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A single-center, self-controlled before and after (one-arm) clinical study to observe the efficacy and safety of oral polysaccharide iron complex capsules in the treatment of iron deficiency anemia caused by abnormal uterine bleeding caused by uterine fibroids

A single-center, self-controlled before and after (one-arm) clinical study to observe the efficacy and safety of oral polysaccharide iron complex capsules in the treatment of iron deficiency anemia caused by abnormal uterine bleeding caused by uterine fibroids

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073910
Enrollment
Unknown
Registered
2023-07-25
Start date
2021-03-04
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Iron deficiency anemia due to abnormal uterine bleeding caused by uterine fibroids

Interventions

Experimental group:Basic treatment + polysaccharide iron complex capsule (oral, 1 capsule/time, once a day)

Sponsors

Beijing Maternity Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Meet the relevant diagnostic criteria of iron deficiency anemia caused by abnormal uterine bleeding caused by uterine fibroids and belong to preoperative pretreatment patients; (2) Patients who received GNRH-a hemostatic treatment first, and at the same time were given oral "Yangxue Yin oral liquid" to treat anemia, and bleeding stopped; (3) Patients with mild to moderate anemia (mild to moderate anemia 60g/L=Hb<110g/L); (4) Aged between 20 and 55 (including endpoint values); (5) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Severely damaged liver and kidney function (liver function: ALT, AST more than 2 times the upper limit of normal value; Renal function: GFR < 60ml/min), especially in patients with untreated urinary tract infection; (2) Patients who have taken sex hormone drugs for treatment of other diseases within three months; (3) High iron load, haemochromatosis or hemosiderosis; (4) Patients with severe cardiovascular and cerebrovascular diseases (such as coronary atherosclerosis, cerebral hemorrhage, cerebral thrombosis, etc.); (5) Alcoholism, hepatitis, acute infection, intestinal inflammation, pancreatitis, gastric and duodenal ulcer, ulcerative enteritis; (6) Pregnant and lactating women; (7) Allergic to iron; (8) Patients with severe speech and cognitive impairment; (9) Participating in other drug clinical researchers; (10) Participation in clinical research is not considered appropriate by the research physician.

Design outcomes

Primary

MeasureTime frame
Blood routine index test: hemoglobin (Hb) and red blood cell count (RBC);Detection of four indexes of iron: serum iron (SI), transferrin (TRF), ferritin (SF), total iron binding capacity (TIBC);

Countries

China

Contacts

Public ContactLu Dan

Beijing Maternity Hospital Affiliated to Capital Medical University

ludan6268@163.com+86 10 5227 2525

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026