Health Condition 1: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Conditions
Interventions
Intervention1: Hemoday Plus 30
: 30 mg capsules
Oral dose
For 90 days
Control Intervention1: Hemoday 40 plus
: 40 mg capsules
Oral dose
For 90 days
Sponsors
GC Chemie Pharmie Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Age � 18 years at recruitment. Pregnant women between 16 and 28 weeks of gestation diagnosed with Iron deficiency Anemia Haemoglobin between 7 to 9gm% Treatment New Patients Singleton Pregnancy Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
Exclusion criteria
Exclusion criteria: Within two months of starting iron therapy. Multiple pregnancy History of previous or repeated blood transfusion. History of haematological disease. Hemodynamic instability or clinically perceived or anticipated need of blood transfusion Risk of preterm labour. Pregnant women with any other comorbidities such as renal or hepatic impairment, cardiovascular diseases, preeclampsia, GDM, thyroid disorders, acid peptic disease, esophagitis and malabsorption syndrome. Treatment with any other investigational drug in the last 1 month before study entry Current usage of iron supplement High risk pregnancy. Women who are unable to give informed consent. Women who have intolerant to iron derivatives, Patients suffering from any bleeding disorder like bleeding piles or active peptic ulcer. Women with antepartum haemorrhage and those who delivered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Haemoglobin from Baseline to Day 90 within the treatment arm. Change in Ferritin Level from Baseline to Day 90 within the treatment arm. Timepoint: Day 30, 60, 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Haemoglobin from Baseline to Day 90 within the treatment arm. Change in Ferritin Level from Baseline to Day 90 within the treatment arm. Correlation between the weeks of gestation and improvement in haemoglobin and ferritin level will be assessed from baseline to day 30, Day 60 and Day 90. Proportion of patient with treatment emergent adverse event within the treatment group.Timepoint: Day 30, 60, 90 | — |
Countries
India
Contacts
Public ContactDr R Senthurselvi
MBBS MD
Outcome results
None listed