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

Sponsor

Casa Espirita Terra de Ismael (Other)

Overall Status

Completed

CT.gov ID

NCT01414374

Collaborator

University of Sao Paulo (Other)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia	Drug: Herbal medicine Drug: Iron	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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.

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.