Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

NCT03817827 | Withdrawn DMC

• 1 other identifier: 123
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 .

Conditions

Female Athlete Triad

Keywords

sports injury; female athlete triad; acupuncture

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Acupuncture

EXPERIMENTAL

this group will receive Acupuncture therapy for 30 minutes three times per week

Other: Acupuncture

diet modification

EXPERIMENTAL

this group will receive diet using soy products a

Dietary Supplement: Diet supplementary

combined group

EXPERIMENTAL

will receive both acupuncture therapy and soy products

Other: Acupuncture; Dietary Supplement: Diet supplementary

Interventions

Acupuncture OTHER

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

Acupuncture; combined group

Diet supplementary DIETARY_SUPPLEMENT

Diet supplementary with soy product

combined group; diet modification

Eligibility Criteria

• Age: 17 Years - 25 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

Sports medicine speciaized center

Cairo, Nasr City, 46374, Egypt

Location

MeSH Terms

Conditions

Female Athlete Triad Syndrome; Athletic Injuries

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Relative Energy Deficiency in Sport; Feeding and Eating Disorders; Mental Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 28, 2019
• Study Start: May 5, 2018
• Primary Completion: March 5, 2019
• Study Completion: June 30, 2019
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

EG (1)