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Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

Primary Purpose

Female Athlete Triad

Status

Withdrawn

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Acupuncture

Diet supplementary

About this trial

This is an interventional treatment trial for Female Athlete Triad focused on measuring sports injury, female athlete triad, acupuncture

Eligibility Criteria

17 Years - 25 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Sports medicine speciaized center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Acupuncture

diet modification

combined group

Arm Description

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

this group will receive diet using soy products a

will receive both acupuncture therapy and soy products

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03817827

First Posted

January 20, 2019

Last Updated

August 31, 2021

Sponsor

National Research Centre, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT03817827

Brief Title

Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Withdrawn

Why Stopped

The trial was delayed and patient recruitment was deemed high-risk during the Covid-19 pandemic

Study Start Date

May 5, 2018 (Actual)

Primary Completion Date

March 5, 2019 (Anticipated)

Study Completion Date

June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Research Centre, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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 .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Female Athlete Triad

Keywords

sports injury, female athlete triad, acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

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

Arm Title

diet modification

Arm Type

Experimental

Arm Description

this group will receive diet using soy products a

Arm Title

combined group

Arm Type

Experimental

Arm Description

will receive both acupuncture therapy and soy products

Intervention Type

Other

Intervention Name(s)

Acupuncture

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Diet supplementary

Intervention Description

Diet supplementary with soy product

Primary Outcome Measure Information:

Title

follicle stimulating hormone

Description

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

Time Frame

three months

Title

Luteinizing hormone

Description

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

Time Frame

three months

Title

estradiol 2

Description

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

Time Frame

three months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Sports medicine speciaized center

City

Cairo

State/Province

Nasr City

ZIP/Postal Code

46374

Country

Egypt

12. IPD Sharing Statement

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Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

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