A double-blind, randomized, comparative 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/adjuvant to the treatment. - Anemia

YourZooki holdings Ltd0 sites60 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 10, 2023

Last Updated

2 years ago

Study Type

Interventional

Sponsor

YourZooki holdings Ltd

•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.