Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council of Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of any gender aged 18-60 years and diagnosed with IDA 2.Mean corpuscular volume (MCV) below 80 fl. 3.Hemoglobin 8-10.9 gm/dl (as per WHO) 4.Willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1.Iron deficiency due to blood loss from the intestine or other sites. 2.Other causes of anemia, apart from iron deficiency, apparent by history, physical examination, and/or laboratory tests. 3.Iron deficiency anemia necessitating parenteral iron therapy 4.Intake of Iron supplements for three months before the initiation of the study. 5.Participants with Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) 6.Participants with Renal Dysfunction (defined as S. creatinine >1.2 mg/dl); 7.History of uncontrolled bronchial asthma, cardiovascular disease, cerebrovascular disease, psychiatric illness, tuberculosis, HIV, malignancy, etc. 8.Patients suffering from major systemic illnesses necessitating long-term treatment (Psycho-neuro-endocrinal disorders, etc.) 9.Hormone therapy (including the use of androgens/anabolic steroids) or administration of drugs that affect erythropoiesis, less than three months before the start of the study. 10.Female participants who are pregnant, intend to become pregnant, are breastfeeding, or not willing to use effective contraceptive precautions during the study. 11.History or active substance abuse 12.History of hypersensitivity to the trial interventions or their ingredients. 13.Any other condition that in the opinion of the investigator may compromise the participantâ??s safety or compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of the tolerability of the Ayurvedic intervention through reported incidence of treatment-emergent adverse events & serious adverse events during the study period [ Time Frame: [Baseline to day 90] 2.Assessment of treatment adherence through self-reported compliance log & used medication containers/strips. [Time frame: Baseline, 30th day, 60th day, 90th day]Timepoint: Baseline, 30th day, 60th day, 90th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of participants who withdrew/dropped out from the study due to adverse events and/or poor tolerability [Time frame: Baseline, 30th day, 60th day, 90th day] 2.Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) [Time frame: Baseline, 90th day] 3.Mean change in Hemoglobin% from [Time frame: Baseline, 30th day, 60th day, 90th day] 4.Change in haematological parameters (total RBC count, RBCs indices & Absolute Reticulocyte count) from baseline[Time frame: Baseline, 90th day] 5.Changes in parameters of Iron profile (Serum Iron, ferritin & transferrin saturation levels) from baseline [Time frame: Baseline, 90th day] 6.Proportion of participants who attained Hb% within the mild range (defined as Hb 11-11.9 g/dl as per WHO) [Time frame: Baseline, 30th day, 60th day, 90th day] 7.Change in fatigue levels from baseline assessed through FACIT Fatigue Scale to evaluate fatigue severity (FACIT-F) [Time frame: Baseline, 30th day, 60th day, 90th day]Timepoint: Baseline, 30th day, 60th day, 90th day | — |
Countries
India
Contacts
Public ContactDr Seema Jain
Central Ayurveda Research Institute
Outcome results
None listed