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Résztvevőt keres itt: Egyesült ÁllamokFázis nélkül

An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms

A legfontosabb adatok

Ki végzi
Zenchi, Inc.
Hol
Las Vegas (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
42 fő, tervezett
Kezdés
2025. aug. 1.
Tervezett befejezés
2026. jan.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • Elix Daily Harmony
A regiszteradat frissítve
2025. szeptember 12.

Ki vehet részt

Életkor
20 év – 45 év
Nem
Csak nők
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 41 feltétel megnézéseKevesebb

Ki vehet részt

  • Be female
  • Be aged 20-45
  • BMI 18.5 - 24.9 kg/m2
  • Self-reported prior diagnosis of uterine fibroids
  • Anyone who is generally healthy - does not live with any uncontrolled chronic disease
  • Self-reported moderate to severe discomfort during menstruation, related to pelvic cramps, bloating, mood swings, or fatigue
  • Self-reported menstrual cramps during their cycle, for the past six months minimum
  • If taking hormonal birth control, has been doing so consistently for at least three months, and experiences a menstrual cycle with a period
  • If taking other oral over-the-counter supplements or herbal remedies, has been consistently taking these for at least three months prior to starting the study, and is willing to maintain this routine for the study duration
  • Willing to refrain from introducing any products or any new forms of medication or supplements for the study duration
  • Willing to refrain from any other dietary supplements or herbal remedies targeting the menstrual cycle during the study period
  • Willing to refrain from any new vaccines during the 6 month period
  • Follows 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
  • Agrees 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)
  • If using any other interventions, such as massage, chiropractic medicine, or acupuncture, agrees not to increase or decrease the number of these other interventions during the study period
  • Resides in the United States

Ki nem vehet részt

  • Anyone who has experienced significant weight loss in the past three months prior to study participation
  • Unwilling to stop the use of any medication or herbal remedies/supplements that can affect the menstrual cycle
  • Previous users of Elix Cycle Balance
  • History of hypertension, hyperlipidemia, or previous venous embolism
  • Hysterectomy, myomectomy, or bilateral salpingo-oophorectomy or other gynecological medical or surgical treatment in the last 6 months
  • Had a vaccine in the last 3 months
  • Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
  • Anyone with known severe allergic reactions
  • Anyone with any allergies or sensitivities to any of the study product ingredients
  • Anyone who has been diagnosed with the following conditions: PCOS, Endometriosis, PMDD, Adenomyosis, Hashimoto's thyroiditis, Grave's disease (and any other thyroid disorders), hyperprolactinemia, Cushing's disease, congenital adrenal hyperplasia, anorexia, bulimia, orthorexia, binge eating, any other eating disorder
  • History of endocrine disorders such as thyroid disorder, Type 1 or 2 diabetes, or other
  • Women with other causes of chronic pelvic pain, including infectious disease, gastrointestinal, psychological disorders, fibromyalgia, and chronic fatigue syndrome
  • History of an abnormal pap smear
  • History of neoplasia of gynecological origin and/or existence of uterine malformations
  • Chronic urinary tract infections or diagnosed functional gastrointestinal conditions like IBS, IBD, Crohn's disease, or ulcerative colitis
  • Does not experience a regular menstrual cycle (21-35 days)
  • Does not experience menstrual cramping
  • Follows an extreme diet intervention such as dry fasts, water fasts, or ketogenic diets
  • Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
  • Anyone unwilling to follow the study protocol
  • Has stopped, started, or changed hormonal birth control in the past three months
  • Anyone who is currently a smoker or has been a smoker in the past 3 months
  • Overweight/obesity (BMI > 25 kg/m2)
  • Currently partaking in another research study or will be partaking in any other research study for the next 24 weeks, or at any point during this study's duration
  • Consume more than 5 alcoholic drinks per week

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 20 és 45 év között vagy?

Helyszínek itt: Egyesült Államok

  • CitruslabsLas Vegas, Egyesült ÁllamokContact: Patrick Renner, MScRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

This is a 24-week, single-arm, open-label, virtual study evaluating the effects of Elix Cycle Balance and Elix Daily Harmony on uterine fibroid-related symptoms and quality of life in 42 participants. Participants will self-administer the investigational herbal supplements daily and complete validated questionnaires at scheduled timepoints to assess symptom severity and quality of life.

A vizsgálat csoportja

  • Elix Cycle Balance & Elix Daily HarmonyA vizsgált kezelés

    Participants will receive two investigational herbal supplements daily for 24 weeks.

    Kezelés: Elix Daily Harmony

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
An Open-Label, Single-Group Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
Illeszkedési kérdések
Forrás: NCT07078682: ki vehet részt
A regiszteradat frissítve
2025. szeptember 12.