Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep

NCT04210895 | Completed

• 1 other identifier: INS_01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, controlled trial to explore whether warm footbaths with added ginger powder can improve the sleep quality of adults with self-perceived insomnia symptoms. Participants receive daily footbaths either with warm water alone or with added ginger powder over a period of 2 weeks.

Conditions

Nonorganic Insomnia

Outcome Measures

Primary Outcomes (1)

• Change in global PSQI Score

  Global score of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 21=negative extreme

  Baseline (pre intervention), 2 weeks after baseline (post intervention)

Secondary Outcomes (27)

• Change in subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

  Baseline (pre intervention), 2 weeks after baseline (post intervention)

• Change in sleep latency as assessed by the PSQI

  Baseline (pre intervention), 2 weeks after baseline (post intervention)

• Change in sleep duration as assessed by the PSQI

  Baseline (pre intervention), 2 weeks after baseline (post intervention)

• Change in sleep efficiency as assessed by the PSQI

  Baseline (pre intervention), 2 weeks after baseline (post intervention)

• Change in sleep disturbance as assessed by the PSQI

  Baseline (pre intervention), 2 weeks after baseline (post intervention)

Study Arms (2)

Warm footbath with ginger powder

EXPERIMENTAL

Participants receive a daily warm water footbath with added ginger powder over a two-week period

Other: Ginger powder footbath

Warm water only footbath

ACTIVE COMPARATOR

Participants receive a daily warm water footbath over a two-week period

Other: Warm water only footbath

Interventions

Ginger powder footbath OTHER

40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level

Warm footbath with ginger powder

Warm water only footbath OTHER

40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level

Warm water only footbath

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• age between 18 and 70 years
• self-reported insomnia symptoms

You may not qualify if:

• known organic insomnia (e.g. periodic leg movements during sleep, restless legs syndrome, sleep apnea syndrome, narcolepsy)
• current intake of allopathic hypnotics
• shift work
• skin lesions at the lower legs or feet
• known intolerance or hypersensitivity to ginger preparations
• acute mental disorder
• varicose vein (degree 3 or 4, classification according to Marshall), chronic venous insufficiency
• pregnancy
• participation in other studies
• insufficient knowledge of the german language

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jan Vagedes, MD

  ARCIM Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 26, 2019
• Study Start: January 7, 2020
• Primary Completion: April 11, 2020
• Study Completion: April 11, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available upon publication for a duration of three months.
• Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

Locations

DE (1)