Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water Footbaths

July 20, 2020 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Efficacy of Foot Baths With and Without Ginger Powder Additive on the Subjective Feeling of Warmth and on Body Core Temperature of Adolescents With Anorexia Nervosa - a Randomized, Controlled Pilot Study

A study to explore whether warm water footbaths with added ginger powder can improve thermoregulatory processes in adolescent anorexia nervosa patients and provide them with an increase in subjective feeling of warmth. The participants will receive a warm footbath four times a week for six weeks with a physiological and psychological testing point once before the beginning of the six-week footbath period and once after.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a two-arm randomized controlled trial to evaluate the efficacy of warm water footbaths with added ginger powder (experimental) compared to warm water only footbaths (control) in adolescent anorexia nervosa patients. Participants will receive footbaths 4 times per week before bed-time over a period of six weeks.The main focus is on subjective increase in overall body warmth. Moreover, core body temperature, skin temperature at the extremities and several psychological as well as physiological scores and parameters are assessed before and after the six-week intervention. A follow-up is planned at six months post intervention, where core body temperature, physiological and psychological parameters are once more tested.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden Württemberg
      • Filderstadt, Baden Württemberg, Germany, 70794
        • ARCIM Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • main diagnosis: Anorexia nervosa
  • written informed consent of participants and legal guardians

Exclusion Criteria:

  • other eating disorder diagnosis apart from Anorexia nervosa
  • known allergic reaction to ginger

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Warm water with ginger powder footbath
Participants who receive a warm water with added ginger powder footbath four times a week over a six-week period.
Other: ginger powder footbath
38-40° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level, as practiced in anthroposophic medicine
ACTIVE_COMPARATOR: Warm water only footbath
Participants who receive a warm water only footbath four times a week over a six-week period.
Other: warm water only footbath
38-40° C warm water footbath without any additive reaching up to mid-calf level

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Chnge in Subjective feeling of overall warmth
Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention)
Self-reported feeling of overall warmth measured using the HeWEF 1.2 (Herdecker Wärmeempfindungs-Fragebogen) overall warmth perception questionnaire
Baseline (pre intervention), 6 weeks after baseline (post intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Core body temperature
Time Frame: Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up
Core body temperature measured using an infrared tympanical thermometer as used in clinical routine
Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up
Face surface temperature
Time Frame: Baseline (pre intervention) and 6 weeks after baseline (post intervention)
Surface temperature in the face measured using high-resolution infrared thermography
Baseline (pre intervention) and 6 weeks after baseline (post intervention)
Feet surface temperature
Time Frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Surface temperature at the feet measured using high-resolution infrared thermography
Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Hand surface temperature
Time Frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Surface temperature on the hands measured using high-resolution infrared thermography
Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Abdomen surface temperature
Time Frame: Baseline (pre intervention) and after 6 weeks (post intervention)
Surface temperature at the abdomen measured using high-resolution infrared thermography
Baseline (pre intervention) and after 6 weeks (post intervention)
24-hour feet surface temperature
Time Frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention)
24 hour surface temperature at the feet measured using a surface data-logger (i-Button TM)
Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention)
24-hour hand surface temperature
Time Frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24 hour surface temperature on the hands measured using a surface data-logger (i-Button TM)
Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24-hour abdomen surface temperature
Time Frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24 hour surface temperature at the abdomen measured using a surface data-logger (i-Button TM)
Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24-hour torso surface temperature
Time Frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24 hour surface temperature at the upper torso measured using a surface data-logger (i-Button TM)
Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
Body Mass Index
Time Frame: Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up
Body Mass Index (BMI) Calculated as (Weight in Kg)/〖(Height in m)^2〗
Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up
Pulse Transit Time (PTT)
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
PTT in ms, measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Perfusion Index (PI)
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
PI, measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Peak to Peak Time (PPT)
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
SlopeInW1
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention)
SlopeInW2
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW3
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW4
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Stiffness Index
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Reflection Index
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTX
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTX in ms (millisecond), measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTY
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTY in ms, measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTYTX
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAX
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
AreaAY
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAYAX
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAV
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAW
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAWAV
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTVTW
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTV
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTV in ms, measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTW
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTW in ms, measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MinT1
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MinT2
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
MaxT1
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the first peak
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MaxT2
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the second peak
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotHRRespRate
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Heart rate
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
beats per minute (bpm) measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Respiratory rate
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
SDNN (standard deviation of normal to normal)
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Standard deviation of normal to normal beats, measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
RMSSD (Root mean square of successive differences)
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Root mean square of successive differences, measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
pNN50
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Number of pairs of successive heart rate intervals that differ by more than 50 ms
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
HF (high frequency)
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Area under the curve between the frequency of 0.15 to 0.4Hz measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
LF (low frequency)
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Area under the curve between the frequency of 0.04 to 0.15Hz measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
LF/HF-Ratio
Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz), measured with the GeTeMed Vitaguard 3100
Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Pittsburgh sleep quality index
Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Scores of the PSQI (Pittsburgh sleep quality index)
Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Eating Disorder Inventory -2
Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Scores of the EDI-2 (Eating Disorder Inventory)
Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Eating Disorder Examination- Questionnaire
Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Scores of the EDE-Q (Eating Disorder Examination)
Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Becks Depressions Inventar
Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Scores of the BDI-II (Becks Depression Inventar)
Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Hospital Anxiety and Depression Scale subscale Anxiety
Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Anxiety Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)
Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Hospital Anxiety and Depression Scale subscale Depression
Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Depression Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)
Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Body Image State Scale
Time Frame: Baseline (pre intervention),6 weeks after baseline (post intervention), at six-month follow-up
Mean of all six item values (range from 0-9) with higher values indicating a positive body image state of the BISS (Body Image State Scale)
Baseline (pre intervention),6 weeks after baseline (post intervention), at six-month follow-up
Positive And Negative Affect Schedule
Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Scores of the PANAS-X (Positive and negative affect schedule)
Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Short Form Health Survey 12
Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Scores of the SF-12 (Short Form 12)
Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Basler Befindlichkeits Skala
Time Frame: Baseline (pre intervention), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up
Scores of the BBS (Basler Befindlichkeits Skala =basler mood questionnaire)
Baseline (pre intervention), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up
Body Shape Questionnaire
Time Frame: Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up
Scores of the BSQ (Body Shape Questionnaire)
Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Filderklinik, Filderstadt, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan Vagedes, Dr. med., ARCIM Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANS_03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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