Nonorganic InsomniaNCT04210895
Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep
A study testing Ginger powder footbath and Warm water only footbath in people with Nonorganic Insomnia, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonorganic Insomnia
- What is being tested?
- Ginger powder footbath and Warm water only footbath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jan 2020to 11 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- age between 18 and 70 years
- self-reported insomnia symptoms
Who cannot join
- 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
Show all 10Show fewer
- varicose vein (degree 3 or 4, classification according to Marshall), chronic venous insufficiency
- pregnancy
- participation in other studies
- insufficient knowledge of the german language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep: a Randomized Controlled Pilot Study
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.
Read the detailed description
This is a randomized controlled trial with parallel group design to explore the effects of warm water footbaths with added ginger powder (experimental) compared to footbaths with warm water alone (active comparator) on sleep quality in adults with self-perceived insomnia symptoms. Participants receive daily footbaths 1-3 hours before bedtime over a period of two weeks. The footbaths are prepared by the participants themselves and carried out at their homes. Outcome measures are assessed at baseline (pre intervention) and two weeks after baseline (post intervention). The main focus is on change in subjective quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI). The statistical analysis comprises analyses of variance based on linear mixed effects models.
- Conditions
- Nonorganic Insomnia
- Being tested
- Ginger powder footbath, Warm water only footbath
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger powder footbathOther
40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level
Warm water only footbathOther
40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level
| Study group | Role | What they receive |
|---|---|---|
| Warm footbath with ginger powder | Experimental | Participants receive a daily warm water footbath with added ginger powder over a two-week period Receives: Other: Ginger powder footbath |
| Warm water only footbath | Active comparator | Participants receive a daily warm water footbath over a two-week period Receives: Other: Warm water only footbath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global PSQI Score
Global score of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 21=negative extreme
Measured: 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)
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep latency as assessed by the PSQI
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep duration as assessed by the PSQI
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep efficiency as assessed by the PSQI
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep disturbance as assessed by the PSQI
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in use of sleep medication as assessed by the PSQI
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in daytime dysfunction as assessed by the PSQI
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in the Insomnia Severity Index total score
Total score of the Insomnia Severity Index, score between 0=no clinically significant insomnia and 28=severe clinical insomnia
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Evening protocol: Change in general well-being as assessed by a standardized sleep diary
Self-reported well-being measured with a standardized sleep diary (six-point rating scale, higher values represent a better outcome)
Measured: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Evening protocol: Change in the average performance as assessed by a standardized sleep diary
Self-reported performance measured with a standardized sleep diary (six-point rating scale, lower values represent a better outcome)
Measured: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Evening protocol: Change in fatigue as assessed by a standardized sleep diary
Self-reported fatigue measured with a standardized sleep diary (four-point rating scale, lower values represent a better outcome)
Measured: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Evening protocol: Change in sleep during daytime as assessed by a standardized sleep diary
Self-reported sleep during daytime measured with a standardized sleep diary (specification in minutes, lower values represent a better outcome)
Measured: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in recovery ability as assessed by a standardized sleep diary
Self-reported recovery ability measured with a standardized sleep diary (five-point rating scale, lower values represent a better outcome)
Measured: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in general well-being as assessed by a standardized sleep diary
Self-reported well-being measured with a standardized sleep diary (six-point rating scale, higher values represent a better outcome)
Measured: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in sleep latency as assessed by a standardized sleep diary
Self-reported sleep latency measured with a standardized sleep diary (specification in minutes, lower values represent a better outcome)
Measured: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in nocturnal awakening as assessed by a standardized sleep diary
Self-reported nocturnal awakening measured with a standardized sleep diary (specification in minutes, lower values represent a better outcome)
Measured: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in sleep duration as assessed by a standardized sleep diary
Self-reported sleep duration measured with a standardized sleep diary (specification in hours, higher values represent a better outcome)
Measured: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Change in quality of life as assessed by the 12-Item Short Form Survey
Scales of the 12-Item Short Form Survey (SF-12), scores between 0=more dysfunction/impairment and 100=less dysfunction/impairment
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in subjective feeling of overall warmth as assessed by the Herdecke Warmth Perception Questionnaire
Self-reported feeling of overall warmth and warmth at the face, trunk anterior/posterior, hands and feet measured with the Herdecke Warmth Perception Questionnaire, scores between 0=cold and 4=hot
Measured: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in RMSSD
Root mean square of successive differences (RMSSD) [ms]. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Measured: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in SDNN
Standard deviation of normal to normal (NN) intervals (SDNN) [ms]. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Measured: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in pNN50
The proportion of NN50 (number of pairs of successive NNs that differ by more than 50 ms) divided by total number of NNs (pNN50). HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Measured: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in VLF
Very low frequency (VLF, 0.0033 to 0.04 Hz) from frequency domain analysis. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Measured: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in LF
Low frequency (LF, 0.04 to 0.15 Hz) from frequency domain analysis. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Measured: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in HF
High frequency (HF, 0.15 to 0.40 Hz) from frequency domain analysis. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Measured: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in LF/HF ratio
Ratio of two bands from frequency domain analysis: LF band (0.04 to 0.15 Hz) and HF band (0.15 to 0.40 Hz). HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Measured: Baseline (pre intervention) and two weeks after baseline (post intervention)
Change in distal-proximal skin-temperature gradient
24-hour measurement of the skin temperature at the feet and abdomen with "MAXIM I-Button™ DS1922L" (Maxim integrated, San Jose, USA). The gradient is calculated by subtracting the proximal value from the distal value.
Measured: Baseline (pre intervention) and two weeks after baseline (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start7 Jan 2020
- Primary completion11 Apr 2020
- Study completion11 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonorganic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, MD, Study director, ARCIM Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210895
- Sponsor's protocol ID
- INS_01
- Status last verified
- Apr 2020
- First submitted
- 18 Dec 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04210895
- Acronym / sponsor ID
- INS_01
- Conditions
- Nonorganic Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 11 Apr 2020 (actual)
- Study completion
- 11 Apr 2020 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized controlled trial with parallel group design to explore the effects of warm water footbaths with added ginger powder (experimental) compared to footbaths with warm water alone (active comparator) on sleep quality in adults with self-perceived insomnia symptoms. Participants receive daily footbaths 1-3 hours before bedtime over a period of two weeks. The footbaths are prepared by the participants themselves and carried out at their homes. Outcome measures are assessed at baseline (pre intervention) and two weeks after baseline (post intervention). The main focus is on change in subjective quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI). The statistical analysis comprises analyses of variance based on linear mixed effects models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm footbath with ginger powder | Experimental | Other: Ginger powder footbathParticipants receive a daily warm water footbath with added ginger powder over a two-week period |
| Warm water only footbath | Active comparator | Other: Warm water only footbathParticipants receive a daily warm water footbath over a two-week period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent
- age between 18 and 70 years
- self-reported insomnia symptoms
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger powder footbath40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level | Other | Warm footbath with ginger powder |
| Warm water only footbath40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level | Other | Warm water only footbath |
Primary outcome
Change in global PSQI Score
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Global score of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 21=negative extreme
27 secondary outcomes
Change in subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep latency as assessed by the PSQI
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep duration as assessed by the PSQI
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep efficiency as assessed by the PSQI
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep disturbance as assessed by the PSQI
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in use of sleep medication as assessed by the PSQI
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in daytime dysfunction as assessed by the PSQI
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in the Insomnia Severity Index total score
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Evening protocol: Change in general well-being as assessed by a standardized sleep diary
Time frame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Evening protocol: Change in the average performance as assessed by a standardized sleep diary
Time frame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Evening protocol: Change in fatigue as assessed by a standardized sleep diary
Time frame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Evening protocol: Change in sleep during daytime as assessed by a standardized sleep diary
Time frame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in recovery ability as assessed by a standardized sleep diary
Time frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in general well-being as assessed by a standardized sleep diary
Time frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in sleep latency as assessed by a standardized sleep diary
Time frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in nocturnal awakening as assessed by a standardized sleep diary
Time frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in sleep duration as assessed by a standardized sleep diary
Time frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Change in quality of life as assessed by the 12-Item Short Form Survey
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in subjective feeling of overall warmth as assessed by the Herdecke Warmth Perception Questionnaire
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in RMSSD
Time frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in SDNN
Time frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in pNN50
Time frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in VLF
Time frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in LF
Time frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in HF
Time frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in LF/HF ratio
Time frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Change in distal-proximal skin-temperature gradient
Time frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, MD study director
ARCIM Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginger powder footbath and Warm water only footbath in people with Nonorganic Insomnia, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global PSQI Score (time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.