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A multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Compound Ejiao Decoction in treating mild to moderate iron-deficiency anemia (syndrome of qi and blood deficiency) in elderly women

A multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Compound Ejiao Decoction in treating mild to moderate iron-deficiency anemia (syndrome of qi and blood deficiency) in elderly women

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001336
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-05-29
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate iron deficiency anemia in elderly women (Qi and blood deficiency syndrome)

Interventions

Experimental Group:Compound Ejiao Decoction+Ferric Succinate Tablets
Control group:Compound Ejiao Decoction Simulation Agent+Ferric Succinate Tablets

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following inclusion criteria: 1. Individuals meeting the diagnostic criteria for mild to moderate iron deficiency anemia; 2. conforms to the TCM syndrome differentiation of dual deficiency of qi and blood; 3. Female patients aged 60 to 80 years (inclusive); 4. Patients who have not received corrective anemia treatment within the past month; 5. The patient voluntarily participated in this study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of severe primary diseases affecting the heart, brain, lungs, liver, kidneys, endocrine system, nervous system, or hematopoietic system; 2. Patients with non-isolated iron deficiency anemias such as thalassemia, sideroblastic anemia, or megaloblastic anemia; 3. Patients with AST/ALT>1.5×ULN, Cr>1×ULN, and BUN>2×ULN; 4. Presence of intellectual disability, psychosis, or neurosis; 5. Patients with known or suspected history of allergy to the components of the investigational drug or to iron; 6. Participated in other clinical trials within the past 3 months; 7. Patients who have used other traditional Chinese medicine preparations or iron supplements for replenishing qi and nourishing blood within the past week; 8. Patients with allergies to traditional Chinese medicine; 9. Patients whom the investigator deems unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
HB;

Secondary

MeasureTime frame
RBC WBC PLT MCV MCH RDW;SF SI TIBC TSAT;TCM Syndrome Score;PSQI SF-36 SNAQ;

Countries

China

Contacts

Public ContactYingqun Chen

Shanghai Tenth People's Hospital

dr.chenyq@vip.163.com13816902028

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026