CTRI/2021/07/035277
Other
Phase 3
An Open Label, Multicentre, Single Arm Clinical Trial to Determine the Efficacy and Safety of Hemoday Manufactured By G. C. Chemie PharmieLtd in Iron Deficiency Anemia in Pregnant Women.
GC Chemie Pharmie Ltd0 sites4 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GC Chemie Pharmie Ltd
- Enrollment
- 4
- Status
- Other
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ââ?°Â¥ 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
- •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.
Outcomes
Primary Outcomes
Not specified
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