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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01414374
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : February 13, 2015
University of Sao Paulo
Information provided by (Responsible Party):
Fabio Carmona, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Herbal medicine Drug: Iron Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Active Comparator: Iron Drug: Iron
Patients will receive iron sulphate, 500 mg, BID, plus orange juice, for 6 weeks.

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

Primary Outcome Measures :
  1. Hemoglobin [ Time Frame: 6 weeks ]
    Hemoglobin will be measured before treatment and after 6 weeks of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01414374

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Laboratorio M. F. Teixeira
Monte Santo de Minas, Minas Gerais, Brazil
Sponsors and Collaborators
Casa Espirita Terra de Ismael
University of Sao Paulo

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Responsible Party: Fabio Carmona, Assistant Professor, University of Sao Paulo Identifier: NCT01414374     History of Changes
Other Study ID Numbers: ANEMIA2011
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015

Keywords provided by Fabio Carmona, University of Sao Paulo:
herbal medicine
Centella asiatica
Hibiscus sabdariffa

Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs