NCT06227676

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cornell University · Academic / Other
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dysmenorrhea Primary
• Dysmenorrhea
• Menstrual Discomfort
• Menstrual Problem
• Menstrual Cycle Abnormal
• Menstrual Pain
• Period Pain
• Period Problem
• PMS
• Premenstrual Syndrome
• PCOS
• PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• PCOS (Polycystic Ovary Syndrome) of Left Ovary
• PCOS (Polycystic Ovary Syndrome) of Right Ovary
• Polycystic Ovary Syndrome
• Premenstrual Dysphoric Disorder
• Cramps
• Ovarian Cysts

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cramp Bites by Aunt Flo's Kitchen	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.

Timeline

• Start date: 2022-07-21
• Primary completion: 2022-09-15
• Completion: 2022-10-31
• First posted: 2024-01-29
• Last updated: 2024-04-12

Locations

1 site across 1 country: United States