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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Casa Espirita Terra de Ismael.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by:
Casa Espirita Terra de Ismael
ClinicalTrials.gov Identifier:
NCT01414374
First received: August 9, 2011
Last updated: August 10, 2011
Last verified: August 2011
  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
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


Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: March 2013
Estimated 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

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

Contacts
Contact: Vinicius Teixeira viniciusteixeira.26@gmail.com

Locations
Brazil
Laboratorio M. F. Teixeira Not yet recruiting
Monte Santo de Minas, Minas Gerais, Brazil
Contact: Vinicius Teixeira         
Sponsors and Collaborators
Casa Espirita Terra de Ismael
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Ana Maria Soares Pereira, UNAERP
ClinicalTrials.gov Identifier: NCT01414374     History of Changes
Other Study ID Numbers: ANEMIA2011
Study First Received: August 9, 2011
Last Updated: August 10, 2011
Health Authority: Brazil: Comissao Nacional de Etica em Pesquisa (CONEP)

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

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

ClinicalTrials.gov processed this record on April 16, 2014