Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex aged between 12 and 18 years. 2. Subjects of either sex having Hemoglobin levels between 8-11gm% 3. Willing and able to participate in the trial
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Subjects suffering from any other type of anemia such as Anemia of chronic diseases, megaloblastic anemia, sideroblastic anemia, hemolytic anemia 2. Any inherited blood disorder such as Thalassemia, aplastic anemia, sickle cell anemia • 3. A history or a diagnosis of Acute myelogenous or lymphoblastic leukemia, Multiple myeloma, Primary or secondary myelodysplastic syndrome, hemochromatosis • 4. Use of any iron-containing drugs or treatment for anemia during the last 3 months. • 5. Known hypersensitivity to oral iron or any component of the trial intervention • 6. Participants with conditions necessitating parenteral iron therapy such as impaired absorption due to diseases such as inflammatory bowel disease, blood loss, etc. • 7. Subjects with evidence of malignancy, chronic infectious diseases, auto immune diseases 8. Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics etc. or any other drugs that may have an influence on the outcome of the study. 9.Patients with concurrent serious hepatic disorder or Renal Disorders Severe Pulmonary Dysfunction or cardiac diseases. 10. Patients who have completed participation in any other clinical trial during the past six (06) months. 11. Any other condition which the Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Mean change in Hb level and indices such as MCHC, MCV, MCHTimepoint: Hb on baseline, 14th day, 28th day, 56th day, 84th day Other parameters on baseline and 84th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: â?¢ Mean change in Serum Iron and ferritin level, TIBC, TSAT â?¢ Mean change in Montreal cognitive assessment scale â?¢ Mean change in Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders â?? Child (R4PDQ) â?¢ Mean change in HR QoL (Health Related Quality of Life) â?¢ Percentage change in symptoms of IDA: weakness, fatigue, dizziness, headache, palpitation, shortness of breath, irritability, taste disturbances, pallor, brittle nails, pica, glossitis, angular stomatitis, ringing in the ears. â?¢ Incidence of GI related and other adverse events â?¢ Medication Adherence Timepoint: Baseline and 84th day | — |
Countries
India
Contacts
Public ContactDr Remya E
NARIP, Cheruthuruthy
Outcome results
None listed