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.

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

Dysmenorrhea Primary

Dysmenorrhea

Menstrual Discomfort

Menstrual Problem

Menstrual Cycle Abnormal

Menstrual Pain

Period Pain

Period Problem

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

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.

Cramp Bites by Aunt Flo's Kitchen

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

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.

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.

Women's Health Student

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

This snack contains no known spices or nutrients that have been shown to help with
spasmodic or congestive dysmenorrhea. It is the same shape and size as the active
comparator.

This snack contains spices and ingredients that have been shown to help with both
spasmodic and congestive dysmenorrhea. It is the same shape and size as the placebo
comparator.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status