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

This study has been completed.
University of Sao Paulo
Information provided by (Responsible Party):
Fabio Carmona, University of Sao Paulo
ClinicalTrials.gov Identifier:
First received: August 9, 2011
Last updated: February 12, 2015
Last verified: February 2015
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Casa Espirita Terra de Ismael:

Primary Outcome Measures:
  • Hemoglobin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01414374

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

No publications provided

Responsible Party: Fabio Carmona, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01414374     History of Changes
Other Study ID Numbers: ANEMIA2011
Study First Received: August 9, 2011
Last Updated: February 12, 2015
Health Authority: Brazil: Ethics Committee

Keywords provided by Casa Espirita Terra de Ismael:
herbal medicine
Centella asiatica
Hibiscus sabdariffa

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

ClinicalTrials.gov processed this record on November 24, 2015