A parallel group study to demonstrate the safety and efficacy of two molecules i.e. ferrous bisglycinate chelate and ferrous ascorbate in female patients with iron deficiency anaemia.
- Conditions
- Health Condition 1: null- Iron Deficiency Anaemia
- Registration Number
- CTRI/2011/11/002109
- Lead Sponsor
- GlaxoSmithKline Pharmaceuticals LtdAddress AB Road Worli Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 270
Signed and dated written informed consent is obtained prior to participation.
Female outpatients between 18 to 55 years of age and using effective method of contraception if sexually active.
Non use of any iron supplement for 3 months prior to enrolment to the study.
Presence of iron deficiency anaemia: low haemoglobin (Hb 6-9 gm/dl) + low serum ferritin (15 μg/l).
No occult blood in stool.
Able to comply with the requirements of the protocol.
Subjects should have a valid telephone contact.
Pregnancy (confirmed by urine dipstick method)
Desire to conceive within the next 3 months including patients who are receiving treatment to facilitate conception.
Lactating women.
Medical history of current hematological disorders other than iron deficiency anaemia (e.g. aplastic anaemia, megaloblastic anaemia, sideroblastic anaemia, pernicious anaemia, thalassemia, sickle cell anaemia, etc.).
Medical history of thyroid dysfunction.
Medical history of chronic renal disease.
Medical history of malabsorption syndrome, haemochromatosis and haemosiderosis, hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy.
Inability to withhold prohibited medication.
Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator.
Clinically significant abnormality in laboratory reports and/or ECG.
Medical history of hepatitis B, hepatitis C and/or exposure to HIV.
Serious, uncontrolled disease (other than thyroid dysfunction and chronic renal disease) including serious psychological disorders likely to interfere with the study and/or likely to cause death within the study period.
Participation in another clinical trial in the last 8 weeks before entry to Visit 0.
Evidence of alcohol or drug abuse, that may, in the opinion of the investigator interfere with study compliance or prevent understanding of the objectives, investigational procedures or possible consequences of the study.
Known or suspected hypersensitivity to iron or any of the components of Ferronine or Orofer XT tablets.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Hemoglobin Rise in each ferrous bisglycinate chelate group (1 tablet daily and 2 tablets daily).Timepoint: every 2 Weeks upto 8 weeks
- Secondary Outcome Measures
Name Time Method