Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

• ClinicalTrials.gov Identifier: NCT03817827
• Recruitment Status: Unknown
• First Posted: January 28, 2019
• Last Update Posted: January 28, 2019
• Sponsor: National Research Centre, Egypt
• Information provided by (Responsible Party): Amr Hazim Abbassy, National Research Centre, Egypt

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Female Athlete Triad	Other: Acupuncture; Dietary Supplement: Diet supplementary	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Acupuncture and Diet Modification on Amenorrhea in Female Athlete Triad
• Actual Study Start Date: May 5, 2018
• Estimated Primary Completion Date: March 5, 2019
• Estimated Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Acupuncture; this group will receive Acupuncture therapy for 30 minutes three times per week	Other: Acupuncture; this group will receive Acupuncture for 30 minutes three times per week
Experimental: diet modification; this group will receive diet using soy products a	Dietary Supplement: Diet supplementary; Diet supplementary with soy product
Experimental: combined group; will receive both acupuncture therapy and soy products	Other: Acupuncture; this group will receive Acupuncture for 30 minutes three times per week; Dietary Supplement: Diet supplementary; Diet supplementary with soy product

Outcome Measures

Primary Outcome Measures :

1. follicle stimulating hormone [ Time Frame: 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
2. Luteinizing hormone [ Time Frame: 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
3. estradiol 2 [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 17 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Amr H Abbassy, MD; +01001446860; abbassy2002@hotmail.com

Locations

Egypt

Sports medicine speciaized center; Recruiting

Cairo, Nasr City, Egypt, 46374

Contact: Hend Reda, Master +201010151300 hendsakr1986@gmail.com

Sponsors and Collaborators

National Research Centre, Egypt

More Information

• Responsible Party: Amr Hazim Abbassy, Lecturer, National Research Centre, Egypt
• ClinicalTrials.gov Identifier: NCT03817827
• Other Study ID Numbers: 123
• First Posted: January 28, 2019
• Last Update Posted: January 28, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amr Hazim Abbassy, National Research Centre, Egypt:

sports injury; female athlete triad; acupuncture

Additional relevant MeSH terms:

Female Athlete Triad Syndrome; Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Endocrine System Diseases; Feeding and Eating Disorders; Mental Disorders