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

NCT03300999 | Completed

• 1 other identifier: 5170302
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Discomfort

Keywords

ginger tea

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  On any day between Day 1 and Day 28 of the first menstruation cycle. Cycle is 28 days.

• SF-36 Quality of Life Survey

  Day 28 of the second menstruation cycle. Cycle is 28 days.

• SF-36 Quality of Life Survey

  Day 28 of the third menstruation cycle. Cycle is 28 days.

Study Arms (2)

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.

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.

Interventions

ginger tea DIETARY_SUPPLEMENT

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.

Ginger Tea

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female with regular menstrual cycles
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda Health

Loma Linda, California, 92350, United States

Location

Study Officials

• Kyndra Woosley, MS RD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 4, 2017
• Study Start: November 14, 2017
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)