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Hormone Estradiol Replacement Therapy Additional Herbals

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StatusConcluído
Patrocinadores
Triệu, Nguyễn Thị, M.D.

Palavras-chave

Resumo

The purpose of this study is to determine whether safety Study of Hormone replacement therapy (HRT) with herbals( Garlic oil+Nattokinase) for estrogen deficiency symptoms in perimenopausal and postmenopausal women.

Descrição

Recent studies have proved :

-Garlic oil as garlic may reduce platelet aggregation, patients taking anticoagulant medication are cautioned about consuming garlic.

A 2013 meta-analysis concluded that garlic preparations may effectively lower total cholesterol by 11-23 mg/dL and LDL cholesterol by 3-15 mg/dL in adults with high cholesterol if taken for longer than two months. The same analysis found that garlic had a marginally positive effect on HDL cholesterol, no significant effect on blood triglyceride levels, and that garlic preparations were generally well tolerated with very few side effects.

- Nattokinase Nattō is made from fermented soybeans and has been eaten in Japan for about a thousand years. Nattō is produced by fermentation by adding the bacterium Bacillus natto to boiled soybeans. Nattokinase is produced by the bacterium acting on the soybeans . While other soy foods contain enzymes, it is only the nattō preparation that contains the specific nattokinase enzyme.

- Estradiol valerate is one of the most widely used esters of estradiol.

- Progesterone: Hormone replacement therapy. Progesterone is combined with 17-beta estradiol in the estrogen patch.

datas

Última verificação: 08/31/2018
Enviado pela primeira vez: 11/13/2015
Inscrição estimada enviada: 11/25/2015
Postado pela primeira vez: 11/30/2015
Última atualização enviada: 09/11/2018
Última atualização postada: 09/13/2018
Data real de início do estudo: 12/31/2008
Data Estimada de Conclusão Primária: 05/31/2015
Data Estimada de Conclusão do Estudo: 05/31/2015

Condição ou doença

Menopause

Intervenção / tratamento

Drug: ESTROGEN HERBALS 21

Drug: ESTROGEN HERBALS 28

Fase

Fase 4

Grupos de Armas

BraçoIntervenção / tratamento
Experimental: ESTROGEN HERBALS 21
Used for women who wish to monthly menstruation Applies to the following strengths: 17β-estradiol 1.5mg/24 hours x 21 days, stop drinking for 7 days. Progesterone 5mg/24 hours x 10 days, stop drinking for 7 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.
Drug: ESTROGEN HERBALS 21
Applies to the following strengths: 17β-estradiol 1.5mg/24 hours x 21 days, stop drinking for 7 days. Progesterone 5 mg/24 hours x 10 days, stop drinking for 7 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.
Experimental: ESTROGEN HERBALS 28
Used for women who do not wish to monthly menstruation Applies to the following strengths: 17β-estradiol 1.5mg/24 hours x 28 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.
Drug: ESTROGEN HERBALS 28
Applies to the following strengths: 17β-estradiol 1.5mg/24 hours x 28 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.

Critério de eleição

Idades qualificadas para estudar 35 Years Para 35 Years
Sexos elegíveis para estudoFemale
Aceita Voluntários Saudáveissim
Critério

Inclusion Criteria:

- Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in perimenopausal and postmenopausal women.

- Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

Exclusion Criteria:

- Known, past or suspected breast cancer;

- Known or suspected oestrogen-dependent malignant tumours (eg endometrial cancer);

- Undiagnosed genital bleeding;

- Untreated endometrial hyperplasia;

- Previous or current venous thromboembolism (deep venous thrombosis,pulmonary embolism)

- Known thrombophilic disorders (eg protein C, protein S, or antithrombin deficiency, see section.

- Active or recent arterial thromboembolic disease (eg angina, myocardial infarction);

- Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;

- Known hypersensitivity to the active substances or to any of the excipients;

Resultado

Medidas de Resultado Primário

1. Time to Estradiol > 35 pg / ml [1 years]

Patients fulfilling inclusion and exclusion criteria. Measure the time to Estradiol > 35 pg / ml Will be divided into two groups Group (A): Females premenopausal Group (B): Females postmenopausal Females premenopausal: (Reference Range: (35-525 pg/mL) Females postmenopausal: (Reference Range:(0-35 pg/mL)

Medidas de Resultado Secundário

1. Time to Estradiol > 35 pg / ml [2 years]

- Measure the time to Estradiol > 70 pg /ml.

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