CTRI/2023/06/053923Not yet recruitingUnknown
A Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Comparative Evaluation of HIA-10-23 in Iron Deficient Population.
Akay Natural Ingredients Pvt. Ltd.0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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.
Investigators
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