Primary DysmenorrheaNCT04071028
Heart Rate Variability as an Indicator Associated With the Improvement of Dysmenorrhea After the Warm-water Footbath
A study testing warm-water footbath in people with Primary Dysmenorrhea, run by Camillians Saint Mary's Hospital Luodong.
Trial summary
The effect of warm-water footbath in improving primary dysmenorrhea (PD) was rarely investigated previously. We aimed to exam the hypothesis that warm-water footbath is effective to reduce the pain of PD, and the effect is associated with changes in the autonomic nervous system (ANS) activity. Read more about this study
- Who is it for?
- Ages 16 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- warm-water footbath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2013to 30 Jun 2014
- 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 16 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy female students aged 16-20 years of the nursing college;
- had regular menstrual cycles;
- experienced dysmenorrhea within 6 months before the enrollment;
- had dysmenorrhea with severity higher than five scores of the pain visual analog scale (PVAS); and
- had no experience of pregnancy.
Who cannot join
- had irregular menstrual cycles;
- had circulation problem of legs such as peripheral arterial occlusive disease or deep vein thrombosis;
- had wounds or skin lesions over legs; and
- had taken any medications which affect ANS activity.
About this study
The effect of warm-water footbath in improving primary dysmenorrhea (PD) was rarely investigated previously. We aimed to exam the hypothesis that warm-water footbath is effective to reduce the pain of PD, and the effect is associated with changes in the autonomic nervous system (ANS) activity.
The quasi-experimental study was carried out enrolling 68 college students) with PD. The enrolled participants were randomized into two groups and received interventions (footbath (n=35) versus sitting only (n=33)) for 20 minutes per day on their menstruation days 1 and 2.
After the interventions, we analyzed the association among intervention (with footbath versus without footbath), heart rate variability (HRV) changes and changes of pain scales (Pain Visual Analog Scale and short-form McGill Pain Questionnaire).
Read the detailed description
Dysmenorrhea is the most common gynecological condition affecting 16% to 95% of adolescents and young women, and reduce their quality of life. Primary dysmenorrhea (PD), a term denoting the dysmenorrhea in the absence of underlying pathology, is commonly referred to as period pain or menstrual cramps by the lay press and public.
The effect of warm-water footbath in improving primary dysmenorrhea (PD) was rarely investigated previously. We aimed to exam the hypothesis that warm-water footbath is effective to reduce the pain of PD, and the effect is associated with changes in the autonomic nervous system (ANS) activity.
This study was approved by the Institutional Review Board of Saint Mary Hospital Luodong (SMHIRB102015).
This study with a quasi-experimental design was conducted in a nursing college in Northern Taiwan during the study period from December 1, 2013, to June 30, 2014. Participants were eligible for enrollment if they: (1) were healthy female students aged 16-20 years of the nursing college; (2) had regular menstrual cycles; (3) experienced dysmenorrhea within 6 months before the enrollment; (4) had dysmenorrhea with severity higher than five scores of the pain visual analog scale (PVAS); and (5) had no experience of pregnancy. The exclusion criteria included individuals whom: (1) had irregular menstrual cycles; (2) had circulation problem of legs such as peripheral arterial occlusive disease or deep vein thrombosis; (3) had wounds or skin lesions over legs; and (4) had taken any medications which affect ANS activity. The suggested participant's number estimated by the G-Power was 34 when setting the calculated power as 0.8 and α as 0.05. Considering participant loss during the study process, we decided to enroll 68 participants.
All enrolled participants were randomized into the footbath group (n=35) and control group (n=33). The baseline demographic data, as well as relevant information about menstrual cycles and dysmenorrhea of all participants, were documented at enrollment. All the participants were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, the participants in the "footbath group" received legs soaking from the heel to the Sanyinjiao (SP6) acupoint (above the ankle) 24 in 42 ℃ water with air bubbles and vibration given to the soles for 20 minutes, whereas the participants in the "control group" kept on sitting quietly without legs soaking during the additional 20-minute period.
PVAS and Short-Form McGill Pain Questionnaire (SF-MPQ) were fulfilled as pain assessment by all participants twice, including a "pre-test" before the intervention of menstruation day 1 and a "post-test" after the intervention of menstruation day 2.
HRV was measured at four time points (before and immediately after the interventions on days 1 and 2) to assess ANS function for all participants.
The interventions were "warm-water footbath for 20 minutes" for the "footbath group" and "sitting quietly without footbath for 20 minutes" for the "control group." Then we evaluated the influence of warm-water footbath on dysmenorrhea and several variables, including HRV indices and stiffness index.
- Conditions
- Primary Dysmenorrhea
- Being tested
- warm-water footbath
- Keywords
- footbath, parasympathetic activity, primary dysmenorrhea, sympathetic activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warm-water footbathProcedure or surgery
All the participants in the intervention group were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, the participants in the "footbath group" received legs soaking from the heel to the Sanyinjiao (SP6) acupoint (above the ankle) 24 in 42 ℃ water with air bubbles and vibration given to the soles for 20 minutes, whereas the participants in the "control group" kept on sitting quietly without legs soaking during the additional 20-minute period.
| Study group | Role | What they receive |
|---|---|---|
| Footbath group | Active comparator | All the participants were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, the participants in the "footbath group" received legs soaking from the heel to the Sanyinjiao (SP6) acupoint (above the ankle) 24 in 42 ℃ water with air bubbles and vibration given to the soles for 20 minutes, Receives: Procedure: warm-water footbath |
| Control group | No intervention | All the participants were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, whereas the participants in the "control group" kept on sitting quietly without legs soaking during the additional 20-minute period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain visual analog scale, pre-test
Pain visual analog scale was fulfilled as pain assessment before the intervention of menstruation day 1. The pain visual analog scale uses the 10 cm horizontal scale with verbal descriptors, the pain intensity could be graded from "no pain" (score of 0)" to "worst imaginable pain" (score of 10).
Measured: Before the intervention of menstruation day 1
Pain visual analog scale, post-test
Pain visual analog scale was fulfilled as pain assessment after the intervention of menstruation day 2. The pain visual analog scale uses the 10 cm horizontal scale with verbal descriptors, the pain intensity could be graded from "no pain" (score of 0)" to "worst imaginable pain" (score of 10).
Measured: After the intervention of menstruation day 2
Short-Form McGill Pain Questionnaire, pre-test
Short-Form McGill Pain Questionnaire was fulfilled as pain assessment before the intervention of menstruation day 1. It consists of 15 descriptors including 11 descriptors in the sensory subscale and four descriptors in the affective subscale. The pain intensity is scored from "none" (score 0) to "severe" (score 3) for each descriptor, summing the total pain rate index score of 0-45.
Measured: Before the intervention of menstruation day 1
Short-Form McGill Pain Questionnaire, post-test
Short-Form McGill Pain Questionnaire was fulfilled as pain assessment after the intervention of menstruation day 2. It consists of 15 descriptors including 11 descriptors in the sensory subscale and four descriptors in the affective subscale. The pain intensity is scored from "none" (score 0) to "severe" (score 3) for each descriptor, summing the total pain rate index score of 0-45.
Measured: After the intervention of menstruation day 2
Heart rate variability, pre-test of day 1
Heart rate variability was measured before the interventions on day 1 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio.
Measured: Before the interventions on day 1
Heart rate variability, post-test of day 1
Heart rate variability was measured after the interventions on day 1 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio.
Measured: After the interventions on day 1
Heart rate variability, pre-test of day 2
Heart rate variability was measured before the interventions on day 2 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio.
Measured: Before the interventions on day 2
Heart rate variability, post-test of day 2
Heart rate variability was measured after the interventions on day 2 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio.
Measured: After the interventions on day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Dec 2013
- Primary completion30 Jun 2014
- Study completion30 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camillians Saint Mary's Hospital Luodong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu Shih-Ju, Principal investigator, Saint Mary's Hospital Luodong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071028
- Sponsor's protocol ID
- SMHL_HRVnFB
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu SJ, Kan WC, Shiao CC. Warm-water footbath improves dysmenorrhoea and heart rate variability in college students: a randomised controlled trial. J Obstet Gynaecol. 2022 Jul;42(5):1204-1210. doi: 10.1080/01443615.2021.1945007. Epub 2021 Sep 24.
PubMed 34560833
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability as an Indicator Associated With the Improvement of Dysmenorrhea After the Warm-water Footbath
- ClinicalTrials.gov ID
- NCT04071028
- Acronym / sponsor ID
- SMHL_HRVnFB
- Conditions
- Primary Dysmenorrhea
- Keywords
- footbath, parasympathetic activity, primary dysmenorrhea, sympathetic activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Camillians Saint Mary's Hospital LuodongUniversity, hospital or other
- Study start
- 15 Dec 2013 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 28 Aug 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.
The effect of warm-water footbath in improving primary dysmenorrhea (PD) was rarely investigated previously. We aimed to exam the hypothesis that warm-water footbath is effective to reduce the pain of PD, and the effect is associated with changes in the autonomic nervous system (ANS) activity.
The quasi-experimental study was carried out enrolling 68 college students) with PD. The enrolled participants were randomized into two groups and received interventions (footbath (n=35) versus sitting only (n=33)) for 20 minutes per day on their menstruation days 1 and 2.
After the interventions, we analyzed the association among intervention (with footbath versus without footbath), heart rate variability (HRV) changes and changes of pain scales (Pain Visual Analog Scale and short-form McGill Pain Questionnaire).
Detailed description
Dysmenorrhea is the most common gynecological condition affecting 16% to 95% of adolescents and young women, and reduce their quality of life. Primary dysmenorrhea (PD), a term denoting the dysmenorrhea in the absence of underlying pathology, is commonly referred to as period pain or menstrual cramps by the lay press and public.
The effect of warm-water footbath in improving primary dysmenorrhea (PD) was rarely investigated previously. We aimed to exam the hypothesis that warm-water footbath is effective to reduce the pain of PD, and the effect is associated with changes in the autonomic nervous system (ANS) activity.
This study was approved by the Institutional Review Board of Saint Mary Hospital Luodong (SMHIRB102015).
This study with a quasi-experimental design was conducted in a nursing college in Northern Taiwan during the study period from December 1, 2013, to June 30, 2014. Participants were eligible for enrollment if they: (1) were healthy female students aged 16-20 years of the nursing college; (2) had regular menstrual cycles; (3) experienced dysmenorrhea within 6 months before the enrollment; (4) had dysmenorrhea with severity higher than five scores of the pain visual analog scale (PVAS); and (5) had no experience of pregnancy. The exclusion criteria included individuals whom: (1) had irregular menstrual cycles; (2) had circulation problem of legs such as peripheral arterial occlusive disease or deep vein thrombosis; (3) had wounds or skin lesions over legs; and (4) had taken any medications which affect ANS activity. The suggested participant's number estimated by the G-Power was 34 when setting the calculated power as 0.8 and α as 0.05. Considering participant loss during the study process, we decided to enroll 68 participants.
All enrolled participants were randomized into the footbath group (n=35) and control group (n=33). The baseline demographic data, as well as relevant information about menstrual cycles and dysmenorrhea of all participants, were documented at enrollment. All the participants were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, the participants in the "footbath group" received legs soaking from the heel to the Sanyinjiao (SP6) acupoint (above the ankle) 24 in 42 ℃ water with air bubbles and vibration given to the soles for 20 minutes, whereas the participants in the "control group" kept on sitting quietly without legs soaking during the additional 20-minute period.
PVAS and Short-Form McGill Pain Questionnaire (SF-MPQ) were fulfilled as pain assessment by all participants twice, including a "pre-test" before the intervention of menstruation day 1 and a "post-test" after the intervention of menstruation day 2.
HRV was measured at four time points (before and immediately after the interventions on days 1 and 2) to assess ANS function for all participants.
The interventions were "warm-water footbath for 20 minutes" for the "footbath group" and "sitting quietly without footbath for 20 minutes" for the "control group." Then we evaluated the influence of warm-water footbath on dysmenorrhea and several variables, including HRV indices and stiffness index.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Footbath group | Active comparator | Procedure: warm-water footbathAll the participants were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, the participants in the "footbath group" received legs soaking from the heel to the Sanyinjiao (SP6) acupoint (above the ankle) 24 in 42 ℃ water with air bubbles and vibration given to the soles for 20 minutes, |
| Control group | No intervention | –All the participants were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, whereas the participants in the "control group" kept on sitting quietly without legs soaking during the additional 20-minute period. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- healthy female students aged 16-20 years of the nursing college;
- had regular menstrual cycles;
- experienced dysmenorrhea within 6 months before the enrollment;
- had dysmenorrhea with severity higher than five scores of the pain visual analog scale (PVAS); and
- had no experience of pregnancy.
Key exclusion criteria (4 listed)
- had irregular menstrual cycles;
- had circulation problem of legs such as peripheral arterial occlusive disease or deep vein thrombosis;
- had wounds or skin lesions over legs; and
- had taken any medications which affect ANS activity.
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 |
|---|---|---|
| warm-water footbathAll the participants in the intervention group were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, the participants in the "footbath group" received legs soaking from the heel to the Sanyinjiao (SP6) acupoint (above the ankle) 24 in 42 ℃ water with air bubbles and vibration given to the soles for 20 minutes, whereas the participants in the "control group" kept on sitting quietly without legs soaking during the additional 20-minute period. | Procedure or surgery | Footbath group |
Primary outcome
Pain visual analog scale, pre-test
Time frame: Before the intervention of menstruation day 1
Pain visual analog scale was fulfilled as pain assessment before the intervention of menstruation day 1. The pain visual analog scale uses the 10 cm horizontal scale with verbal descriptors, the pain intensity could be graded from "no pain" (score of 0)" to "worst imaginable pain" (score of 10).
Pain visual analog scale, post-test
Time frame: After the intervention of menstruation day 2
Pain visual analog scale was fulfilled as pain assessment after the intervention of menstruation day 2. The pain visual analog scale uses the 10 cm horizontal scale with verbal descriptors, the pain intensity could be graded from "no pain" (score of 0)" to "worst imaginable pain" (score of 10).
Short-Form McGill Pain Questionnaire, pre-test
Time frame: Before the intervention of menstruation day 1
Short-Form McGill Pain Questionnaire was fulfilled as pain assessment before the intervention of menstruation day 1. It consists of 15 descriptors including 11 descriptors in the sensory subscale and four descriptors in the affective subscale. The pain intensity is scored from "none" (score 0) to "severe" (score 3) for each descriptor, summing the total pain rate index score of 0-45.
Short-Form McGill Pain Questionnaire, post-test
Time frame: After the intervention of menstruation day 2
Short-Form McGill Pain Questionnaire was fulfilled as pain assessment after the intervention of menstruation day 2. It consists of 15 descriptors including 11 descriptors in the sensory subscale and four descriptors in the affective subscale. The pain intensity is scored from "none" (score 0) to "severe" (score 3) for each descriptor, summing the total pain rate index score of 0-45.
Heart rate variability, pre-test of day 1
Time frame: Before the interventions on day 1
Heart rate variability was measured before the interventions on day 1 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio.
Heart rate variability, post-test of day 1
Time frame: After the interventions on day 1
Heart rate variability was measured after the interventions on day 1 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio.
Heart rate variability, pre-test of day 2
Time frame: Before the interventions on day 2
Heart rate variability was measured before the interventions on day 2 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio.
Heart rate variability, post-test of day 2
Time frame: After the interventions on day 2
Heart rate variability was measured after the interventions on day 2 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio.
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 28 Aug 2019.
- Derived from this study: PubMed 34560833Wu SJ, Kan WC, Shiao CC. Warm-water footbath improves dysmenorrhoea and heart rate variability in college students: a randomised controlled trial. J Obstet Gynaecol. 2022 Jul;42(5):1204-1210. doi: 10.1080/01443615.2021.1945007. Epub 2021 Sep 24.
- Individual participant dataSharing planned: No
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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.
Wu Shih-Ju principal investigator
Saint Mary's Hospital Luodong
Questions about this trial
What is this clinical trial studying?
A study testing warm-water footbath in people with Primary Dysmenorrhea, run by Camillians Saint Mary's Hospital Luodong.
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 5 inclusion and 4 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain visual analog scale, pre-test (time frame: Before the intervention of menstruation day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04071028, which also lists 1 linked publication.
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 28 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.