Female Athlete TriadNCT03817827
Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD
A study testing Acupuncture and Diet supplementary in people with Female Athlete Triad, run by National Research Centre, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 25 years, women only
- Conditions the study is for
- Female Athlete Triad
- What is being tested?
- Acupuncture and Diet supplementary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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.
- Conditions
- Female Athlete Triad
- Being tested
- Acupuncture, Diet supplementary
- Keywords
- sports injury, female athlete triad, acupuncture
- Medical subject headings
- Female Athlete Triad Syndrome, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
this group will receive Acupuncture for 30 minutes three times per week
Diet supplementaryDietary supplement
Diet supplementary with soy product
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | this group will receive Acupuncture therapy for 30 minutes three times per week Receives: Other: Acupuncture |
| diet modification | Experimental | this group will receive diet using soy products a Receives: Dietary Supplement: Diet supplementary |
| combined group | Experimental | will receive both acupuncture therapy and soy products Receives: Other: Acupuncture; Dietary Supplement: Diet supplementary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start5 May 2018
- Primary completion5 Mar 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Why it stopped: The trial was delayed and patient recruitment was deemed high-risk during the Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Athlete TriadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Hazim Abbassy, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817827
- Sponsor's protocol ID
- 123
- Status last verified
- Aug 2021
- First submitted
- 20 Jan 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture and Diet Modification on Amenorrhea in Female Athlete Triad
- ClinicalTrials.gov ID
- NCT03817827
- Acronym / sponsor ID
- 123
- Conditions
- Female Athlete Triad
- Keywords
- sports injury, female athlete triad, acupuncture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial was delayed and patient recruitment was deemed high-risk during the Covid-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- 5 Mar 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncturethis group will receive Acupuncture therapy for 30 minutes three times per week |
| diet modification | Experimental | Dietary Supplement: Diet supplementarythis group will receive diet using soy products a |
| combined group | Experimental | Other: Acupuncture, Dietary Supplement: Diet supplementarywill receive both acupuncture therapy and soy products |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncturethis group will receive Acupuncture for 30 minutes three times per week | Other | Acupuncture, combined group |
| Diet supplementaryDiet supplementary with soy product | Dietary supplement | combined group, diet modification |
Primary outcome
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Diet supplementary in people with Female Athlete Triad, run by National Research Centre, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follicle stimulating hormone (time frame: three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.