A clinical study to evaluate the safety and efficacy of study drug for iron repletion in adult male or female patients suffering with iron deficiency anaemia as supplement to the treatment.
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2023/07/055267
- Lead Sponsor
- YourZooki holdings Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Patients of either gender 18 to 70 years (inclusive)
Subjects giving written informed consent /assent form
Patients having presence of iron deficiency anemia below normal or low hemoglobin as per lab reports.
Non-use of any iron supplement for 2 weeks prior to enrolment to the study and to know the dosage timing of Calcium supplement if any.
Willing to come for regular follow-up visits.
In the opinion of the investigator, able to comply with the requirements of the protocol.
Patients with serious cardiovascular, cerebro-vascular respiratory liver or renal disease or any other disorder.
Known history of hypersensitivity to herbal extracts or dietary supplements. Known or suspected hypersensitivity to iron or any of the components of Investigational Product.
Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy.
Medical history of current hematological disorders other than iron deficiency anemia (e.g. aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia, sickle cell anemia, etc.).
Evidence of alcohol or drug abuse, that may, in the opinion of the Investigator interferes with study compliance or prevents understanding of the objectives, investigational procedures or possible consequences of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method