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Hormone Estradiol Replacement Therapy Additional Herbals

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliImekamilika
Wadhamini
Triệu, Nguyễn Thị, M.D.

Maneno muhimu

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho: 08/31/2018
Iliyowasilishwa Kwanza: 11/13/2015
Uandikishaji uliokadiriwa Uliwasilishwa: 11/25/2015
Iliyotumwa Kwanza: 11/30/2015
Sasisho la Mwisho Liliwasilishwa: 09/11/2018
Sasisho la Mwisho Lilichapishwa: 09/13/2018
Tarehe halisi ya kuanza kwa masomo: 12/31/2008
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 05/31/2015
Tarehe ya Kukamilisha Utafiti: 05/31/2015

Hali au ugonjwa

Menopause

Uingiliaji / matibabu

Drug: ESTROGEN HERBALS 21

Drug: ESTROGEN HERBALS 28

Awamu

Awamu 4

Vikundi vya Arm

MkonoUingiliaji / matibabu
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.

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 35 Years Kwa 35 Years
Jinsia Inastahiki KujifunzaFemale
Hupokea Wajitolea wa AfyaNdio
Vigezo

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;

Matokeo

Hatua za Matokeo ya Msingi

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)

Hatua za Matokeo ya Sekondari

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

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

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