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

Polycystic Ovary Syndrome Clinical Trial

— NUTRITION; GYN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06227676
• Other study ID #: IRB0145243
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 21, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2024
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 31, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cramps
• Dysmenorrhea
• Dysmenorrhea Primary
• Menstrual Cycle Abnormal
• Menstrual Discomfort
• Menstrual Pain
• Menstrual Problem
• Menstruation Disturbances
• Muscle Cramp
• Ovarian Cysts
• PCOS
• Period Pain
• PMS
• Polycystic Ovary Syndrome
• Premenstrual Dysphoric Disorder
• Premenstrual Syndrome
• Spasm
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Cornell University	Ithaca	New York

Sponsors (5)

Lead Sponsor	Collaborator
Cornell University	Beck Fellowship, Dan Cane Fund, Epperson Fund, Laidlaw Foundation

Country where clinical trial is conducted

United States, 

References & Publications (10)

Chen CX, Kwekkeboom KL, Ward SE. Self-report pain and symptom measures for primary dysmenorrhoea: a critical review. Eur J Pain. 2015 Mar;19(3):377-91. doi: 10.1002/ejp.556. — View Citation

Chesney MA, Tasto DL. The development of the menstrual symptom questionnaire. Behav Res Ther. 1975 Oct;13(4):237-44. doi: 10.1016/0005-7967(75)90028-5. No abstract available. — View Citation

Direkvand-Moghadam A, Khosravi A. The impact of a novel herbal Shirazi Thymus Vulgaris on primary dysmenorrhea in comparison to the classical chemical Ibuprofen. J Res Med Sci. 2012 Jul;17(7):668-70. — View Citation

Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096. — View Citation

Guimaraes I, Povoa AM. Primary Dysmenorrhea: Assessment and Treatment. Rev Bras Ginecol Obstet. 2020 Aug;42(8):501-507. doi: 10.1055/s-0040-1712131. Epub 2020 Jun 19. — View Citation

Gutman G, Nunez AT, Fisher M. Dysmenorrhea in adolescents. Curr Probl Pediatr Adolesc Health Care. 2022 May;52(5):101186. doi: 10.1016/j.cppeds.2022.101186. Epub 2022 May 4. — View 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. — View Citation

Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary Dysmenorrhea: Pathophysiology, Diagnosis, and Treatment Updates. Korean J Fam Med. 2022 Mar;43(2):101-108. doi: 10.4082/kjfm.21.0103. Epub 2022 Mar 17. — View Citation

Mates L, Popa DS, Rusu ME, Fizesan I, Leucuta D. Walnut Intake Interventions Targeting Biomarkers of Metabolic Syndrome and Inflammation in Middle-Aged and Older Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Antioxidants (Basel). 2022 Jul 21;11(7):1412. doi: 10.3390/antiox11071412. — View Citation

Negriff S, Dorn LD, Hillman JB, Huang B. The measurement of menstrual symptoms: factor structure of the menstrual symptom questionnaire in adolescent girls. J Health Psychol. 2009 Oct;14(7):899-908. doi: 10.1177/1359105309340995. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Product Feedback Form	Participants are asked to fill out a feedback form indicating how confident they were about their assigned snack's efficacy and the taste of the snack.	Participants were asked to fill out this survey at the end of the study. Completion time was 5 minutes.
Primary	Visual Analogue Scale for Spasmodic Cramps	Participants rate their spasmodic cramp severity before and after eating either Cramp Bites or the Placebo Snack using the Visual Analogue Scale. This is on a scale from 0 to 10, where 0 represents no cramps and 10 indicates extreme abdominal cramping.	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.
Primary	Visual Analogue Scale for Congestive Cramps	Participants rate their congestive cramp severity before and after eating either Cramp Bites or the Placebo Snack using the Visual Analogue Scale. This is on a scale from 0 to 10, where 0 represents no cramps and 10 indicates extreme abdominal cramping.	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	Menstrual Symptom Questionnaire (MSQ)	Filled out during intake exam. MSQ indicates to what extent the participant suffers from spasmodic cramps, congestive cramps, or a mixture of the two.	Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes.