MenopausePhase 4WHNCT02618148
Hormone Estradiol Replacement Therapy Additional Herbals
A Phase 4 study testing ESTROGEN HERBALS 21 and ESTROGEN HERBALS 28 in people with Menopause, run by Trieu, Nguyen Thi, M.D. at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- ESTROGEN HERBALS 21 and ESTROGEN HERBALS 28
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- Jan 2009to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Natural Ingredients and Artificial Made Ready, a Good Combination Reduced the Risk of Thrombosis, Concerns With Their Use of HRT
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.
Read the 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
- Being tested
- ESTROGEN HERBALS 21, ESTROGEN HERBALS 28
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTROGEN HERBALS 21Drug
Also called EPGANA 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.
ESTROGEN HERBALS 28Drug
Also called EPGANA 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.
| Study group | Role | What they receive |
|---|---|---|
| ESTROGEN HERBALS 21 | Experimental | 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. Receives: Drug: ESTROGEN HERBALS 21 |
| ESTROGEN HERBALS 28 | Experimental | 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. Receives: Drug: ESTROGEN HERBALS 28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 years
Secondary outcomes (1)
Time to Estradiol > 35 pg / ml
- Measure the time to Estradiol > 70 pg /ml.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJan 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Responsible party
- Principal investigator, Nguyen Thi Trieu, MD, Trieu, Nguyen Thi, M.D.
- Investigators
- Tran Minh Cam Tu, Dr., Study director, Nguyen Thi Trieu, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618148
- Sponsor's protocol ID
- Estrogen Herbals
- Acronym
- WH
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2015
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural Ingredients and Artificial Made Ready, a Good Combination Reduced the Risk of Thrombosis, Concerns With Their Use of HRT
- ClinicalTrials.gov ID
- NCT02618148
- Acronym / sponsor ID
- WH / Estrogen Herbals
- Conditions
- Menopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Study start
- Jan 2009 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESTROGEN HERBALS 21 | Experimental | Drug: ESTROGEN HERBALS 21Used 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. |
| ESTROGEN HERBALS 28 | Experimental | Drug: ESTROGEN HERBALS 28Used 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESTROGEN HERBALS 21Also: EPGANA 21Applies 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. | Drug | ESTROGEN HERBALS 21 |
| ESTROGEN HERBALS 28Also: EPGANA 28Applies 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 |
Primary outcome
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)
1 secondary outcome
Time to Estradiol > 35 pg / ml
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Garlic OilLink provided by the sponsor.
- NattokinaseLink provided by the sponsor.
- ProgesteroneLink provided by the sponsor.
- EstradiolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tran Minh Cam Tu, Dr. study director
Nguyen Thi Trieu, Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ESTROGEN HERBALS 21 and ESTROGEN HERBALS 28 in people with Menopause, run by Trieu, Nguyen Thi, M.D. at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Estradiol > 35 pg / ml (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.