Red Ginseng Extract With Climacteric Symptoms
Klíčová slova
Abstraktní
Popis
A screening test is conducted for those who have agreed in writing with a detailed explanation of the purpose of this study and research methods, and then a person who meets the selection / exclusion criteria is selected.
Give a registration number to the person selected as the subject through the screening, and take one pack of the product (3g) once a day for 24 weeks in a human body application test.
Prior to taking the registration number (1Day), the efficacy evaluation items and the safety evaluation items are carried out. At the 24 weeks after the starting point of taking the product of human application test, the evaluation items are conducted through outpatient visits.
Termíny
| Poslední ověření: | 02/28/2019 |
| První předloženo: | 03/03/2019 |
| Odhadovaná registrace vložena: | 03/04/2019 |
| První zveřejnění: | 03/06/2019 |
| Poslední aktualizace byla odeslána: | 03/04/2019 |
| Poslední aktualizace zveřejněna: | 03/06/2019 |
| Aktuální datum zahájení studie: | 02/28/2019 |
| Odhadované datum dokončení primární: | 01/31/2020 |
| Odhadované datum dokončení studie: | 01/31/2020 |
Stav nebo nemoc
Intervence / léčba
Dietary Supplement: Korean Red Ginseng
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Experimental: Korean Red Ginseng Product: Red ginseng Everytime 1 pack(3g/day) | Dietary Supplement: Korean Red Ginseng Take one pack of the product (3g) once a day for 24 weeks |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 40 Years Na 40 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | Inclusion Criteria: 1. Age of 40~75 men and women 2. Those who visited the menopausal clinic with complaints of climacteric symptoms due to functional deterioration of various organs such as fatigue, helplessness 3. Those who have agreed to voluntarily decide to participate and observe the instructions after hearing the detailed explanation of this human body application test Exclusion Criteria: 1. Those who have suspected symptoms of acute disease (severe infectious disease, severe trauma, severe diarrhea, vomiting, etc.) 2. Patients with a history of antibiotic treatment for more than 1 month within the last 6 months 3. Those who have gastrointestinal diseases (inflammatory growth disease, active peptic ulcer, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) 4. Those taking health functional foods, lactic acid bacteria, and red ginseng extracts for the past year 5. Those who are currently participating in other clinical studies or human trials, or participating in clinical trials or human application tests within the past month |
Výsledek
Primární výsledná opatření
1. Changes in gut microbiota at 24 weeks vs baseline [24 weeks]
Měření sekundárních výsledků
1. Changes in Total Oxidant Status(TOS in µmol/L) at 24 weeks vs baseline [24 weeks]
2. Changes in Total Antioxidant Status(TAS in mmol/L) at 24 weeks vs baseline [24 weeks]
3. Changes in Natural Killer(NK) cell activity at 24 weeks vs baseline [24 weeks]
4. Changes in Heart rate variability at 24 weeks vs baseline [24 weeks]
