Clinical Study on the Treatment of Postpartum Anemia With Compound E Jiao Jiang(cEJJ）

Postpartum Anemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06175117
• Other study ID #: DEEJ-CTP-20230724
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2023
• Est. completion date: November 2025

Study information

• Verified date: November 2023
• Source: DongE E Jiao Coporation Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: November 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with mild or moderate anemia (70g/L=Hb < 110g/L) within 1 week postpartum and suitable for oral drug therapy;

2. Age 18-45 years old (including 18 and 45);

3. 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;

4. Sign the subject's informed consent voluntarily.

Exclusion Criteria:

1. Postpartum hemorrhage and blood transfusion treatment;

2. 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;

3. Patients who have taken blood tonics within 1 week before screening, including other iron preparations and Chinese medicine or Chinese medicine preparations;

4. People with previous blood diseases such as sickle cell anemia, thalassemia, aplastic anemia, megaloblastic anemia;

5. Severe preeclampsia during pregnancy;

6. Abortion occurs in this pregnancy;

7. 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;

8. Severe hepatic and renal insufficiency (ALT >2×ULN, aspartate aminotransferase (AST)>2×ULN, Urea (Urea)/ urea nitrogen (BUN)>2×ULN, creatinine (Cr)>1×ULN);

9. People with a history of alcoholism, drug abuse, or drug abuse;

10. Allergic to the experimental drug or known ingredient;

11. Participants who had participated in other clinical trials within 3 months before screening;

12. Those who, according to the judgment of the investigator, consider it inappropriate to participate in this clinical trial.

Related Conditions & MeSH terms

• Anemia
• Postpartum Anemia

Intervention

Drug:
• compound E Jiao Jiang(cEJJ)
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
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. ferrous succinate tablet:1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DongE E Jiao Coporation Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edinburgh Postnatal Depression(EPDS) change value	The EPDS total score ranges from 0 to 30, and the higher the score, the severe the depression.	6 weeks
Other	Self-rating Anxiety Scale(SAS)change value	The SAS total score ranges from 0 to 80, and the higher the score, the greater the anxiety.	6 weeks
Other	Pittsburgh sleep quality index(PSQI) change value	The PSQI total score ranges from 0 to 21, and the higher the score, the worse the sleep quality.	6 weeks
Other	The Functional Assessment of Chronic Illness Therapy-Fatigue(FACIT-F) change value	The FACIT-F total score ranges from 0 to52, and the higher the score, the more fatigue.	6 weeks
Primary	Hemoglobin(Hb) change value	Hb changes after 6 weeks of continuous medication	6 weeks
Secondary	The proportion of hemoglobin returned to normal	Hb returned to normal proportions after 6 weeks of continuous medication	6 weeks
Secondary	The proportion of hemoglobin rising > 20g/L	The proportion of Hb increased >20g/L after 6 weeks of continuous administration	6 weeks
Secondary	The proportion of hemoglobin rising > 10g/L	The proportion of Hb increased >10g/L after 6 weeks of continuous administration	6 weeks
Secondary	serum iron change value	serum iron changes after 6 weeks of continuous medication	6 weeks
Secondary	serum ferritin change value	serum ferritin changes after 6 weeks of continuous medication	6 weeks
Secondary	Red Blood Cell(RBC) change value	RBC changes after 6 weeks of continuous medication	6 weeks
Secondary	Hematocrit(HCT )change value	HCT changes after 6 weeks of continuous medication	6 weeks
Secondary	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.	6 weeks