Clinical trial NCT06187376: Chinese Herbal Medicine for Gynecologic Patients
Official title: Evaluating the Safety and Acceptability of Using Chinese Herbal Medicine in Patients With Primary Dysmenorrhea: A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dysmenorrhea
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Zenchi, Inc.
First posted: 2024-01-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized-controlled trial looking at the safety and acceptability of using Chinese herbal medicine in patients with primary dysmenorrhea. The research team hopes to enroll 100 patients, 50 of whom will be randomized to receive the herbal tincture and 50 who will receive a placebo tincture. Patients will be enrolled and using the assigned tincture for twelve weeks. The research team will assess safety as a primary outcome by the presence or absence of adverse events related to study protocol during the period of participation.


Eligibility criteria: Inclusion Criteria:

* Female aged 18-36 are met:
* Self-reported pain or discomfort during menstruation, as indicated by Grade 1 or higher on the verbal multidimensional scoring system
* May experience regular menstrual cycle and period must be \<7 days in duration
* May be on birth control
* Must know or can estimate the date of the next cycle/period
* May find blood clots in menstrual blood
* Must be in good health (doesn't report any medical conditions asked in the screening questionnaire)
* Following a stable, consistent diet regimen
* Follow a stable, consistent exercise regimen and are willing, for the duration of the study, to not decrease or increase the amount of exercise in their regimen
* Agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study (for example, getting on or off hormonal birth control, reducing the amount of exercise)
* Follow a stable consistent regimen when using any other interventions, such as massage, chiropractic medicine, or acupuncture; agree not to increase or decrease the number of their other interventions
* Willingness to adhere to the dietary supplement regimen
* Willingness to refrain from any other dietary supplements targeting the menstrual cycle during the study period
* Is able to communicate in English
* Is willing and able to share feedback via REDCap
* Must provide written informed consent (ICF)

Exclusion Criteria:

* Do not experience a menstrual cycle
* Cannot estimate the onset of their next menstrual cycle
* Do not experience menstrual pain or cramping
* Follow an extreme diet intervention
* Experienced severe weight loss in the past 3 months prior to study participation
* If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study
* Food intolerances/allergies that require an EpiPen
* Known allergic reaction to any of the test product ingredients
* Currently pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
* Previous users of Elix Cycle Balance
* Having more than 3 alcoholic drinks a day
* Have been diagnosed with the following conditions: PCOS, endometriosis, PMDD, adenomyosis, Hashimoto's, anorexia, bulimia, orthorexia, binge eating, any other eating disorder
* Smokers
* Not been on a stable dose of birth control for the past 6 months

Primary outcomes:
measure: Presence or absence of any adverse events
timeFrame: up to 3 months
Secondary outcomes:
measure: Dysmenorrhea Symptom Interference (DSI) Scale
timeFrame: up to 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Faculty Practice Associates
state: New York
Study officials:
affiliation: Icahn School of Medicine
name: Nicola Tavella
role: STUDY_DIRECTOR
References: