Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25
Condition: Dysmenorrhea Primary; Dysmenorrhea; Menstrual Discomfort; Menstrual Problem; Menstrual Cycle Abnormal; Menstrual Pain; 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
MeSH terms: Polycystic Ovary Syndrome; Ovarian Cysts; Muscle Cramp; Spasm; Syndrome; Dysmenorrhea; Premenstrual Syndrome; Premenstrual Dysphoric Disorder; Menstruation Disturbances
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): Cramp Bites by Aunt Flo's Kitchen
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Other intervention name(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned either 'Cramp Bites' or our Placebo Snack over the duration of one menstrual cycle.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
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