Health Condition 1: E611- Iron deficiency
Conditions
Interventions
Intervention1: HIA-10-23: Oral dose, 500 mg/day for 120 days
Control Intervention1: Placebo: Oral dose, 500 mg/day for 120 days
Sponsors
Akay Natural Ingredients Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study 2 Subjects with low serum ferritin level(â?¹30mg/L) 3 Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
Exclusion criteria
Exclusion criteria: 1.Subjects with severe Iron deficiency anemia 2.Subjects who are pregnant or lactating 3.Subjects with raised inflammatory markers (CRP >1 mg/l or ESR >20 mm/1st hour). 4.Subjects having specific symptoms attributable to upper gastro-intestinal (GI) tract disease. 5.Patients who had major surgery or invasive intervention within 4 weeks prior to screening, or intervention planned during the course of the study. 6.Subjects having history of •Uncontrolled hypertension •Coronary artery disease, Angina, tread mill test (TMT) positive for inducible ischemia •Psychiatric illness •Drug abuse, smoking, abuse/addiction to alcohol •Endocrine abnormalities including stable thyroid disease •Cardiovascular surgery Patients with hemochromatosis or other iron storage disorders. 7.Subjects currently or have history of smoking more than 10 cigarettes per day 8.Donation or loss of blood or plasma: 50 mL or more within 60 days prior to the administration of study medication 9.Subjects who maybe allergic to any of the natural constituents of the Investigational Product. 10.Subjects with history of severe Covid-19. 11.Known HIV or Hepatitis B positive or any other immuno-compromised state 12.Subjects on any other medical or clinical investigation or on any nutrition supplements and dietary regime.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in serum Iron after the supplementation of HIA-10-23 compared to placebo.Timepoint: 0.00h, 1.00h 2.00h 3.00h 4.00h 6.00h 8.00h 12.00h , Day 90, Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in hemoglobin (Hb) profile, Complete Blood Count, Serum Ferritin, Total Iron Binding Capacity & Transferrin saturationTimepoint: Day 0, Day 90 & Day 120;Questionnaire based assessments for Safety and EfficacyTimepoint: Day 0, Day 90 and Day 120 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed