Dysmenorrhea PrimaryPhase 2/3NUTRITION; GYNNCT06227676
Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25
A Phase 2/3 study testing Cramp Bites by Aunt Flo's Kitchen in people with Dysmenorrhea Primary and Dysmenorrhea, run by Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea Primary, Dysmenorrhea, Menstrual Discomfort
- What is being tested?
- Cramp Bites by Aunt Flo's Kitchen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to 31 Oct 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 18 and 25 who experience primary dysmenorrhea and have no pathological disorders.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Formative Assessment of the Effect of 'Cramp Bites' Intake on Primary Dysmenorrhea in Women Aged 18-25: A Placebo-Controlled Trial
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.
Read the detailed 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.
- Conditions
- Dysmenorrhea Primary, Dysmenorrhea, Menstrual Discomfort, Menstrual Problem, Menstrual Cycle Abnormal, Menstrual Pain
- Being tested
- Cramp Bites by Aunt Flo's Kitchen
- Keywords
- Dysmenorrhea, Primary Dysmenorrhea, Menstrual Discomfort, Menstrual Pain, Menstrual Problem, Menstrual Cycle Abnormal, 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
- Medical subject headings
- Dysmenorrhea, Menstruation Disturbances, Premenstrual Syndrome, Polycystic Ovary Syndrome, Premenstrual Dysphoric Disorder, Muscle Cramp, Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cramp Bites by Aunt Flo's KitchenDietary supplement
Also called Aunt Flo's Kitchen, SheBalls LLC, Period Snack, Natural Period Snack
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.
| Study group | Role | What they receive |
|---|---|---|
| Granola Bites | Placebo comparator | 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. Receives: Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen |
| Cramp Bites | Active comparator | 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. Receives: Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 outcomes (1)
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.
Measured: Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start21 Jul 2022
- Primary completion15 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned either 'Cramp Bites' or our Placebo Snack over the duration of one menstrual cycle.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Laidlaw Foundation, Epperson Fund, Beck Fellowship, Dan Cane Fund
- Responsible party
- Principal investigator, Armita Jamshidi, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227676
- Sponsor's protocol ID
- IRB0145243
- Acronym
- NUTRITION; GYN
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the privacy protection of participants, individual participant data will not be disclosed.
Publications
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.
PubMed 26346058Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
PubMed 33030880Itani 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.
PubMed 35320895Chen 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.
PubMed 25059384Chesney 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.
PubMed 1238078Guimaraes 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.
PubMed 32559803Direkvand-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.
PubMed 23798928Mates 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.
PubMed 35883903Gutman 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.
PubMed 35523674Negriff 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.
PubMed 19786516
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Assessment of the Effect of 'Cramp Bites' Intake on Primary Dysmenorrhea in Women Aged 18-25: A Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06227676
- Acronym / sponsor ID
- NUTRITION; GYN / IRB0145243
- Conditions
- Dysmenorrhea Primary, Dysmenorrhea, Menstrual Discomfort, Menstrual Problem, Menstrual Cycle Abnormal, Menstrual Pain
- Keywords
- Dysmenorrhea, Primary Dysmenorrhea, Menstrual Discomfort, Menstrual Pain, Menstrual Problem, Menstrual Cycle Abnormal, Period Pain, Period Problem
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Laidlaw Foundation, Epperson Fund, Beck Fellowship, Dan Cane Fund
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned either 'Cramp Bites' or our Placebo Snack over the duration of one menstrual cycle.
| Arm | Type | Receives |
|---|---|---|
| Granola Bites | Placebo comparator | Dietary Supplement: Cramp Bites by Aunt Flo's KitchenThis 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. |
| Cramp Bites | Active comparator | Dietary Supplement: Cramp Bites by Aunt Flo's KitchenThis 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women between the ages of 18 and 25 who experience primary dysmenorrhea and have no pathological disorders.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cramp Bites by Aunt Flo's KitchenAlso: Aunt Flo's Kitchen, SheBalls LLC, Period Snack, Natural Period SnackParticipants 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. | Dietary supplement | Cramp Bites, Granola Bites |
Primary outcome
Visual Analogue Scale for Spasmodic Cramps
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.
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.
Visual Analogue Scale for Congestive Cramps
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.
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.
1 secondary outcome
Menstrual Symptom Questionnaire (MSQ)
Time frame: Participants complete this questionnaire with a researcher before the study. Time to complete this questionnaire is 15 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 26346058Iacovides 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.
- Background: PubMed 33030880Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
- Background: PubMed 35320895Itani 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.
- Background: PubMed 25059384Chen 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.
- Background: PubMed 1238078Chesney 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.
- Background: PubMed 32559803Guimaraes 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.
- Background: PubMed 23798928Direkvand-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.
- Background: PubMed 35883903Mates 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.
- Background: PubMed 35523674Gutman 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.
- Background: PubMed 19786516Negriff 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.
- Individual participant dataSharing planned: No. Due to the privacy protection of participants, individual participant data will not be disclosed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cramp Bites by Aunt Flo's Kitchen in people with Dysmenorrhea Primary and Dysmenorrhea, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Spasmodic Cramps (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227676, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.