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Completed

NCT Number: NCT01414374

Hibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency

The study aims to investigate the prevalence of genetic polymorphisms in adults with iron deficiency and anemia, and the responses to two different treatments: iron sulphate and a composite herbal medicine (Hibiscus sabdariffa plus Centella asiatica). The main outcome will be hemoglobin, measured before and after 6 weeks.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laboratorio M. F. Teixeira

Monte Santo de Minas, Minas Gerais, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 y and < 50 y
  • A diagnostic of iron deficient anemia

Exclusion criteria

  • Severe anemia
  • Treatment interruption for more than 25% of the 6 weeks
  • New onset severe adverse symptoms or events
  • Patient's request

Treatment and study plan

Herbal medicine

Drug

Patients will receive a combination of Hibiscus sabdariffa (powdered dry plant), 200 mg, BID, and Centella asiatica tincture, 40 drops, BID, for 6 weeks.

Iron

Drug

Patients will receive iron sulphate, 500 mg, BID, plus orange juice, for 6 weeks.

Primary outcomes

  1. Hemoglobin

    Time frame: 6 weeks

    Hemoglobin will be measured before treatment and after 6 weeks of treatment

Sponsors and collaborators

Lead sponsor

Casa Espirita Terra de Ismael

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

Prevalence of Genetic Polymorphisms of DMT1 and Ferroportin Enzymes in Adults With Anemia by Iron Deficiency, and Its Influence on the Efficacy of Conventional and Herbal Treatments

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Aug 11, 2011
Registry last updated
Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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