Health Condition 1: null- Iron deficiency anaemia Health Condition 2: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Bio-Iron: One tablet b.i.d. before food for a period of 56 days.
Control Intervention1: NIL: NIL
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male & female outpatients between 18 to 55 years. 2 Presence of iron deficiency anaemia:below normal or low haemoglobin. 3 Using effective method of contraception if sexually active. 4 Willing to come for regular follow-up visits. 5 Able to give written informed consent. 6 Non-use of any iron supplement for 2 weeks prior to enrolment to the study and to know the dosage timing of Calcium supplement if any. 7 Able to comply with the requirements of the Protocol.
Exclusion criteria
Exclusion criteria: 1 Known history of hypersensitivity to herbal extracts or dietary supplements. 2 Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test. 3 Medical history of current haematological disorders other than iron deficiency anaemia (e.g. aplastic anaemia, megaloblastic anaemia, sideroblastic anaemia, pernicious anaemia, thalassemia, sickle cell anaemia, etc.). 4 Medical history of chronic renal disease. 5 Medical history of malabsorption syndrome, hemochromatosis. 6 Obvious internal or external bleeding as documented by medical history. 7 Medical history of hepatitis B, hepatitis C and/or exposure to HIV. 8 Participation in another clinical trial in the last 8 weeks before entry to Visit 0. 9 Evidence of alcohol or drug abuse, that may, in the opinion of the Investigator interferes with study compliance or prevents understanding of the objectives, investigational procedures or possible consequences of the study. 10 Known or suspected hypersensitivity to iron or any of the components of Investigational Product. 11 History of any recent surgeries undergone within past 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Complete Blood Count 2 Erythrocyte Sedimentation Rate 3 Red blood cell indices 4 Serum iron, total iron binding capacity and serum ferritin 5 SF-36 questionnaire 6 Fatigue Severity ScaleTimepoint: 1 Complete Blood Count(Screening,Day14 & Day56) 2 Erythrocyte Sedimentation Rate(Screening,Day14 & Day56) 3 Red blood cell indices(Screening,Day14 & Day56) 4 Serum iron, total iron binding capacity and serum ferritin(Screening & Day56) 5 SF-36 questionnaire(Screening & Day56) 6 Fatigue Severity Scale(Screening & Day56) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Adverse/Serious Adverse events 2 Abnormal vital signsTimepoint: 1 Adverse/Serious Adverse events(Day0,Day14,Day28 & Day56) 2 Abnormal vital signs(Screening,Day0,Day14,Day28 & Day56) | — |
Countries
India
Contacts
Public ContactMr Hasan Ahmed
ClinWorld Private Limited
Outcome results
None listed