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Completed

NCT Number: NCT06227676

Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25

85 percent of women of reproductive age experience consistent period cramps/menstrual pain, and 60% indicate that they do not use painkillers to relieve menstrual symptoms; there is a need for natural and non-medicative supplements to dysmenorrhea. The purpose of this clinical trial is to examine the effect of 'Cramp Bites'--classified by a mixture of natural ingredients researched to help with period pain--on women suffering from primary dysmenorrhea: this will be done through providing participants with the snack and surveying them on how it changes their period symptoms.

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Key information

Conditions

Dysmenorrhea Primary Adnexal Diseases Cramps Cysts Depressive Disorder Dysmenorrhea Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Menstrual Cycle Abnormal Menstrual Discomfort Menstrual Pain Menstrual Problem Menstruation Disturbances Mental Disorders Mood Disorders Muscle Cramp Muscular Diseases Musculoskeletal Diseases Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Ovarian Cysts Ovarian Diseases PCOS PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries PCOS (Polycystic Ovary Syndrome) of Left Ovary PCOS (Polycystic Ovary Syndrome) of Right Ovary PMS Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Period Pain Period Problem Polycystic Ovary Syndrome Premenstrual Dysphoric Disorder Premenstrual Syndrome Signs and Symptoms Urogenital Diseases

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cornell University

Ithaca, New York, 14853, United States

About this study

Participants will be asked the following information at the interview: name, month and year of birth, ethnicity, email, and phone number. As well, they will be prompted for their lifestyle habits, allergies, prior pregnancies and deliveries, presence of pathological disorders, medication (specifically asking about oral contraception), use of over-the-counter painkillers for period cramps/menstrual pain, expected date of next period, and menstrual cycle history. They will also be asked to complete the Menstrual Symptom Questionnaire.

The baseline questionnaire will ask the participant about their prior experience with primary dysmenorrhea symptoms and with period cramps/menstrual pain on a sliding scale.

The daily questionnaire will ask the participant to rate the extent of their period cramps/menstrual pain, to describe their pain, and whether they have taken any drugs for their period pain on that day. This questionnaire will be completed by all participants starting 2 days before their next onset of menstruation. Participants were randomly assigned Cramp Bites or the Placebo Snack: all other protocols remain the same.

After their next menstrual cycle ends, participants will be asked to fill out a final questionnaire: this questionnaire will ask the participant if they have noticed any changes in their period pain, the efficacy of the snack, and if they have suggestions/comments about the snack. This study is divided into 4 parts. Some parts will take place at Cornell University, and other parts can be completed online.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women between the ages of 18 and 25 who experience primary dysmenorrhea and have no pathological disorders.

Exclusion criteria

  • Pregnancy or breast feeding within 6 months
  • Primary or secondary amenorrhea
  • Body mass index less than the 1st percentile or body weight above 300 lbs
  • Undergoing menstrual suppression by medicative means
  • Unwilling to avoid painkillers (ibuprofen or naproxen) for the duration of the study unless absolutely necessary
  • Has allergies or aversions to ingredients used in either Cramp Bites or the Placebo Snack
  • Not fluent in English

Treatment and study plan

Cramp Bites by Aunt Flo's Kitchen

Dietary Supplement

Participants who are randomly assigned this snack are instructed to eat one serving each day, starting 2 days before their next onset of menstruation, and extending 3 days into their menstrual cycle. They are instructed to eat their assigned snack each time they experience menstrual cramps, whether spasmodic or congestive.

Other names: Aunt Flo's Kitchen, SheBalls LLC, Period Snack, Natural Period Snack, Armita Jamshidi, Period Cramp Food, Menstrual Cramp Food, Menstrual Cramp Alleviant, Period Pain Food, Menstrual Pain Food, Natural Period Cramp, Natural Menstrual Cramp

Primary outcomes

  1. Visual Analogue Scale for Spasmodic Cramps

    Time frame: Participants complete this survey when they experience cramps: once before they consume their snack, and once after. Completion time for each survey is 7 minutes.

    Participants rate their spasmodic cramp severity before and after eating either Cramp Bites or the Placebo Snack using the Visual Analogue Scale. This is on a scale from 0 to 10, where 0 represents no cramps and 10 indicates extreme abdominal cramping.

  2. Visual Analogue Scale for Congestive Cramps

    Time frame: Participants complete this survey when they experience cramps: once before they consume their snack, and once after. Completion time for each survey is 7 minutes.

    Participants rate their congestive cramp severity before and after eating either Cramp Bites or the Placebo Snack using the Visual Analogue Scale. This is on a scale from 0 to 10, where 0 represents no cramps and 10 indicates extreme abdominal cramping.

Secondary outcomes

  1. Menstrual Symptom Questionnaire (MSQ)

    Time frame: Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes.

    Filled out during intake exam. MSQ indicates to what extent the participant suffers from spasmodic cramps, congestive cramps, or a mixture of the two.

Other outcomes

  1. Product Feedback Form

    Time frame: Participants were asked to fill out this survey at the end of the study. Completion time was 5 minutes.

    Participants are asked to fill out a feedback form indicating how confident they were about their assigned snack's efficacy and the taste of the snack.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • Beck Fellowship
  • Dan Cane Fund
  • Epperson Fund
  • Laidlaw Foundation

Registry information

Official study title

Formative Assessment of the Effect of 'Cramp Bites' Intake on Primary Dysmenorrhea in Women Aged 18-25: A Placebo-Controlled Trial

Acronym: NUTRITION; GYN

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2024
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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