A Clinical trial to determine the efficacy of capsule in iron deficiency anemia patients

Phase 4

Completed

• Conditions: Health Condition 1: D50- Iron deficiency anemia

• Registration Number: CTRI/2023/05/052772
• Lead Sponsor: Ambtu Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023
• Study Completion: 2023-11-28

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Male with moderate iron deficiency anemia (Hb 7.5 -8.0 gm%; S. Male Ferritin < 15 mcg / ml) with CKD under treatment by a Nephrologist.

2. Female with moderate iron deficiency anemia (Hb 7.5 -8.0 gm%; S. Ferritin < 15 mcg / ml) under treatment by a gynecologist.

3. Age between 18 and 60 years.

4. Willing to give informed consent.

Exclusion Criteria

1. Patient taking any iron supplement already at time of enrolment.

2. History of previous blood transfusion in the last 06 months.

3. Patient with Haemolytic anemia, Haemoglobinopathies, Myelodisplastic Syndromes and Neoplastic disorders.

4.Gastrointestinal surgeries that may impair iron absorption.

5. Patients with severe anemia (less than 6 gms%) requiring parenteral iron and / or blood transfusion.

6. Patients with cardiac, respiratory, neurological, gastro intestinal disease.

7. Female subjects demonstrating a positive pregnancy screen.

8. Patients diagnosed with severe gastritis, peptic ulcer, GI bleed or any other causes of pathological bleeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified