Safety and efficacy of Himfera capsules in the Management of Anaemia
- Conditions
- Health Condition 1: null- individuals with Iron Deficiency Anaemia (IDA)
- Registration Number
- CTRI/2018/04/013431
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects of both sexes in the age group of 18-70 years with Hemoglobin <11gm/dL.
2.Subjects who have clinical symptoms such as pale skin colour, extreme fatigue, irritability, weakness, brittle nails, palpitation, headache, loss of appetite.
3.Subjective improvement in quality of life in subjects with Iron deficiency anaemic.
4.Subjects willing to give written informed consent.
5.Subjects who have not participated in similar kind of study in last 3 months.
•Subjects with hemoglobin concentration < 6 gm/dl, patients of thalassaemia, sickle cell anemia, aplastic anemia, haemolytic anemia, lead poisoning, sideroblastic anaemia, malignancies, congenital.
•Blood hemoglobin level < 5 gm/dl during the course of any treatment, any other acute illness, severe untoward effect.
•Absence of iron binding protein, hereditory spherocytosis and any association of severe complication.
•Pregnant & lactating women.
•Not willing to sign informed consent form.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in anaemia-related blood parameter levels <br/ ><br>â?¢An improvement in biochemical parameters viz. serum iron hemoglobin levels and erythrocyte counts. <br/ ><br>â?¢Improvement in symptoms such as skin pallor, tiredness and lack of energy, headache, weakness, low performance, appetite, breathlessness and feeling of wellbeing. <br/ ><br>â?¢Subjective improvement in quality of life in subjects with Iron deficiency anaemic <br/ ><br>Timepoint: Patients will be followed up and the results were assessed from baseline on visit days: <br/ ><br>Visit 0- Baseline <br/ ><br>Visit 1 - At the end of Month 1 <br/ ><br>Visit 2- At the end of Month 2 (End of the study) <br/ ><br>
- Secondary Outcome Measures
Name Time Method Compliance of the subject to the drug treatment and the adverse effects will be noted.Timepoint: Patients will be followed up and the results were assessed from baseline on visit days: <br/ ><br>Visit 0- Baseline <br/ ><br>Visit 1 - At the end of Month 1 <br/ ><br>Visit 2- At the end of Month 2 (End of the study) <br/ ><br>