- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07739615
Effect of Soya Bean on the Female Reproductive Hormones and Menopausal Symptoms
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Menopause is one of the most emotionally, physically and Psychological miserable times in a woman's life.It occurs following cessation of menses resulting in the decline of endogenous estrogen. Phytoestrogens are natural plant derived compounds found in a wide variety of foods and soy bean is considered to be the richest source of plant estrogens. Current advances in management of menopause have relied on the use of hormone replacement therapy; however they are associated with adverse side effects if used over a long period of time. Currently, there is varying opinion regarding the physiological impact of soy bean consumption and results of studies are sparse and inconclusive. Hence, the need to determine the effect of soya bean consumption on the female reproductive hormones and relief of menopausal symptoms.
Sixty nine postmenopausal women will be randomized into three groups of 23 each. Group 1received 50g daily of the soya bean powder as tea for 28days, Group 2 received 100g daily of the soya bean powder as tea for 28days and Group 3 was on their normal diet and acts as control for 28days. Questionnaire and blood samples will be collected before and after the 28days for analysis. Blood will be assayed for the female reproductive hormone(Estrogen, Progesterone, Antimullerin hormone, FSH and LH), while standardized questionnaire will be used to get information on about objective of the study.
The generated data will be analyzed with International Business Machine Statistical Package for Social Science (IBM-SPSS) software version 22(Chicago II, USA) 2015. Students' t-test (t-test) will be used for comparison between groups for continuous variables while chi-square (χ2) test will be used for categorical variables. Values were expressed as mean ± SD. Statistical significance will be considered at P<0.05.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: DARLINTON-PETER CHIBUZOR UGOJI, FELLOWSHIP
- Telefonnummer: 08068748644
- E-post: darlingtonpeter2012@gmail.com
Studer Kontakt Backup
- Navn: Francis Iheanyichukwu Ugoji
- Telefonnummer: 08068748644
- E-post: darlingtonpeter2012@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Women who gave consent
- Absence of Menses for more than 1year that is not due to medical treatment
- More than 40years of age
Exclusion Criteria:
- Women on hormone replacement therapy
- Women on any hormonal medication
- Allergy to soya products.
- 40year old or lesser
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 50g Soya bean Group
Received 50g daily of the soya bean powder as tea for 28days and their usual daily diet
|
Soya bean is a phytoestrogen
|
|
Eksperimentell: 100g Soya bean group
Received 100g daily of the soya bean powder as tea for 28days and their usual daily diet
|
Soya bean is a phytoestrogen
|
|
Ingen inngripen: Normal Diet group
Was on their usual daily diet and acted as control for 28days.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in the Reproductive hormones
Tidsramme: 28days
|
Analysis of the Serum estrogen, progesterone, follicle stimulating hormone, lutenizing hormone and antimullerian hormone
|
28days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in menopausal symtoms
Tidsramme: 28days
|
Using questionaire and standardised tools to collect information about menopausal symtoms
|
28days
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: DARLINTON-PETER CHIBUZOR UGOJI, DAVID UMAHI FEDERAL UNIVERSITY TEACHING HOSPITAL UBURU, EBONYI STATE
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- EBSHREC 04/040
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .