跳至主要内容
临床试验/NCT06535698
NCT06535698已完成不适用

A Single-Group Clinical Trial to Evaluate the Effect of an Oral Supplement to Provide Relief From Symptoms of Hormonal Imbalance.

Perelel Inc.2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Changes in Symptoms of Hormonal Imbalance

研究概览

简要总结

This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Self-reported symptoms of hormonal imbalance (e.g., mood swings, irregular menstrual cycles)
  • Generally healthy without uncontrolled chronic diseases
  • Willing to avoid new hormonal balance treatments during the study
  • Consistent use of current hormonal balance treatments for at least 3 months prior to the study

排除标准

  • Chronic conditions preventing adherence to the protocol Diabetes
  • Planned hormonal balance-related procedures during the study
  • Started any new medications or supplements that target hormonal balance in the past 3 months
  • Anyone with diabetes
  • Severe allergies requiring EpiPen
  • Pregnant, breastfeeding, or trying to conceive
  • Recent surgeries or planned surgeries during the study
  • Unwilling to follow the study protocol

结局指标

主要结局

Changes in Symptoms of Hormonal Imbalance

时间窗: Baseline, Week 4, Week 8, Week 12

Evaluation of the effect of Perelel Health hormonal balance support on symptoms of hormonal imbalance using a self-reported questionnaire.

次要结局

  • Changes in Overall Menstrual Health(Baseline, Week 4, Week 8, Week 12)

研究者

发起方
Perelel Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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