Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25 (NUTRITION; GYN)

Cornell University

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen

Study type: Interventional

Funder types: Other

Identifiers

NCT06227676

IRB0145243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Granola Bites

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen

Cramp Bites

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen