Study of Darvyadi Leha in anemia of childre
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2022/07/044074
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Hemoglobin 7.5-11gm/dl
1.Other causes of anemia, apart from iron deficiency, apparent by history and physical examination
2.Known cases of hemoglobinopathies especially Thalassemia.
3.Iron deficiency likely or definitely due to blood loss from the intestine or other sites
4.Hemoglobin below 7.5gm/dl.
5.History or evidence of intestinal malabsorption or any GIT pathology which may hamper the oral iron therapy administration
6.Hypersensitivity to iron therapy and other components of the study drugs.
7.Known cases of chronic debilitating illness like TB, Juvenile Diabetes etc.
8.Patients with concurrent Hepatic disease, Renal disease, Bronchial Asthma, Cardiovascular disease.
9.Any other clinical condition which may impact the study outcomes as per the study investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HemoglobinTimepoint: At baseline, 30 days, 60 days, 90 days, 120 days
- Secondary Outcome Measures
Name Time Method 1. Proportion of participants who attained Hb within the normal reference range (defined as Hb â?¥11 g/dl) <br/ ><br>2. Change in ferritin levels <br/ ><br>3.RBC count, MCV and MCH <br/ ><br>4.Absolute Reticulocyte count <br/ ><br>Timepoint: At baseline and at 90 days