FLIPS: Ferfer Liposomal Iron Performance Study

PharmEvo Pvt Ltd400 enrolled

Overview

To evaluate the efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin and Haematocrit levels

Anemia, described as a low blood Haemoglobin concentration, has been shown to be a public health problem that impacts low-, center- and high-earnings nations and has great unfavorable health results, as well as unfavorable influences on social and monetary development . even though the most dependable indicator of anemia on the populace stage is blood Haemoglobin attention, measurements of this attention by myself do now not determine the cause of anemia. Anemia may additionally result from a number of causes, with the maximum great contributor being iron deficiency. approximately 30%- 50% of instances of anemia are taken into consideration to be because of iron deficiency. Doctor will evaluate on the basis of inclusion or exclusion criteria, lab values and overall assessment and then enroll in this clinical trial. During the study patient will visit the Doctor four times, Day 0 week 4, week 8 and week 12. Doctor will investigate the Hemoglobin level and Hematocrit level and also evaluate the adverse effects and tolerability of Ferfer® at week 2 and week 8. Doctor also instructed to take the food supplements, twice daily, once in a morning and once in evening independently by food intake as Ferfer® has no interaction with food.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Iron Deficiency Anemia

Interventions

Iron SupplementDRUG

Ferfer® is a multi-ingredient supplement containing micro-encapsulated iron pyrophosphate (to form liposomes), vitamin C and vitamin B12 which are valuable for the control of nutritional deficiencies or increased organic needs of iron.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Iron deficiency anemia (Hemoglobin \<8 to \>5 g/dl) * Subjects able to provide written informed consent; * Subjects already treated with other iron supplements or drugs that experienced side effects (not including allergy) related to iron administration. * Wash out period will be a week Exclusion Criteria: * Had a history of iron intolerance * Hypersensitivity and allergic of Vit C and Vit B12 * Not willing to take informed consent

Locations (1)

Lubna Shahzad,Al-raheem surgical and Maternity Hospital, Daroghwala

Lahore, Sindh, Pakistan

Outcomes

Primary Outcomes

Efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin levels

To determine the efficacy of a novel food supplement,Ferfer® to raise the capacity of Haemoglobin levels Designated as safety issue: No

Time frame: Week 12

Secondary Outcomes

Adverse Event

Number of Participants Who Experienced an Adverse Event \[ Designated as safety issue: Yes \]

Time frame: upto 12 weeks

Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels

To determine the efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels

Time frame: Week 12

Data from ClinicalTrials.gov

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