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Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

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


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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817827


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 Center, Egypt

Responsible Party: Amr Hazim Abbassy, Lecturer, National Research Center, Egypt
ClinicalTrials.gov Identifier: NCT03817827     History of Changes
Other Study ID Numbers: 123
First Posted: January 28, 2019    Key Record Dates
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 Center, 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