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

February 12, 2015 updated by: Fabio Carmona, Casa Espirita Terra de Ismael

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Monte Santo de Minas, Minas Gerais, Brazil
        • Laboratorio M. F. Teixeira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: 6 weeks
Hemoglobin will be measured before treatment and after 6 weeks of treatment
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa Espirita Terra de Ismael

Collaborators

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANEMIA2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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