Skip to main content
OpenTrials
Completed

NCT Number: NCT02618148

Hormone Estradiol Replacement Therapy Additional Herbals

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Saigon Biopharma Company Limited

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ESTROGEN HERBALS 21

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.

Other names: EPGANA 21

ESTROGEN HERBALS 28

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.

Other names: EPGANA 28

Primary outcomes

  1. Time to Estradiol > 35 pg / ml

    Time frame: 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)

Secondary outcomes

  1. Time to Estradiol > 35 pg / ml

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Trieu, Nguyen Thi, M.D.

Indiv

Registry information

Official study title

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

Acronym: WH

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2015
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.