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Clinical Trial Summary

This study is a prospective, open and non-interventionalclinical study. It is planned to enroll 240 patients with iron deficiency anemia caused by uterine fibroids and adenomyosis in 4 centers of obstetrics and gynecology in China.All patients who met the inclusion criteria and agreed to participate in the study received routine blood tests, serum ferritin, serum iron and total iron binding ability tests and clinical follow-up. All patients were given 15ml oral protein iron succinate solution (Fiapril) in the morning and evening each day.Blood routine examinations (Hb, reticulocytes, RBC, HCT), serum ferritin, serum iron and total iron binding ability were detected at the 1st, 4th, 8th and 12th weeks of the study to observe the change trend of their own indicators.Symptom self-assessment tables were collected to assess the improvement rate of clinical symptoms including dizziness, fatigue, chest tightness and palpitations, and to record the incidence of adverse reactions (mainly gastrointestinal reactions).


Clinical Trial Description

This project is a prospective, open, non-interventionalclinical study. It is planned to enroll 240 patients with iron deficiency anemia caused by uterine fibroids and adenomyosis in the department of obstetrics and gynecology in 4 centers nationwide. All patients who met the inclusion criteria and agreed to participate in the study received routine blood tests, serum ferritin, serum iron and total iron binding ability tests and clinical follow-up. All patients were given 15ml Iron Proteinsuccinylate Oral Solution in the morning and evening each day. Evaluation of therapeutic efficacy: Blood routine examinations (Hb, reticulocytic cell, RBC, HCT), serum ferritin, serum iron and total iron binding force were collected at week 1, 4, 8 and 12 of the study. Patients self-rated clinical symptoms such as dizziness, fatigue, chest tightness and palpitations.To evaluate laboratory measures of improvement and response rate (symptom relief) in patients with uterine fibroids and adenomyosis induced iron deficiency anemia presented to the department of obstetrics and gynecology, and the incidence of complications during the study period。 Patients with iron deficiency anemia caused by uterine fibroids and adenomyosis in the department of obstetrics and gynecology included in this study group were followed up for 12 weeks.The results of patients' self-assessed symptoms, including blood routine (Hb, reticulocyte, RBC, HCT), serum ferritin, serum iron, total iron binding ability and other indicators, as well as the occurrence of complications at baseline level and during short-term follow-up of 12 weeks, will be collected to determine the clinical outcomes of patients through hospital follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05192291
Study type Observational
Source Lee's Pharmaceutical Limited
Contact ningzhou xue, master
Phone 13156212575
Email [email protected]
Status Not yet recruiting
Phase
Start date February 1, 2022
Completion date February 1, 2023