Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

Not Applicable

Withdrawn

• Conditions: Female Athlete Triad
• Interventions: Other: Acupuncture; Dietary Supplement: Diet supplementary

• Registration Number: NCT03817827
• Lead Sponsor: National Research Centre, Egypt

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-05-05
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-28
• Primary Completion: 2019-03-05
• Study Completion: 2019-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined group	Acupuncture	will receive both acupuncture therapy and soy products
Acupuncture	Acupuncture	this group will receive Acupuncture therapy for 30 minutes three times per week
diet modification	Diet supplementary	this group will receive diet using soy products a
combined group	Diet supplementary	will receive both acupuncture therapy and soy products

Primary Outcome Measures

Name	Time	Method
follicle stimulating hormone	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	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	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

Trial Locations

Locations (1)

Sports medicine speciaized center; 🇪🇬 Cairo, Nasr City, Egypt