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Hormone Estradiol Replacement Therapy Additional Herbals (WH)

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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.

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.

Condition or disease Intervention/treatment Phase
Menopause 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : January 2009
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: EPGANA 28




Primary Outcome Measures :
  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 Outcome Measures :
  1. Time to Estradiol > 35 pg / ml [ Time Frame: 2 years ]
    - Measure the time to Estradiol > 70 pg /ml.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618148


Sponsors and Collaborators
Triệu, Nguyễn Thị, M.D.
Investigators
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Study Director: Nguyen Thi Trieu, Master Tran Minh Duc, Dr.

Additional Information:
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Responsible Party: Triệu, Nguyễn Thị, M.D., Clinical Study
ClinicalTrials.gov Identifier: NCT02618148     History of Changes
Other Study ID Numbers: Estrogen Herbals
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Allyl sulfide
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors