Clinical trial NCT06227676: Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25
Official title: Formative Assessment of the Effect of 'Cramp Bites' Intake on Primary Dysmenorrhea in Women Aged 18-25: A Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Keywords: Dysmenorrhea
Primary Dysmenorrhea
Menstrual Discomfort
Menstrual Pain
Menstrual Problem
Menstrual Cycle Abnormal
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
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Laidlaw Foundation
name: Epperson Fund
name: Beck Fellowship
name: Dan Cane Fund
First posted: 2024-01-29
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned either 'Cramp Bites' or our Placebo Snack over the duration of one menstrual cycle.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale for Spasmodic Cramps
timeFrame: 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.
measure: Visual Analogue Scale for Congestive Cramps
timeFrame: 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.
Secondary outcomes:
measure: Menstrual Symptom Questionnaire (MSQ)
timeFrame: Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes.
Other outcomes:
measure: Product Feedback Form
timeFrame: Participants were asked to fill out this survey at the end of the study. Completion time was 5 minutes.
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
Study officials:
References:
citation: Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015 Nov-Dec;21(6):762-78. doi: 10.1093/humupd/dmv039. Epub 2015 Sep 7.
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