A comparative clinical study to evaluate a product in Iron Deficiency Subjects

Not Applicable

• Conditions: Health Condition 1: E611- Iron deficiency

• Registration Number: CTRI/2023/06/053923
• Lead Sponsor: Akay Natural Ingredients Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

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

Inclusion Criteria

1 Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study

2 Subjects with low serum ferritin level(â?¹30mg/L)

3 Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening

Exclusion Criteria

1.Subjects with severe Iron deficiency anemia

2.Subjects who are pregnant or lactating

3.Subjects with raised inflammatory markers (CRP >1 mg/l or ESR >20 mm/1st hour).

4.Subjects having specific symptoms attributable to upper gastro-intestinal (GI) tract disease.

5.Patients who had major surgery or invasive intervention within 4 weeks prior to screening, or intervention planned during the course of the study.

6.Subjects having history of

•Uncontrolled hypertension

•Coronary artery disease, Angina, tread mill test (TMT) positive for inducible ischemia

•Psychiatric illness

•Drug abuse, smoking, abuse/addiction to alcohol

•Endocrine abnormalities including stable thyroid disease

•Cardiovascular surgery

Patients with hemochromatosis or other iron storage disorders.

7.Subjects currently or have history of smoking more than 10 cigarettes per day

8.Donation or loss of blood or plasma: 50 mL or more within 60 days prior to the administration of study medication

9.Subjects who maybe allergic to any of the natural constituents of the Investigational Product.

10.Subjects with history of severe Covid-19.

11.Known HIV or Hepatitis B positive or any other immuno-compromised state

12.Subjects on any other medical or clinical investigation or on any nutrition supplements and dietary regime.

Study & Design

• Study Type: Interventional
• Study Design: Not specified