Clinical trial NCT02618148: Hormone Estradiol Replacement Therapy Additional Herbals
Official title: The Natural Ingredients and Artificial Made Ready, a Good Combination Reduced the Risk of Thrombosis, Concerns With Their Use of HRT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Lead sponsor: Trieu, Nguyen Thi, M.D.
Sponsor class: INDIV
First posted: 2015-12-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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;

Primary outcomes:
measure: Time to Estradiol > 35 pg / ml
timeFrame: 1 years
Secondary outcomes:
measure: Time to Estradiol > 35 pg / ml
timeFrame: 2 years
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Saigon Biopharma LLC
state: Delaware
city: Ho Chi Minh City
country: Vietnam
facility: Saigon Biopharma Company Limited
Study officials:
affiliation: Nguyen Thi Trieu, Dr.
name: Tran Minh Cam Tu, Dr.
role: STUDY_DIRECTOR
References: