Hormone Estradiol Replacement Therapy Additional Herbals

NCT ID: NCT02618148

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-06-30

Brief 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.

Detailed 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.

Conditions

Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ESTROGEN HERBALS 21

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

ESTROGEN HERBALS 28

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

EPGANA 21; EPGANA 28

Eligibility Criteria

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;

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Trieu, Nguyen Thi, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Nguyen Thi Trieu, MD

Sponsor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tran Minh Cam Tu, Dr.

Role: STUDY_DIRECTOR

Nguyen Thi Trieu, Dr.

Locations

Saigon Biopharma LLC

Wilmington, Delaware, United States

Saigon Biopharma Company Limited

Ho Chi Minh City, , Vietnam

Countries

United States; Vietnam

Related Links

https://en.wikipedia.org/wiki/Garlic

Garlic Oil

https://en.wikipedia.org/wiki/Nattokinase

Nattokinase

http://www.nativeremedies.com/ailment/low-progesterone-levels-information.html

Progesterone

https://www.nhs.uk/conditions/hormone-replacement-therapy-hrt/types/

Estradiol

Other Identifiers

Estrogen Herbals

Identifier Type: -

Identifier Source: org_study_id