Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06227676
Study type Interventional
Source Cornell University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date July 21, 2022
Completion date October 31, 2022

See also
  Status Clinical Trial Phase
Completed NCT03142633 - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Completed NCT06158932 - A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04932070 - Berberine and Polycystic Ovary Syndrome N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT03480022 - Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS Phase 3
Active, not recruiting NCT03043924 - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT05246306 - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Completed NCT05981742 - Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS Phase 2
Completed NCT05702957 - Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome Phase 2/Phase 3
Completed NCT05029492 - Effect of Visceral Manipulation on PCOS N/A
Not yet recruiting NCT02255578 - Endobarrier Treatment in Women With PCOS Phase 3
Completed NCT02924025 - Motivational Interviewing as an Intervention for PCOS N/A
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Completed NCT02098668 - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON N/A
Completed NCT01462864 - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome N/A
Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT00989781 - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome N/A