CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
Cramp Bites by Aunt Flo's Kitchendietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06227676
NCT06227676Phase 3Completed

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

Cornell University·interventional·Posted Jan 29, 2024·Updated Apr 12, 2024

In Brief

A Phase 3 clinical trial evaluating Cramp Bites by Aunt Flo's Kitchen for Dysmenorrhea Primary and 17 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJan 29, 2024
Enrollment StartJul 21, 2022
Primary CompletionSep 15, 2022
Study CompletionOct 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.4 years ago

Interventions

Cramp Bites by Aunt Flo's Kitchendietary

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.