Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

Female Athlete Triad Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03817827
• Other study ID #: 123
• Status: Withdrawn
• Phase: N/A
• Start date: May 5, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2021
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2019
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Athlete Triad

Intervention

Other:
• Acupuncture
this group will receive Acupuncture for 30 minutes three times per week

Dietary Supplement:
• Diet supplementary
Diet supplementary with soy product

Locations

Country	Name	City	State
Egypt	Sports medicine speciaized center	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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