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

NCT06227676 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-04-12

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • Laidlaw Foundation

    collaborator UNKNOWN
  • Epperson Fund

    collaborator UNKNOWN
  • Beck Fellowship

    collaborator UNKNOWN
  • Dan Cane Fund

    collaborator UNKNOWN
  • Cornell University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-21
Primary Completion
2022-09-15
Completion
2022-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227676 on ClinicalTrials.gov