DiscomfortNCT03300999
The Effects of Daily Ginger Tea Consumption in Reducing Discomfort During Menstruation
A study testing ginger tea in people with Discomfort, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of our graduate student research study is to observe the effect of drinking ginger tea daily on period discomfort. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Discomfort
- What is being tested?
- ginger tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 2 Apr 2018
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female within age range
- regular menstrual cycles
- experiencing period cramps
- agrees to refrain from taking any pain medications, herbal supplements, or use home remedies such as heating pads that are known to alleviate menstrual cramps during the study period
- after sampling the ginger tea, the subject must agree to drink ginger tea daily.
Who cannot join
- women who take oral contraceptives
- work night shifts
- allergic to ginger
- lactating
- female-related uterine problems such as fibroids and polycystic ovarian syndrome who suffer from secondary dysmenorrhea
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of our graduate student research study is to observe the effect of drinking ginger tea daily on period discomfort.
Read the detailed description
- Day 1: Subjects will sign informed consent and will go over the introduction, purpose, procedures, and compliance with student investigators. Subjects will then be given a sample of ginger tea that will be used for the study and will be asked if they think they can drink this daily for a month. They will also be asked if they have regular menstrual cycles and agree to stop home remedies and stop taking pain medications or herbal supplements for a period of three menstruation cycles.
- Start/During the first menstruation cycle: Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given visual analog pain scales and symptom checklists that need to be completed during their second menstruation cycle.
- End of the first menstruation cycle - Start of the second menstruation cycle: Subjects will not take ginger tea, avoid home remedies, and refrain from taking pain medications or supplements.
- Start of the second menstruation cycle - End of the second menstruation cycle: Subjects will rate discomfort using the visual analog pain scales and symptom checklist during menstruation. Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given daily logs, visual analog pain scales, symptom checklists, and supplies for the ginger tea.
- End of the second menstruation cycle - Start of the third menstruation cycle: Subjects will take ginger tea daily, avoid home remedies, refrain from taking pain medications and supplements, and keep track of ginger tea intake by placing a check mark each day in the daily log checklist.
- Start of the third menstruation cycle - End of the third menstruation cycle: Subjects will rate discomfort using the visual analog pains scales and symptom checklist during menstruation.
- After the third menstruation cycle ends: Subjects will meet with student investigators at a location convenient to the subject to turn in daily logs, visual analog pain scales, and symptom checklists.
- Conditions
- Discomfort
- Being tested
- ginger tea
- Keywords
- ginger tea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ginger teaDietary supplement
- Ginger tea - Swanson Organic: 100% Certified Organic Ginger Root Tea
- Subjects will use one tea bag (contains two grams ginger root), mix with eight ounces of boiling water, steep for three minutes, and allow it to cool to room temperature before drinking. This will be done every day for one month before their third menstruation cycle and during their third menstruation cycle.
| Study group | Role | What they receive |
|---|---|---|
| Ginger Tea | Experimental | * End of the second menstruation cycle - Start of the third menstruation cycle: Subjects will take ginger tea daily, avoid home remedies, refrain from taking pain medications and supplements, and keep track of ginger tea intake by placing a check mark each day in the daily log checklist.
* Start of the third menstruation cycle - End of the third menstruation cycle: Subjects will drink ginger tea daily. Subjects will rate discomfort using the visual analog pain scales and the symptom checklist at the end of each day during menstruation.
* After the third menstruation cycle ends: Subjects will meet with student investigators at a location convenient to the subject to turn in daily logs, visual analog pain scales, and symptom checklists. Receives: Dietary Supplement: ginger tea |
| No Ginger Tea | No intervention | * End of the first menstruation cycle - Start of the second menstruation cycle: Subjects will not take ginger tea, avoid home remedies, and refrain from taking pain medications or supplements. * Start of the second menstruation cycle - End of the second menstruation cycle: Subjects will rate discomfort using the visual analog pain scales and symptom checklist during menstruation. Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given daily logs, visual analog pain scales, symptom checklists, and supplies for the ginger tea. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale
- The Visual Analogue scale is a form of a Likert scale that gives the interviewee maximum freedom to estimate their pain intensity. The interviewee will mark a line along the 10-cm scale which they perceive corresponds best to their exact pain intensity every day for the duration of the study. A score of zero indicated no pain and a score of 10 indicated the most severe pain felt.
Measured: Change between Day 1 of the Second Menstruation Cycle and Day 28 of the Second Menstruation Cycle. Cycle is 28 days.
Visual Analog Pain Scale
- The Visual Analogue scale is a form of a Likert scale that gives the interviewee maximum freedom to estimate their pain intensity. The interviewee will mark a line along the 10-cm scale which they perceive corresponds best to their exact pain intensity every day for the duration of the study. A score of zero indicated no pain and a score of 10 indicated the most severe pain felt.
Measured: Change between Day 1 of the Third Menstruation Cycle and Day 28 of the Third Menstruation Cycle. Cycle is 28 days.
Secondary outcomes (3)
SF-36 Quality of Life Survey
RAND developed this validated survey and it is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. This survey consists of eight scaled scores which are the weighted sums of the questions in each section. The sections include vitality, physical functioning, bodily pain, physical role functioning, general health perception, emotional role functioning, social role functioning, and mental health. Each scale is transformed into a 0-100 scale and the lower score indicates more disability while the higher represents less disability. It can take participants at least half an hour to complete and will be assessed over a one-month period.
Measured: On any day between Day 1 and Day 28 of the first menstruation cycle. Cycle is 28 days.
SF-36 Quality of Life Survey
RAND developed this validated survey and it is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. This survey consists of eight scaled scores which are the weighted sums of the questions in each section. The sections include vitality, physical functioning, bodily pain, physical role functioning, general health perception, emotional role functioning, social role functioning, and mental health. Each scale is transformed into a 0-100 scale and the lower score indicates more disability while the higher represents less disability. It can take participants at least half an hour to complete and will be assessed over a one-month period.
Measured: Day 28 of the second menstruation cycle. Cycle is 28 days.
SF-36 Quality of Life Survey
RAND developed this validated survey and it is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. This survey consists of eight scaled scores which are the weighted sums of the questions in each section. The sections include vitality, physical functioning, bodily pain, physical role functioning, general health perception, emotional role functioning, social role functioning, and mental health. Each scale is transformed into a 0-100 scale and the lower score indicates more disability while the higher represents less disability. It can take participants at least half an hour to complete and will be assessed over a one-month period.
Measured: Day 28 of the third menstruation cycle. Cycle is 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start14 Nov 2017
- Primary completion2 Apr 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiscomfortStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyndra Woosley, MS RD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300999
- Sponsor's protocol ID
- 5170302
- Status last verified
- Apr 2018
- First submitted
- 21 Sep 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Daily Ginger Tea Consumption in Reducing Discomfort During Menstruation
- ClinicalTrials.gov ID
- NCT03300999
- Acronym / sponsor ID
- 5170302
- Conditions
- Discomfort
- Keywords
- ginger tea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 4 Oct 2017 (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 purpose of our graduate student research study is to observe the effect of drinking ginger tea daily on period discomfort.
Detailed description
- Day 1: Subjects will sign informed consent and will go over the introduction, purpose, procedures, and compliance with student investigators. Subjects will then be given a sample of ginger tea that will be used for the study and will be asked if they think they can drink this daily for a month. They will also be asked if they have regular menstrual cycles and agree to stop home remedies and stop taking pain medications or herbal supplements for a period of three menstruation cycles.
- Start/During the first menstruation cycle: Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given visual analog pain scales and symptom checklists that need to be completed during their second menstruation cycle.
- End of the first menstruation cycle - Start of the second menstruation cycle: Subjects will not take ginger tea, avoid home remedies, and refrain from taking pain medications or supplements.
- Start of the second menstruation cycle - End of the second menstruation cycle: Subjects will rate discomfort using the visual analog pain scales and symptom checklist during menstruation. Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given daily logs, visual analog pain scales, symptom checklists, and supplies for the ginger tea.
- End of the second menstruation cycle - Start of the third menstruation cycle: Subjects will take ginger tea daily, avoid home remedies, refrain from taking pain medications and supplements, and keep track of ginger tea intake by placing a check mark each day in the daily log checklist.
- Start of the third menstruation cycle - End of the third menstruation cycle: Subjects will rate discomfort using the visual analog pains scales and symptom checklist during menstruation.
- After the third menstruation cycle ends: Subjects will meet with student investigators at a location convenient to the subject to turn in daily logs, visual analog pain scales, and symptom checklists.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger Tea | Experimental | Dietary Supplement: ginger tea* End of the second menstruation cycle - Start of the third menstruation cycle: Subjects will take ginger tea daily, avoid home remedies, refrain from taking pain medications and supplements, and keep track of ginger tea intake by placing a check mark each day in the daily log checklist. * Start of the third menstruation cycle - End of the third menstruation cycle: Subjects will drink ginger tea daily. Subjects will rate discomfort using the visual analog pain scales and the symptom checklist at the end of each day during menstruation. * After the third menstruation cycle ends: Subjects will meet with student investigators at a location convenient to the subject to turn in daily logs, visual analog pain scales, and symptom checklists. |
| No Ginger Tea | No intervention | –* End of the first menstruation cycle - Start of the second menstruation cycle: Subjects will not take ginger tea, avoid home remedies, and refrain from taking pain medications or supplements. * Start of the second menstruation cycle - End of the second menstruation cycle: Subjects will rate discomfort using the visual analog pain scales and symptom checklist during menstruation. Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given daily logs, visual analog pain scales, symptom checklists, and supplies for the ginger tea. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female within age range
- regular menstrual cycles
- experiencing period cramps
- agrees to refrain from taking any pain medications, herbal supplements, or use home remedies such as heating pads that are known to alleviate menstrual cramps during the study period
- after sampling the ginger tea, the subject must agree to drink ginger tea daily.
Key exclusion criteria (5 listed)
- women who take oral contraceptives
- work night shifts
- allergic to ginger
- lactating
- female-related uterine problems such as fibroids and polycystic ovarian syndrome who suffer from secondary dysmenorrhea
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 tea1. Ginger tea - Swanson Organic: 100% Certified Organic Ginger Root Tea • Subjects will use one tea bag (contains two grams ginger root), mix with eight ounces of boiling water, steep for three minutes, and allow it to cool to room temperature before drinking. This will be done every day for one month before their third menstruation cycle and during their third menstruation cycle. | Dietary supplement | Ginger Tea |
Primary outcome
Visual Analog Pain Scale
Time frame: Change between Day 1 of the Second Menstruation Cycle and Day 28 of the Second Menstruation Cycle. Cycle is 28 days.
• The Visual Analogue scale is a form of a Likert scale that gives the interviewee maximum freedom to estimate their pain intensity. The interviewee will mark a line along the 10-cm scale which they perceive corresponds best to their exact pain intensity every day for the duration of the study. A score of zero indicated no pain and a score of 10 indicated the most severe pain felt.
Visual Analog Pain Scale
Time frame: Change between Day 1 of the Third Menstruation Cycle and Day 28 of the Third Menstruation Cycle. Cycle is 28 days.
• The Visual Analogue scale is a form of a Likert scale that gives the interviewee maximum freedom to estimate their pain intensity. The interviewee will mark a line along the 10-cm scale which they perceive corresponds best to their exact pain intensity every day for the duration of the study. A score of zero indicated no pain and a score of 10 indicated the most severe pain felt.
3 secondary outcomes
SF-36 Quality of Life Survey
Time frame: On any day between Day 1 and Day 28 of the first menstruation cycle. Cycle is 28 days.
SF-36 Quality of Life Survey
Time frame: Day 28 of the second menstruation cycle. Cycle is 28 days.
SF-36 Quality of Life Survey
Time frame: Day 28 of the third menstruation cycle. Cycle is 28 days.
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 6 Apr 2018.
- 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.
Kyndra Woosley, MS RD principal investigator
Loma Linda University
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 tea in people with Discomfort, run by Loma Linda University at 1 site in United States.
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 5 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 6 Apr 2018. 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 United States. 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?
Visual Analog Pain Scale (time frame: Change between Day 1 of the Second Menstruation Cycle and Day 28 of the Second Menstruation Cycle. Cycle is 28 days.). The study lists 2 primary outcomes in all. 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 6 Apr 2018.