Efficacy and Safety Study of Ginseng Polysaccharide Extract
Maneno muhimu
Kikemikali
Tarehe
| Imethibitishwa Mwisho: | 05/31/2014 |
| Iliyowasilishwa Kwanza: | 05/31/2014 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 06/08/2014 |
| Iliyotumwa Kwanza: | 06/10/2014 |
| Sasisho la Mwisho Liliwasilishwa: | 06/08/2014 |
| Sasisho la Mwisho Lilichapishwa: | 06/10/2014 |
| Tarehe halisi ya kuanza kwa masomo: | 08/31/2012 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 03/31/2013 |
| Tarehe ya Kukamilisha Utafiti: | 11/30/2013 |
Hali au ugonjwa
Uingiliaji / matibabu
Dietary Supplement: Y-75
Dietary Supplement: Placebo
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Y-75 volunteers receive 3 packages twice a day up to 14 weeks | Dietary Supplement: Y-75 Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package |
| Placebo Comparator: Placebo volunteers receive 3 packages twice a day up to 14 weeks | Dietary Supplement: Placebo Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 50 Years Kwa 50 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Good general health Exclusion Criteria: - human immunodeficiency virus-1 infection - malignancy - active cardiovascular, renal, pulmonary, hepatic, neurological, psychiatric disease - recent (within 4 weeks) acute respiratory tract symptoms - immunosuppressive therapy including cytotoxic agents and corticosteroids - medication (within 4 weeks) deemed likely to interfere with the evaluation - history of allergic or other adverse reactions to ginseng products |
Matokeo
Hatua za Matokeo ya Msingi
1. Mean percentage change in natural killer cell activity from a baseline level [baseline (prior to the initial dose) , week 8, and week 14]
Hatua za Matokeo ya Sekondari
1. Changes from baseline in phagocytic activity of macrophages and polymorphonuclear cells [baseline, week 8, and week 14]
2. Changes from baseline in serum levels of tumor necrosis factor-alpha and interleukin-12 [baseline, week 8, and week 14]
3. Number of patients with laboratory abnormalities [baseline, week 8, and week 14]
4. Number of participants with serious and non-serious adverse events [Up to 14 weeks]
5. Number of patients with abnormal findings in physical examination and vital signs [baseline, week 8, and week 14]
