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临床试验/NCT03817827
NCT03817827撤回不适用

Effect of Acupuncture and Diet Modification on Amenorrhea in Female Athlete Triad

National Research Centre, Egypt2 个研究点 分布在 1 个国家开始时间: 2018年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
follicle stimulating hormone

研究概览

简要总结

The present study will be designed to investigate the effect of acupuncture and diet modification using soy products on amenorrhea in female athlete triad.

For this purpose this study will be carried out on sixty female athletes participating gymnastics. They will be recruited from Sports Medicine specialized center in Nasr City, their ages will range from 17 to 25 years old and their BMI will be < 20 Kg/m2 .

详细描述

The subjects will be divided into three groups equal in number, matched for measured variable:

Group (A): Acupuncture only will be used in this group for 30 minutes, three times per week for twelve weeks. The acupuncture needles were inserted in points located on the abdomen.

Group (B): This group will receive only the diet modification contains soy products (phytoestrogen) as 100 milliliter soy milk and 100 grams soy beans daily in the morning as a breakfast alone to ensure its absorption, this dose had been taken for 12 weeks.

Group (C): This group will receive both acupuncture therapy for 30 minutes, three times per week for 12 weeks and diet modification contains soy products as 100 milliliter soy milk and 100 grams soy beans daily in the morning for 12 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 25 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients suffering from athletic amenorrhea.
  • Their age will be ranged from 17-25 years old.
  • Their body mass index will be less than 18.5 kg/m
  • No history of previous pregnancies.
  • No history of any pathological disease causing amenorrhea.
  • They are medically stable and consented to participate in the study.

排除标准

  • Patients with gynecological diseases that may cause amenorrhea.
  • Patients using contraceptive pills.
  • Patients using hormonal treatment.
  • Patients using induction of ovulation methods.
  • Patients following any other diet modification method.
  • Patients who receive any drug with side effect of amenorrhea.

结局指标

主要结局

follicle stimulating hormone

时间窗: three months

Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer

Luteinizing hormone

时间窗: three months

Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer

estradiol 2

时间窗: three months

Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer

次要结局

未报告次要终点

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Hazim Abbassy

Lecturer

National Research Centre, Egypt

研究点 (2)

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