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Hormone Estradiol Replacement Therapy Additional Herbals (WH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02618148
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Triệu, Nguyễn Thị, M.D.

Tracking Information
First Submitted Date  ICMJE November 14, 2015
First Posted Date  ICMJE December 1, 2015
Last Update Posted Date September 14, 2018
Study Start Date  ICMJE January 2009
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2015)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02618148 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2015)
Time to Estradiol > 35 pg / ml [ Time Frame: 2 years ]
- Measure the time to Estradiol > 70 pg /ml.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hormone Estradiol Replacement Therapy Additional Herbals
Official Title  ICMJE The Natural Ingredients and Artificial Made Ready, a Good Combination Reduced the Risk of Thrombosis, Concerns With Their Use of HRT
Brief Summary The purpose of this study is to determine whether safety Study of Hormone replacement therapy (HRT) with herbals( Garlic oil+Nattokinase) for estrogen deficiency symptoms in perimenopausal 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Menopause
Intervention  ICMJE
  • 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 Name: EPGANA 21
  • 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 Name: EPGANA 28
Study Arms  ICMJE
  • 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.

    Intervention: Drug: ESTROGEN HERBALS 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.

    Intervention: Drug: ESTROGEN HERBALS 28
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2015)
2
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02618148
Other Study ID Numbers  ICMJE Estrogen Herbals
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Triệu, Nguyễn Thị, M.D.
Study Sponsor  ICMJE Triệu, Nguyễn Thị, M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nguyen Thi Trieu, Master Tran Minh Duc, Dr.
PRS Account Triệu, Nguyễn Thị, M.D.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP