A clinical study to evaluate Micellar Iron for treatment of Iron Deficiency Anaemia

Phase 4

• Conditions: Health Condition 1: D509- Iron deficiency anemia, unspecified

• Registration Number: CTRI/2020/12/029778
• Lead Sponsor: Amitojas Wellness Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female subjects aged 18 years and above.

2. Male subjects with haemoglobin level below 13.0 g/dL and female subjects with haemoglobin level below 12.0 g/dL.

3. Subjects willing to provide informed written consent.

Exclusion Criteria

1. Pregnant, planning to become pregnant or breastfeeding women.

2. Subjects with anaemia other than iron deficiency anaemia.

3. Subjects have undergone blood transfusion or underwent iron therapy in the last three months.

4. Subjects with microcytic iron-overloading disorder (thalassemia, sideroblastic anemia)

5. Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months.

6. Alcohol or substance abuse

7. Allergy or sensitivity to any of the ingredients in the study treatment

8. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly

9. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum Ferritin levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline and day 30

Secondary Outcome Measures

Name	Time	Method
Haemoglobin levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline and day 30