This is a single center study wherein the safety and efficacy of Bio-Iron tablets will be studied in male or female patients suffering from Iron deficiency anaemia.
- Conditions
- Health Condition 1: null- Iron deficiency anaemiaHealth Condition 2: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2016/03/006744
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Complete Blood Count <br/ ><br>2 Erythrocyte Sedimentation Rate <br/ ><br>3 Red blood cell indices <br/ ><br>4 Serum iron, total iron binding capacity and serum ferritin <br/ ><br>5 SF-36 questionnaire <br/ ><br>6 Fatigue Severity ScaleTimepoint: 1 Complete Blood Count(Screening,Day14 & Day56) <br/ ><br>2 Erythrocyte Sedimentation Rate(Screening,Day14 & Day56) <br/ ><br>3 Red blood cell indices(Screening,Day14 & Day56) <br/ ><br>4 Serum iron, total iron binding capacity and serum ferritin(Screening & Day56) <br/ ><br>5 SF-36 questionnaire(Screening & Day56) <br/ ><br>6 Fatigue Severity Scale(Screening & Day56)
- Secondary Outcome Measures
Name Time Method 1 Adverse/Serious Adverse events <br/ ><br>2 Abnormal vital signsTimepoint: 1 Adverse/Serious Adverse events(Day0,Day14,Day28 & Day56) <br/ ><br>2 Abnormal vital signs(Screening,Day0,Day14,Day28 & Day56)