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

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ClinicalTrials.gov Identifier: NCT01414374
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : February 13, 2015
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Fabio Carmona, University of Sao Paulo

August 9, 2011
August 11, 2011
February 13, 2015
January 2012
December 2012   (Final data collection date for primary outcome measure)
Hemoglobin [ Time Frame: 6 weeks ]
Hemoglobin will be measured before treatment and after 6 weeks of treatment
Same as current
Complete list of historical versions of study NCT01414374 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Hibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Iron Deficiency Anemia
  • 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.
  • Drug: Iron
    Patients will receive iron sulphate, 500 mg, BID, plus orange juice, for 6 weeks.
  • Active Comparator: Iron
    Intervention: Drug: Iron
  • Experimental: Herbal
    Intervention: Drug: Herbal medicine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
400
March 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01414374
ANEMIA2011
No
Not Provided
Not Provided
Fabio Carmona, University of Sao Paulo
Casa Espirita Terra de Ismael
University of Sao Paulo
Not Provided
Casa Espirita Terra de Ismael
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP