Clinical trial · Interventional
Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25
Formative Assessment of the Effect of 'Cramp Bites' Intake on Primary Dysmenorrhea in Women Aged 18-25: A Placebo-Controlled Trial
NCT06227676CI-TRIAL-00075967NUTRITION; GYNcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cramps | — | UNRESOLVED | — |
| Dysmenorrhea | — | UNRESOLVED | — |
| Dysmenorrhea Primary | — | UNRESOLVED | — |
| Menstrual Cycle Abnormal | — | UNRESOLVED | — |
| Menstrual Discomfort | — | UNRESOLVED | — |
| Menstrual Pain | — | UNRESOLVED | — |
| Menstrual Problem | — | UNRESOLVED | — |
| Ovarian Cysts | — | UNRESOLVED | — |
| PCOS | — | UNRESOLVED | — |
| PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cramp Bites by Aunt Flo's Kitchen | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Granola Bites
- description
- This snack contains no known spices or nutrients that have been shown to help with spasmodic or congestive dysmenorrhea. It is the same shape and size as the active comparator.
- interventionNames
- Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen
- type
- ACTIVE_COMPARATOR
- label
- Cramp Bites
- description
- This snack contains spices and ingredients that have been shown to help with both spasmodic and congestive dysmenorrhea. It is the same shape and size as the placebo comparator.
- interventionNames
- Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen
Primary outcomes (2)
- measure
- Visual Analogue Scale for Spasmodic Cramps
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDIacovides 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. PMID 26346058
- BACKGROUNDFerries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096. PMID 33030880
- BACKGROUNDItani 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. PMID 35320895
- BACKGROUNDChen 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. PMID 25059384
- BACKGROUNDChesney 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. PMID 1238078
- BACKGROUNDGuimaraes 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. PMID 32559803
- BACKGROUNDDirekvand-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. PMID 23798928
- BACKGROUNDMates 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.