Health Condition 1: D899- Disorder involving the immune mechanism, unspecified
Conditions
Interventions
Intervention1: Capsule Feroglobin: Dose One capsule, frequency once daily with main meal,Oral route of administration for 90 days
Control Intervention1: Standard of care: Standard of care oral iron su
Sponsors
Meyer Organics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male and females with the age between 18-65 years old (Both inclusive); 2.Subjects presenting with fatigue scoring between 18 to 54 based on-Fatigue Severity Scale (FSS) at screening; 3.Serum ferritin levels lower than 50 mcg/L (iron deficiency); 4.Hemoglobin levels =11 g/dL in non-pregnant women and men (mild anemic to non-anemic patients, defined by WHO); 5.Subjects with or without comorbidity, if comorbid, should be with stable prescription for last three months; 6.Able to give written informed consent; 7.Able to follow up through visits.
Exclusion criteria
Exclusion criteria: 1.Previous diagnosis of any concurrent disease or medical and/or surgical condition as a possible cause of fatigue or iron deficiency; 2.Medical history of current hematological disorders other than iron deficiency anemia (e.g. aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia, sickle cell anemia, etc.). 3.Medical history of malabsorption syndrome, hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy; 4.Patients who are eligible for IV iron replacement therapy. 5.Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator 6.Any treatment with any vitamin and mineral supplements prior to inclusion to the study in the last 3 months’ period; 7.Participants on dialysis or with an estimated glomerular filtration rate 8.Ongoing or history of malignancy within past 3 years; 9.Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 4 weeks postpartum, or have a positive serum/urine pregnancy test; 10.Known or suspected hypersensitivity to iron or any of the components of investigational products; 11.Not being competent to complete study questionnaires as per discretion of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in patient response to Fatigue Severity Scale (FSS)Timepoint: Screening, visit 1,visit 2, and visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in blood hemoglobin and ferritin levels 2.Changes in quality of life (QoL) using SF-36 questionnaire at screening and visit 3. 3.Assessment of gastrointestinal adverse effects utilizing a symptoms questionnaire 4.Treatment adherence via assessment of compliance questionnaire directed to patients at visit 1, visit 2 and visit 3.Timepoint: Screening, visit 1,visit 2, and visit 3 | — |
Countries
India
Contacts
Public ContactNeepa Gaba
Meyer Organics Pvt. Ltd.
Outcome results
None listed