Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

NCT ID: NCT03817827

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-05

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Female Athlete Triad

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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

diet modification

this group will receive diet using soy products a

Group Type EXPERIMENTAL

Diet supplementary

Intervention Type DIETARY_SUPPLEMENT

Diet supplementary with soy product

combined group

will receive both acupuncture therapy and soy products

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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

Diet supplementary

Intervention Type DIETARY_SUPPLEMENT

Diet supplementary with soy product

Interventions

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Acupuncture

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

Intervention Type OTHER

Diet supplementary

Diet supplementary with soy product

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Amr Hazim Abbassy

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sports medicine speciaized center

Cairo, Nasr City, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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123

Identifier Type: -

Identifier Source: org_study_id

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