Health Condition 1: D50- Iron deficiency anemia
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male and non-pregnant female population having mild or moderate Iron Deficiency anemia (IDA) caused by different aetiology such as abnormal uterine bleeding and other conditions leading to significant blood loss prior to trial enrolment. 2. Hemoglobin ranges Non pregnant women mild: 110 to 119 g per l, moderate: 80 to 109 g per l. Men, 15 years and above mild: 110 to 129 g per l, moderate: 80 to 109g per l. 3. Transferrin saturation less than 20% 4. S-ferritin less than 30 µg per l. 5. Willingness to participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Anemia predominantly caused by factors other than Iron Deficiency Anemia e.g. anemia with untreated vitamin B12 or folate deficiency, sickle cell anemia, thalassemia minor. 2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis). 3. Pregnant or lactating women. 4. Known hypersensitivity to any excipients in the investigational drug products. 5. Erythropoietin treatment within 8 weeks prior to the screening visit. 6. Patients planning surgery within the trial phase or received a blood transfusion a week prior to the screening visit. 7. Any other medical condition that, in the opinion of investigator, make the patient incompetent to participate in the trial or place the patient at potential risk, e.g. any chronic comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in laboratory parameters compared to baseline after 3 months of Ayurvedic intervention. Change in laboratory parameter compared to baseline after 3 months of yogic practices. Timepoint: Baseline, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in sleep quality, quality of life, anxiety levels, fatigue, mood states and pain. Treatment satisfaction and adherence. Timepoint: Baseline, Day 45, Day 90 | — |
Countries
India
Contacts
Patanjali Yog Gram