Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

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

Conditions
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Female Athlete Triad

Intervention / Treatment
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* Other: Acupuncture
* Dietary Supplement: Diet supplementary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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/m2. No history of previous pregnancies. No history of any pathological disease causing amenorrhea. They are medically stable and consented to participate in the study. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>this group will receive Acupuncture therapy for 30 minutes three times per week | Other: Acupuncture<br>* this group will receive Acupuncture for 30 minutes three times per week<br>|
| Experimental: diet modification<br>this group will receive diet using soy products a | Dietary Supplement: Diet supplementary<br>* Diet supplementary with soy product<br>|
| Experimental: combined group<br>will receive both acupuncture therapy and soy products | Other: Acupuncture<br>* this group will receive Acupuncture for 30 minutes three times per week<br>Dietary Supplement: Diet supplementary<br>* Diet supplementary with soy product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follicle stimulating hormone | 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 | three months | 
| Luteinizing hormone | 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 | three months | 
| estradiol 2 | 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 | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sports injury, female athlete triad, acupuncture