The Effects of Daily Ginger Tea Consumption in Reducing Discomfort During Menstruation

• ClinicalTrials.gov Identifier: NCT03300999
• Recruitment Status: Completed
• First Posted: October 4, 2017
• Last Update Posted: April 6, 2018
• Sponsor: Loma Linda University
• Information provided by (Responsible Party): Loma Linda University

Study Description

Brief Summary:

The purpose of our graduate student research study is to observe the effect of drinking ginger tea daily on period discomfort.

Condition or disease	Intervention/treatment	Phase
Discomfort	Dietary Supplement: ginger tea	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Effects of Daily Ginger Tea Consumption in Reducing Discomfort During Menstruation
• Actual Study Start Date: November 14, 2017
• Actual Primary Completion Date: April 2, 2018
• Actual Study Completion Date: April 2, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Dietary Supplement: ginger tea; 1. 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.
No Intervention: No Ginger Tea; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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. ]
   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.
2. SF-36 Quality of Life Survey [ Time Frame: Day 28 of the second menstruation cycle. Cycle is 28 days. ]
   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.
3. SF-36 Quality of Life Survey [ Time Frame: Day 28 of the third menstruation cycle. Cycle is 28 days. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female with regular menstrual cycles
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

Loma Linda Health

Loma Linda, California, United States, 92350

Sponsors and Collaborators

Loma Linda University

Investigators

• Principal Investigator: Kyndra Woosley, MS RD; Loma Linda University

More Information

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT03300999
• Other Study ID Numbers: 5170302
• First Posted: October 4, 2017
• Last Update Posted: April 6, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Loma Linda University:

ginger tea