Aesculus Hippocastanum L. on Fontan Circulation

Effect of Aesculus Hippocastanum L. (Sapindaceae, "Horse Chestnut") on Fontan Circulation - a Randomized Clinical Trial

Sponsors

Lead Sponsor: Casa Espirita Terra de Ismael

Collaborator: Hospital das Clínicas de Ribeirão Preto

Source Casa Espirita Terra de Ismael
Brief Summary

Patients after the Fontan operation at a single institution will be randomized to receive a standardized extract of Aesculus hippocastanum L. (horse chestnut) or placebo for 4 months in a crossover clinical trial. The primary outcome will be the mesenteric artery resistance measured by Dopple sonography.

Overall Status Withdrawn
Start Date 2017-10-31
Completion Date 2020-12-31
Primary Completion Date 2020-12-31
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Mesenteric artery resistance After 4 months
Condition
Intervention

Intervention Type: Drug

Intervention Name: Aesculus Hippocastanum / Horse Chestnut

Description: Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.

Arm Group Label: Aesculus hippocastanum

Intervention Type: Drug

Intervention Name: Placebo

Description: Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria: - Underwent Fontan surgery Exclusion Criteria: - Severe adverse reaction - Personal or parental request

Gender:

All

Minimum Age:

2 Years

Maximum Age:

40 Years

Healthy Volunteers:

No

Location
Facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Location Countries

Brazil

Verification Date

2021-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Casa Espirita Terra de Ismael

Investigator Full Name: Fabio Carmona

Investigator Title: MD, PhD

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Aesculus hippocastanum

Type: Experimental

Description: Patients will receive extract of Aesculus hippocastanum

Label: Placebo

Type: Placebo Comparator

Description: Patients will receive placebo

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Patients will be randomized to receive Aesculus hippocastanum or placebo for 4 months, followed by 4 weeks of washout and crossover.

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: The capsules will be identical in appearance and will be labelled only with patient's name.

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