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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Ferfer is a food supplement in liposomal form, with essential, vitamins including Vitamin C and Vitamin B12. Ferfer directly dissolves in the mouth without the need for water. The technology of liposomal microencapsulation, allows daily iron supplementation without any of the typical side effects of conventional oral iron supplements, such as heartburn, diarrhea, constipation, nausea and coloring of the mucous membranes and of the stools, which increases patient compliance. It has no metallic taste or smell, does not color mucous membrane and has excellent tolerability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Supplement | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Number of Participants Who Experienced an Adverse Event [ Designated as safety issue: Yes ] | upto 12 weeks |
| Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masood Jawaid, MRCS,FCPS | PharmEvo Pvt Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lubna Shahzad,Al-raheem surgical and Maternity Hospital, Daroghwala | Lahore | Sindh | Pakistan |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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|
To determine the efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels
| Week 12 |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |