Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Status: Completed

Conditions: Thermogenesis by Different-dosage Ginger Flour Footbaths

Treatments: Other: Warm water footbath; Other: 12-g footbath; Other: 3-g footbath; Other: 6-g footbath

Study type: Interventional

Funder types: Other

Identifiers

NCT04051476

SWI_08

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 4 patient groups, including a placebo group

3-g footbath

Experimental group

Description:

Footbath with 3g ginger flour per liter of water

Treatment:

Other: 3-g footbath

6-g footbath

Experimental group

Description:

Footbath with 6g ginger flour per liter of water

Treatment:

Other: 6-g footbath

12-g footbath

Experimental group

Description:

Footbath with 12g ginger flour per liter of water

Treatment:

Other: 12-g footbath

Warm water footbath

Placebo Comparator group

Description:

Footbath with warm water only

Treatment:

Other: Warm water footbath