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

Iron Deficiency Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414374
• Other study ID #: ANEMIA2011
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2011
• Last updated: February 12, 2015
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2015
• Source: Casa Espirita Terra de Ismael
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

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.
• Iron
Patients will receive iron sulphate, 500 mg, BID, plus orange juice, for 6 weeks.

Locations

Country	Name	City	State
Brazil	Laboratorio M. F. Teixeira	Monte Santo de Minas	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Casa Espirita Terra de Ismael	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	Hemoglobin will be measured before treatment and after 6 weeks of treatment	6 weeks	No