Hormone Estradiol Replacement Therapy Additional Herbals

Menopause Clinical Trial

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Official title:

The Natural Ingredients and Artificial Made Ready, a Good Combination Reduced the Risk of Thrombosis, Concerns With Their Use of HRT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618148
• Other study ID #: Estrogen Herbals
• Status: Completed
• Phase: Phase 4
• Start date: January 2009
• Est. completion date: June 2015

Study information

• Verified date: October 2021
• Source: Trieu, Nguyen Thi, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Hormone Replacement Therapy (HRT), safety studies are combined with herbal (garlic oil, rutin, and nattokinase) to reduce estrogen side effects. Making it safer when an endocrine supplement is needed for estrogen deficiency symptoms in menopausal and postmenopausal women.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• ESTROGEN HERBALS 21
Applies to the following strengths: 17ß-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.
• ESTROGEN HERBALS 28
Applies to the following strengths: 17ß-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.

Locations

Country	Name	City	State
Vietnam	Saigon Biopharma Company Limited	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Trieu, Nguyen Thi, M.D.

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Estradiol > 35 pg / ml	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)	1 years
Secondary	Time to Estradiol > 35 pg / ml	- Measure the time to Estradiol > 70 pg /ml.	2 years

External Links

•   Estradiol
•   Garlic Oil
•   Nattokinase
•   Progesterone