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WH: Hormone Estradiol Replacement Therapy Additional Herbals

Sponsor
Trieu, Nguyen Thi, M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT02618148
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
76.9
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ESTROGEN HERBALS 21
  • Drug: ESTROGEN HERBALS 28
 Phase 4

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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Health Services Research
Official Title:
The Natural Ingredients and Artificial Made Ready, a Good Combination Reduced the Risk of Thrombosis, Concerns With Their Use of HRT
Actual Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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.
Other Names:
  • EPGANA 21

    		•
    Experimental: 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.

    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.
    Other Names:
  • EPGANA 28

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to Estradiol > 35 pg / ml [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 Outcome Measures

    1. Time to Estradiol > 35 pg / ml [2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saigon Biopharma Company Limited Ho Chi Minh City Vietnam 700000

    Sponsors and Collaborators

    • Trieu, Nguyen Thi, M.D.

    Investigators

    • Study Director: Tran Minh Cam Tu, Dr., Nguyen Thi Trieu, Dr.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Nguyen Thi Trieu, MD, Sponsor, Trieu, Nguyen Thi, M.D.
    ClinicalTrials.gov Identifier:
    NCT02618148
    Other Study ID Numbers:
    • Estrogen Herbals
    First Posted:
    Dec 1, 2015
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Estrogens

    Study Results

    No Results Posted as of Oct 14, 2021