Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers

NCT ID: NCT04051476

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2020-01-31

Brief Summary

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A study to explore whether different dosages of ginger flour in footbaths cause different effects on warmth development as well as on general well-being and the autonomic nervous system.

Detailed Description

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This is a four-arm randomized controlled trial with crossover design to explore the dose-response relationship of footbaths with different dosages of ginger flour in healthy volunteers, compared to a placebo control (footbath with warm water only). The main focus is on thermogenesis and warmth distribution, as assessed by high-resolution infrared thermography and questionnaire data before, during and after the intervention. In addition, effects on the autonomic nervous system are assessed by measuring various parameters of heart rate variability and pulse wave analysis.

Conditions

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Thermogenesis by Different-dosage Ginger Flour Footbaths

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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3-g footbath

Footbath with 3g ginger flour per liter of water

Group Type EXPERIMENTAL

3-g footbath

Intervention Type OTHER

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g ginger flour (3 g per l), followed by a ten-minute post-intervention rest period.

6-g footbath

Footbath with 6g ginger flour per liter of water

Group Type EXPERIMENTAL

6-g footbath

Intervention Type OTHER

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g ginger flour (6 g per l), followed by a ten-minute post-intervention rest period.

12-g footbath

Footbath with 12g ginger flour per liter of water

Group Type EXPERIMENTAL

12-g footbath

Intervention Type OTHER

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g ginger flour (12 g per l), followed by a ten-minute post-intervention rest period.

Warm water footbath

Footbath with warm water only

Group Type PLACEBO_COMPARATOR

Warm water footbath

Intervention Type OTHER

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C), followed by a ten-minute post-intervention rest period.

Interventions

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3-g footbath

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g ginger flour (3 g per l), followed by a ten-minute post-intervention rest period.

Intervention Type OTHER

6-g footbath

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g ginger flour (6 g per l), followed by a ten-minute post-intervention rest period.

Intervention Type OTHER

12-g footbath

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g ginger flour (12 g per l), followed by a ten-minute post-intervention rest period.

Intervention Type OTHER

Warm water footbath

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C), followed by a ten-minute post-intervention rest period.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Age between 18 and 55 years

Exclusion Criteria

* Chronic skin lesions at the lower legs or feet
* Known intolerance or hypersensitivity to ginger preparations
* Cardiac arrhythmia
* Cardiac pacemaker
* Asthma bronchiale
* Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
* Pregnancy
* Insufficient knowledge of the german language
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Vagedes, Dr.

Role: PRINCIPAL_INVESTIGATOR

Arcim Institute

Locations

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Arcim Institute

Filderstadt, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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SWI_08

Identifier Type: -

Identifier Source: org_study_id

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