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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414374
First Posted: August 11, 2011
Last Update Posted: February 13, 2015
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.
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Fabio Carmona, University of Sao Paulo
  Purpose
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 Intervention Phase
Iron Deficiency Anemia Drug: Herbal medicine Drug: Iron Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fabio Carmona, University of Sao Paulo:

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


Enrollment: 50
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01414374


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

Responsible Party: Fabio Carmona, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01414374     History of Changes
Other Study ID Numbers: ANEMIA2011
First Submitted: August 9, 2011
First Posted: August 11, 2011
Last Update Posted: February 13, 2015
Last Verified: February 2015

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

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


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