Hibiscus Sabdariffa and Centella Asiatica in the Treatmen... | NCT01414374

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

NCT01414374

Sponsor

Casa Espirita Terra de Ismael

Status

Completed

Last Update Posted

Feb 13, 2015Estimated

Enrollment

50Actual

Phase

Phase 3

Conditions

Iron Deficiency Anemia

Interventions

Herbal medicine
Iron

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Mar 2013Actual

First Submitted Date

Aug 9, 2011

First Submission Date that Met QC Criteria

Aug 10, 2011

First Posted Date

Aug 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2015

Last Update Posted Date

Feb 13, 2015Estimated

Name	Class
University of Sao Paulo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iron	Active Comparator		Drug: Iron
Herbal	Experimental		Drug: Herbal medicine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Herbal medicine	Drug	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratorio M. F. Teixeira		Monte Santo de Minas	Minas Gerais		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency
D000740	Anemia

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000090463	Iron Deficiencies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008517	Phytotherapy
D007501	Iron

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D019216	Metals, Heavy
D004602	Elements

Browse Leaves

Not provided

Browse Branches

Not provided