Clinical trial NCT03300999: The Effects of Daily Ginger Tea Consumption in Reducing Discomfort During Menstruation
Official title: The Effects of Daily Ginger Tea Consumption in Reducing Discomfort During Menstruation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Discomfort
Keywords: ginger tea
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. female within age range
2. regular menstrual cycles
3. experiencing period cramps
4. 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
5. after sampling the ginger tea, the subject must agree to drink ginger tea daily.

Exclusion Criteria:

1. women who take oral contraceptives
2. work night shifts
3. allergic to ginger
4. lactating
5. female-related uterine problems such as fibroids and polycystic ovarian syndrome who suffer from secondary dysmenorrhea

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Change between Day 1 of the Second Menstruation Cycle and Day 28 of the Second Menstruation Cycle. Cycle is 28 days.
measure: Visual Analog Pain Scale
timeFrame: Change between Day 1 of the Third Menstruation Cycle and Day 28 of the Third Menstruation Cycle. Cycle is 28 days.
Secondary outcomes:
measure: SF-36 Quality of Life Survey
timeFrame: On any day between Day 1 and Day 28 of the first menstruation cycle. Cycle is 28 days.
measure: SF-36 Quality of Life Survey
timeFrame: Day 28 of the second menstruation cycle. Cycle is 28 days.
measure: SF-36 Quality of Life Survey
timeFrame: Day 28 of the third menstruation cycle. Cycle is 28 days.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Health
state: California
Study officials:
affiliation: Loma Linda University
name: Kyndra Woosley, MS RD
role: PRINCIPAL_INVESTIGATOR
References: