A Phase 2/3 interventional study of Cramp Bites by Aunt Flo's Kitchen in Dysmenorrhea Primary, Dysmenorrhea and Menstrual Discomfort, sponsored by Cornell University. Completed at 1 site in United States. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Cornell University · Phase 2/3, Interventional, and Treatment
Among 68 studies in Dysmenorrhea with a site in United States — 9 open to participants now, 11 under way, 1 of them phase 3. Dysmenorrhea · United States.
Among the 68 studies in Dysmenorrhea with a site in United States, this one is the 54th largest by enrollment of the 62 interventional ones that give a count, is one of 5 that started in 2022, is the only one in phase 2/3, and was the 54th registered.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
Browse Dysmenorrhea studies →9 of the 68 studies in Dysmenorrhea with a site in United States are open now. Recruiting first, the newest first:
Samphire Group, Inc. · Sites in United States
Western University of Health Sciences · Sites in United States
Helaina Inc. · Sites in United States
Samphire Group, Inc. · Sites in United States
Zenchi, Inc. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 57 Dysmenorrhea studies recruiting now, 7 (12%) set no upper age limit and 49 (86%) stop at 75 or younger; 11 take children under 18; 20 take healthy volunteers.
This study: 18 Years to 25 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
68 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 13 · Phase 3 16 · Phase 4 8
First in 2004; this study’s year is marked. 5 started in 2022.
This study's enrollment of 12 is below the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Median enrollment 73 across the 62 interventional studies, 291 across the 5 observational. Of the 51 that completed or were terminated, 21 (41%) have results posted.
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41 of 68 have an industry lead sponsor. The 10 most frequent:
Cornell University is the lead sponsor of 103 studies on the registry; 16 are open to participants now.
Cornell University has 1 study filed under Dysmenorrhea — fewer than ten, so there is no comparison to draw.
4 of the studies in Dysmenorrhea with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04333576Phase 3AbbVieStudy Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain | 2027-07 |
| NCT07524270Helaina Inc.Effera Dose Response: Women's Health | 2026-11 |
| NCT07679074Samphire Group, Inc.CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life | 2027-01-01 |
| NCT07508358Kevin HellmanVaginal Sildenafil for Primary Dysmenorrhea | 2027-06 |
Among the 68 studies in Dysmenorrhea with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen
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.
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.
Also known as: Aunt Flo's Kitchen, SheBalls LLC, Period Snack, Natural Period Snack, Armita Jamshidi, Period Cramp Food, Menstrual Cramp Food, Menstrual Cramp Alleviant, Period Pain Food, Menstrual Pain Food, Natural Period Cramp, Natural Menstrual Cramp
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes.
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.
Time frame: Participants were asked to fill out this survey at the end of the study. Completion time was 5 minutes.
Plan to share: No — Due to the privacy protection of participants, individual participant data will not be disclosed.
Ran from Jul 2022 to primary completion in Sep 2022, 1 month.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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