Back to resultsHibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Herbal medicine
Iron
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring iron, anemia, herbal medicine, phytotherapy, Centella asiatica, Hibiscus sabdariffa
Eligibility 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
Sites / Locations
- Laboratorio M. F. Teixeira
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Iron
Herbal
Arm Description
Outcomes
Primary Outcome Measures
Hemoglobin
Hemoglobin will be measured before treatment and after 6 weeks of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT01414374
First Posted
August 9, 2011
Last Updated
February 12, 2015
Sponsor
Casa Espirita Terra de Ismael
Collaborators
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01414374
Brief Title
Hibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Casa Espirita Terra de Ismael
Collaborators
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
iron, anemia, herbal medicine, phytotherapy, Centella asiatica, Hibiscus sabdariffa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iron
Arm Type
Active Comparator
Arm Title
Herbal
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Herbal medicine
Intervention Description
Patients will receive a combination of Hibiscus sabdariffa (powdered dry plant), 200 mg, BID, and Centella asiatica tincture, 40 drops, BID, for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Iron
Intervention Description
Patients will receive iron sulphate, 500 mg, BID, plus orange juice, for 6 weeks.
Primary Outcome Measure Information:
Title
Hemoglobin
Description
Hemoglobin will be measured before treatment and after 6 weeks of treatment
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Laboratorio M. F. Teixeira
City
Monte Santo de Minas
State/Province
Minas Gerais
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Hibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency
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