Health Condition 1: D508- Other iron deficiency anemias
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences (CCRAS)
Eligibility
Inclusion criteria
Inclusion criteria: i. Children of EMR School having age between 10-18 years of any gender with moderate anemia (Hb 8-10.9 g/dl) ii. Child Assent and Parents/guardian willing to provide a written informed consent form for the participation of their children iii. Students who had no intention of leaving the schools until the end of the study will be included in this study.
Exclusion criteria
Exclusion criteria: i. Students already on daily Iron supplement. ii. Students not willing to take the Ayurveda interventions. iii. Known cases of diseases interfering with iron absorption like celiac disease, Helicobacter pylori infection, autoimmune gastritis, or anemia of chronic disease. iv. Known cases of gastrointestinal blood loss evaluated by asking positive stool occult blood loss. v. Known cases of Cow milk protein intolerance, Meckel diverticulum and inflammatory bowel disease. vi. Known cases of microcytic hypochromic anemia due to Celiac disease and betathalassemia trait (BTT). vii. Known cases of Anemia of chronic diseases with underlying chronic renal disease or connective tissue disease. viii. Known cases of Iron refractory iron deficiency anemia (IRIDA). ix. Known cases of Folate or Vit B12 deficiency Anemia, Pernicious Anemia x. Known cases of Diabetes mellitus, malignancies, bleeding disorders, serious systemic illnesses, Hemoglobinopathies, Menometrorrhagia, inflammatory disorders, xi. Students having family history of hemoglobinopathies xii. Child with congenital abnormalities needing medical/surgical intervention xiii. Students on medications which interfere with study outcome measurements. xiv. Participants with Vit B12 deficiency (below 200pg/ml)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin level as compared to baseline. [Time frame: at baseline, and at the end of 3rd month]Timepoint: At baseline and at the end of 3rd month | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Assessment of the tolerability through reported incidence of treatment-emergent adverse events and serious adverse eventsTimepoint: Baseline, 1st month, 2nd Month, 3rd Month;ii. Assessment of treatment adherence through self-reported compliance log and used medication containers/stripsTimepoint: Baseline, 1st month, 2nd Month, 3rd Month;iii. Proportion of participants achieving increase in the hemoglobin level by at least 0.5 gm%Timepoint: From Baseline to end of 3rd month;iv. Change in fatigue symptoms as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue ScaleTimepoint: From baseline to end of 1st month, end of 2nd month, end of 3rd month | — |
Countries
India
Contacts
Public ContactDr Renu Singh
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed