drug abuse or drug use before;
- Allergic to the experimental drug or known ingredient;
- Participants who had participated in other clinical trials within 3 months before screening;
- Those who, according to the judgment of the investigator, consider it inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Obstetrics and Gynecology Hospital,Capital Medical UniversityBeijing Maternal and Child Health Care Hospital
Beijing
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Compound E Jiao Jiang(cEJJ）in the Treatment of Postpartum Anemia
The goal of this clinical trial] is to compare the effect of compound E Jiao Jiang(cEJJ）combined with iron decoction on postpartum anemia.The main questions it aims to answer are:
To evaluate the effectiveness of compound E Jiao Jiang(cEJJ） in the treatment of postpartum anemia.
Read more
To evaluate the safety of compound E Jiao Jiang(cEJJ） in the treatment of postpartum anemia.
To explore the effect of compound ejiao decoction on improving anxiety, depression, sleep and fatigue in postpartum anemia patients.
Participants will be randomly assigned (like flipping a coin) to either the trial group or the control group (with a 50% chance of being assigned to either group), where the trial group will receive the compound E Jiao Jiang(cEJJ） + ferrous succinate tablet, and the control group will receive the compound E Jiao Jiang(cEJJ）placebo + ferrous succinate tablet. The compound E Jiao Jiang(cEJJ）placebo is the same/similar to the compound E Jiao Jiang(cEJJ） in terms of appearance, smell and taste, but has no therapeutic effect.And participants need to return to the research center on time for relevant examinations according to the protocol requirements.
- Conditions
- Postpartum Anemia
- Being tested
- compound E Jiao Jiang(cEJJ), compound E Jiao Jiang(cEJJ) placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compound E Jiao Jiang(cEJJ)Drug
Also called ferrous succinate tablet（1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.）
compound E Jiao Jiang(cEJJ)：20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.
compound E Jiao Jiang(cEJJ) placeboDrug
Also called ferrous succinate tablet（1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.）
compound E Jiao Jiang(cEJJ) placebo：20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.
| Study group | Role | What they receive |
|---|---|---|
| compound E Jiao Jiang(cEJJ) | Experimental | 20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. Receives: Drug: compound E Jiao Jiang(cEJJ) |
| compound E Jiao Jiang(cEJJ) placebo | Placebo comparator | 20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. Receives: Drug: compound E Jiao Jiang(cEJJ) placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin（Hb） change value
Hb changes after 6 weeks of continuous medication
Measured: 6 weeks
Secondary outcomes (8)
The proportion of hemoglobin returned to normal
Hb returned to normal proportions after 6 weeks of continuous medication
Measured: 6 weeks
The proportion of hemoglobin rising > 20g/L
The proportion of Hb increased >20g/L after 6 weeks of continuous administration
Measured: 6 weeks
The proportion of hemoglobin rising > 10g/L
The proportion of Hb increased >10g/L after 6 weeks of continuous administration
Measured: 6 weeks
serum iron change value
serum iron changes after 6 weeks of continuous medication
Measured: 6 weeks
serum ferritin change value
serum ferritin changes after 6 weeks of continuous medication
Measured: 6 weeks
Red Blood Cell（RBC） change value
RBC changes after 6 weeks of continuous medication
Measured: 6 weeks
Hematocrit（HCT ）change value
HCT changes after 6 weeks of continuous medication
Measured: 6 weeks
Traditional Chinese Medicine symptom score（a self-made scale for Qi-blood Deficiency Syndrome） change value
The TCM Qi and blood deficiency scale total score ranges from 0 to 54, and the higher the score, the more serious it is.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start7 Jan 2023
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongE E Jiao Coporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175117
- Sponsor's protocol ID
- DEEJ-CTP-20230724
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Compound E Jiao Jiang(cEJJ）in the Treatment of Postpartum Anemia
- ClinicalTrials.gov ID
- NCT06175117
- Acronym / sponsor ID
- DEEJ-CTP-20230724
- Conditions
- Postpartum Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- DongE E Jiao Coporation LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 18 Dec 2023 (actual)
- 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 goal of this clinical trial] is to compare the effect of compound E Jiao Jiang(cEJJ）combined with iron decoction on postpartum anemia.The main questions it aims to answer are:
To evaluate the effectiveness of compound E Jiao Jiang(cEJJ） in the treatment of postpartum anemia.
To evaluate the safety of compound E Jiao Jiang(cEJJ） in the treatment of postpartum anemia.
To explore the effect of compound ejiao decoction on improving anxiety, depression, sleep and fatigue in postpartum anemia patients.
Participants will be randomly assigned (like flipping a coin) to either the trial group or the control group (with a 50% chance of being assigned to either group), where the trial group will receive the compound E Jiao Jiang(cEJJ） + ferrous succinate tablet, and the control group will receive the compound E Jiao Jiang(cEJJ）placebo + ferrous succinate tablet. The compound E Jiao Jiang(cEJJ）placebo is the same/similar to the compound E Jiao Jiang(cEJJ） in terms of appearance, smell and taste, but has no therapeutic effect.And participants need to return to the research center on time for relevant examinations according to the protocol requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compound E Jiao Jiang(cEJJ) | Experimental | Drug: compound E Jiao Jiang(cEJJ)20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. |
| compound E Jiao Jiang(cEJJ) placebo | Placebo comparator | Drug: compound E Jiao Jiang(cEJJ) placebo20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with mild or moderate anemia (70g/L≤Hb < 110g/L) within 1 week postpartum and suitable for oral drug therapy;
- Age 18-45 years old (including 18 and 45);
- Those who do not use other iron agents and Chinese medicine/Chinese medicine preparations that have the effect of invigorating qi and nourishing blood during the study;
- Sign the subject's informed consent voluntarily.
Key exclusion criteria (12 listed)
- Postpartum hemorrhage and blood transfusion treatment;
- Those who received intramuscular/intravenous iron therapy or transfused blood products/human blood albumin and other plasma volume dilators within 3 months prior to screening;
- Patients who have taken blood tonics within 1 week before screening, including other iron preparations and Chinese medicine or Chinese medicine preparations;
- People with previous blood diseases such as sickle cell anemia, thalassemia, aplastic anemia, megaloblastic anemia;
- Severe preeclampsia during pregnancy;
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 |
|---|---|---|
| compound E Jiao Jiang(cEJJ)Also: ferrous succinate tablet（1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.）compound E Jiao Jiang(cEJJ)：20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. | Drug | compound E Jiao Jiang(cEJJ) |
| compound E Jiao Jiang(cEJJ) placeboAlso: ferrous succinate tablet（1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.）compound E Jiao Jiang(cEJJ) placebo：20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. | Drug | compound E Jiao Jiang(cEJJ) placebo |
Primary outcome
Hemoglobin（Hb） change value
Time frame: 6 weeks
Hb changes after 6 weeks of continuous medication
8 secondary outcomes
The proportion of hemoglobin returned to normal
Time frame: 6 weeks
The proportion of hemoglobin rising > 20g/L
Time frame: 6 weeks
The proportion of hemoglobin rising > 10g/L
Time frame: 6 weeks
serum iron change value
Time frame: 6 weeks
serum ferritin change value
Time frame: 6 weeks
Red Blood Cell（RBC） change value
Time frame: 6 weeks
Hematocrit（HCT ）change value
Time frame: 6 weeks
Traditional Chinese Medicine symptom score（a self-made scale for Qi-blood Deficiency Syndrome） change value
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing compound E Jiao Jiang(cEJJ) in people with Postpartum Anemia, run by DongE E Jiao Coporation Limited 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 15 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin（Hb） change value (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.