NCT01414374

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

11 months

First QC Date

August 9, 2011

Last Update Submit

February 12, 2015

Conditions

Iron Deficiency Anemia

Keywords

ironanemiaherbal medicinephytotherapyCentella asiaticaHibiscus sabdariffa

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin

    Hemoglobin will be measured before treatment and after 6 weeks of treatment

    6 weeks

Study Arms (2)

Iron

ACTIVE COMPARATOR
Drug: Iron

Herbal

EXPERIMENTAL
Drug: Herbal medicine

Interventions

Herbal medicineDRUG

Patients will receive a combination of Hibiscus sabdariffa (powdered dry plant), 200 mg, BID, and Centella asiatica tincture, 40 drops, BID, for 6 weeks.

Herbal
IronDRUG

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

Iron

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \> 18 y and \< 50 y
  • A diagnostic of iron deficient anemia

You may not qualify if:

  • Severe anemia
  • Treatment interruption for more than 25% of the 6 weeks
  • New onset severe adverse symptoms or events
  • Patient's request

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorio M. F. Teixeira

Monte Santo de Minas, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemia

Interventions

PhytotherapyIron

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 11, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

BR(1)