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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Postpartum Anemia
• Intervention / Treatment: Drug: compound E Jiao Jiang(cEJJ); Drug: compound E Jiao Jiang(cEJJ) placebo

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)：20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.; Other Names: ferrous succinate tablet（1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.）
Placebo Comparator: 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; 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.; Other Names: ferrous succinate tablet（1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin（Hb） change value	Hb changes after 6 weeks of continuous medication	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of hemoglobin returned to normal	Hb returned to normal proportions after 6 weeks of continuous medication	6 weeks
The proportion of hemoglobin rising > 20g/L	The proportion of Hb increased >20g/L after 6 weeks of continuous administration	6 weeks
The proportion of hemoglobin rising > 10g/L	The proportion of Hb increased >10g/L after 6 weeks of continuous administration	6 weeks
serum iron change value	serum iron changes after 6 weeks of continuous medication	6 weeks
serum ferritin change value	serum ferritin changes after 6 weeks of continuous medication	6 weeks
Red Blood Cell（RBC） change value	RBC changes after 6 weeks of continuous medication	6 weeks
Hematocrit（HCT ）change value	HCT changes after 6 weeks of continuous medication	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.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: DongE E Jiao Coporation Limited

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Anti-Inflammatory Agents; Hematinics; Cortisone; Ferrous succinate
• Other Study ID Numbers: DEEJ-CTP-20230724

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No