CTRI/2023/04/051785已完成4 期
Evaluation of the effectiveness of Livogen Z® (Ferrous Fumarate, Folic Acid and Zinc Sulphate) Fixed Dose Combination in Iron Deficiency Anemia – An Open Label, Single arm, Phase IV, Post Marketing, Observational Study (LIBERTY)
Procter and Gamble Health Limited0 个研究点目标入组 102 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Female subjects with known IDA as per WHO criteria to whom Livogen Z® will be prescribed per routine clinical practice of the investigator.
- •IDA as per WHO criteria
- •1. Non-Anemia (g. dL)
- •a. Non-pregnant women (age > 15 years or above) = 12 or higher
- •b. Pregnant women (age > 15 years or above) = 11 or higher
- •2. Anemia (g. dL)
- •A. Non-pregnant women (age > 15 years or above)
- •a. Mild (Non-pregnant women) 11 to 11.9
- •b. Moderate (Non-pregnant women) 8 to 10.9
- •c. Severe (Non-pregnant women) Lower than 8
- •B. Pregnant women (age > 15 years or above)
- •a. Mild (Pregnant women) 10 to 10.9
- •b. Moderate (Pregnant women) 7 to 9.9
- •c. Severe (Pregnant women) < 7
- •2. Subjects willing to provide written informed consent
- •3. Subject aged > 18 to = 55 years
- •4. Subjects willing to comply with the prescribed treatment regimen for the duration of study participation.
排除标准
- •Subjects will be excluded if they meet any of the following criteria:
- •1. Subjects with a severe case of anemia requiring blood transfusions.
- •2. Subjects with anemia, which in the opinion of the investigator is caused by known conditions other than dietary deficiency including:
- •a. Pernicious anemia
- •b. Thalassemia
- •c. Sickle cell or aplastic anemia
- •d. Active peptic ulcer
- •e. Regional enteritis
- •f. Ulcerative Colitis
- •g. Hemorrhoids
- •h. Esophageal varices
- •i. Helminthiasis
- •j. Megaloblastic anemia
- •k. Porphyria cutanea tarda
- •3. Subjects with folate dependent tumours.
- •4. Subjects with serious gastrointestinal disorders,(e.g., inflammatory bowel disease,
- •intestinal strictures and diverticulae), who cannot take iron therapy by mouth.
- •5. Subjects with any known autoimmune disease.
- •6. Malnourished subjects who also have a known underlying infection that interferes with iron absorption.
- •7. Subjects with primary or secondary hemochromatosis or who are known to have a risk for iron overload.
- •8. Subjects with IDA in whom oral therapy has failed in clinical practice.
- •9. Subjects with an acute bleeding condition.
- •10. Subjects who have become pregnant with assisted reproduction technology (like In-vitro Fertilization (IVF), etc.)
- •11. Pregnant subjects in their third trimester gestation week 27 onwards.
- •12. Pregnant subjects with gestational diabetes or hypertension.
- •13. Subjects with bleeding disorders. (e.g. blood dyscrasia, subjects with hemophilia, thrombocytopenia, low platelets, coagulopathy, etc.)
- •14. Subjects suffering from severe or uncontrolled systemic or metabolic diseases.
- •15. Pregnant subjects with multifetal pregnancy.
- •16. Subjects who have taken hematinic agents (except Livogen Z®) /supplements
- •continuously for two weeks with a daily dose of elemental iron =27 mg in pregnant subjects, =18mg in non-pregnant subjects and within 4 weeks prior to study start.
- •17. Subjects with severe concurrent illness (cardiovascular, renal, hepatic), and with any
- •other condition that in the opinion of the investigator does not justify the inclusion of
- •the subject in the study.
- •18. Subject whose lifestyle (including diet and food intake) would, in the Investigator’s
- •judgment, affect the subject’s participation in the study.
- •19. Subjects who have participated in any other clinical trial in the past 30 days from the study start.
研究者
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