- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03817827
Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD
Effect of Acupuncture and Diet Modification on Amenorrhea in Female Athlete Triad
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 .
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nasr City
-
Cairo, Nasr City, Egypt, 46374
- Sports medicine speciaized center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture
this group will receive Acupuncture therapy for 30 minutes three times per week
|
this group will receive Acupuncture for 30 minutes three times per week
|
Experimental: diet modification
this group will receive diet using soy products a
|
Diet supplementary with soy product
|
Experimental: combined group
will receive both acupuncture therapy and soy products
|
this group will receive Acupuncture for 30 minutes three times per week
Diet supplementary with soy product
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
three months
|
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
|
three months
|
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
|
three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123 (Giresun University Scientific Research Project)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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