Efficacy and Safety of HPC-03 for Postmenopausal Symptom
Paraules clau
Resum
Descripció
The results of preclinical efficacy evaluation of HPC-03 (Angelica gigas Nakai complex extract) obtained by mixing materials mentioned above showed that increase of serum estrogen level and increase of bone mineral density (BMD) of femur due to ALP(Alkaline phosphatase ) inhibition, bone related index (BALP,bone-specific alkaline phosphatase ; CTX- 1,C-terminal telopeptide-1 ; Osteocalcin).
Therefore, the investigators aimed to confirm the safety and efficacy of HPC-03 (a complex extract of Angelica gigas Nakai) which has been confirmed in preclinical studies, on the improvement of menopausal symptoms.
Dates
| Darrera verificació: | 01/31/2017 |
| Primer enviat: | 01/21/2017 |
| Inscripció estimada enviada: | 02/18/2017 |
| Publicat per primera vegada: | 02/22/2017 |
| Última actualització enviada: | 02/18/2017 |
| Publicació de l'última actualització: | 02/22/2017 |
| Data d'inici de l'estudi real: | 12/31/2016 |
| Data estimada de finalització primària: | 04/30/2017 |
| Data estimada de finalització de l’estudi: | 11/30/2017 |
Condició o malaltia
Intervenció / tractament
Dietary Supplement: HPC-03
Dietary Supplement: Placebo
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: HPC-03 To experimental arm randomly assigned, HPC-03 will administrated twice a day , two capsules each time (total dose of HPC-03: 2g/day) for 12 weeks (84days).
*(HPC-03: extracts of angelica gigas nakai, cnidium rhizome, and cinnamon bark.) | Dietary Supplement: HPC-03 HPC-03 is extracts of danggui (angelica gigas nakai), taeunggung (cnidium rhizome), and broilers (cinnamon bark). |
| Placebo Comparator: Placebo To control arm randomly assigned, placebo will administrated twice a day , two capsules each time for 12 weeks (84days). | Dietary Supplement: Placebo Placebo is constituted of crystalline cellulose(50.5%), corn starch(33.10%), caramel color(1.90%), anhydrous citric acid(1.25%), silicon dioxide(1.90%), carboxymethylcellulose calcium(6.25%), magnesium stearate(2.50%), and coater (3.10%). |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 40 Years Per a 40 Years |
| Sexes elegibles per estudiar | Female |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: 1. Women 40 to 60 years old who have passed one year or more since the last menstrual period 2. Women with a kupperman index score of 20 or higher 3. Women who have agreed to participate in this trial before the start of the clinical trial and who have written an informed consent Exclusion Criteria: 1. Women with a body mass index (BMI) greater than 30 kg / m2 2. Women using hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within 3 months 3. Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast or breast disease, sex hormone related cancer 4. A woman with a history of severe migraine within the past 1 year, diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty 5. Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants 6. Women with irregular uterine bleeding after 1 year of menopause 7. Patients with uncontrolled hypertension (160 / 100mmHg or higher, after 10 minutes of clinical test subjects) 8. Patients with diabetes whose blood sugar is not controlled (fasting glucose 180 mg / dL or diabetes mellitus within 3 months) 9. Those with uncontrolled thyroid disease (those who are considered to be able to participate in this trial by the tester can participate) 10. drug or alcohol abuser 11. If ALT(Alanine transaminase ) or AST(Aspartate transaminase) exceeds 3 times the normal upper limit of the research institute 12. If creatinine exceeds twice the upper limit of the normal level of research institute 13. Mammography / PAP smear If a clinically significant abnormality (Breast imaging-reporting and data system: BI-RADS category 0 or 3 or more, PAP smear is not abnormal up to ASCUS:atypical cells of undetermined significance) is confirmed (BI-RADS Category 0, ) 14. If you have participated in another clinical trial within one month of the start of this trial or plan to participate in another clinical trial during the trial period 15. If the tester judges that the test is inappropriate for this clinical trial 16. Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clopidogrel, etc.) within 3 months 17. Women who took medicines or health functional foods related to women's menopause within a month |
Resultat
Mesures de resultats primaris
1. Change from baseline Modified Kupperman Index score at 6 weeks and 12 weeks [At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo]
Mesures de resultats secundaris
1. endometrial thickness measured by transvaginal ultrasonography [At baseline and 12 weeks after administration of HPC-03]
2. serum estradiol (E2) [At baseline and 12 weeks after administration of HPC-03 or placebo]
3. serum FSH (Follicular stimulating hormone) [At baseline and 12 weeks after administration of HPC-03 or placebo]
Altres mesures de resultats
1. serum alkaline phosphatase [At screening and 6weeks and 12 weeks after administration of HPC-03 or placebo]
2. serum osteocalcin [At baseline and 6weeks and 12 weeks after administration of HPC-03 or placebo]
3. Urine N-terminal cross-linker telopeptidase [At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo]
