Report about the results of the tests of dietary supplement NightCap^TM in Narcological Hospital #17, city of Moscow

Clinical studies of NightCap conducted in Hospital number 17 support the methodic rules made by the Russian Ministry of Health concerning the clinical studies of new anti-intoxication supplements. 29 subjects, who suffered from the 2nd stage of chronic alcoholism, were the main group during the comparative studies. They were brought to the clinic in the condition of mild or medium alcoholic intoxication. All of them were normal healthy individuals with no somatic symptoms, had normal eating habits, and were between the ages of 25 and 45. The control group consisted of subjects analogically related to the main group according to chosen criteria (individual reactivity of the organism, stage of illness, the level of intoxication, primary syndrome, and were with or without chronic illnesses, etc.). The clinical study of the condition of the subjects was done with the Unified grade system of symptoms of alcoholic intoxication. There was no study done to determine the concentration of ethyl alcohol in the organisms of the subjects. Also, the individual differences in tolerance to and the speed of elimination of ethyl alcohol were not accounted for. The main criteria used to determine the effectiveness of the tested dietary supplement NightCap was its ability to increase the speed of disappearance of symptoms of alcoholic intoxication and appearance of hangover symptoms in comparison with routine detoxication therapy and placebo.
Based on the obtained results it is possible to conclude that compared to the control group, the speed of recovery from alcoholic intoxication in the group that used NightCap was actually increased without any hyper stimulation, or any sedative effect. While affecting positively the psychological clinical symptoms (the general exhibition of emotional and behavioral disruptions, the disruption of consciousness), NightCap did not cause any substantial effects on the disruptions of the vegetative regulation and neuromuscular disruptions. The side effects of dietary supplement NightCap were not recorded during the short-term therapy. At the same time, the evaluation of the condition of the subjects who continued taking the supplement after recovery from alcoholic intoxication at a dose of one package per day showed positive affects on such symptoms of alcoholic abstinence syndrome as flabbiness, extreme exhaustion, loss of will power, hypothermia, and similar pseudoastenic disturbances.
Therefore, the use of NightCap is logical at the stage of detoxication in narcological practices along with methods general used for anti-intoxication, and what is more important, at the stage of treatment of hangover syndromes expressed in light and medium stages with predominating of pseudoastenic disturbances in clinical picture.
Doctor of 17th Narcological Department
C.Golovin
Deputy of Head of Therapeutic Department
E.Tolkachev

Medical Center of Vasileostrov
Ph. 350-7786 or 130-4490

Recommendation of the use of dietary supplement NightCap^TM

Dietary supplement NightCap was used for 24 patients with alcoholism for recovery of normal condition and liver function. Liver function was determined by the level of bilirubin and transaminase. The general condition improved at the 3rd – 5th day, and liver function became normal by the 8th-10th day.
Dietary Supplement NightCap eliminated hangover symptoms, improved general health condition, cardio rhythm, recovered the ability to work, memory function, and eliminated the need for alcohol. This data was received by observing 17 patients. The other positive fact is that NightCap can be used practically as a new supplement to eliminate the need for alcohol and preventively recover the health of the patient.
Deputy of Chairman of the Association of
Experts in Psychiatry and Narcology
V. Antelava

Chief of R&D Department of the Military-Medical Academy
Professor C. Matveev
09/21/1999

Conclusion about the results of the tests of dietary supplement NightCap^TM as means of modification of the functional condition of the organism

From 03/09 to 04/07/1999 in Scientific Research Laboratory #7 of the Military Medical Academy the research was done on the effectiveness of the biologically active supplement NightCap on the functional condition of the organism. All studies were done on volunteers with simulation of acute alcohol intoxication.

The influence of the supplement on the functions of the cardiovascular system during the dosed intake of ethyl alcohol and indices of quality of the operational profile of the intact subjects have to be determined. In the materials present below, only the conclusions from achieved results have been shown. The complete report contains 46 pages including 18 tables.

The experiment was made with the participation of 10 healthy men (volunteers) of ages 28 to 38. Six of them participated in the experiment with dosed intake of alcohol, and four were intact. Two days before each experiment with alcohol, the tested subjects did not intake any alcohol, and did not eat anything two hours prior to the test.

CONCLUSIONS

NightCap is well tolerated by healthy people and does not have any negative effects on the functional condition of an organism if taken once.

1. After taking dietary supplement NightCap and following tests, accompanied by the appearance of hypoxia with increased level of carbon dioxide - physical activity, breath holding holding, complex senso-motor actions, - the intact subjects were observed to have an improvement in indices of general blood circulation and increase in the body’s resistance to effects of the above-mentioned factors. In the tested group the frequency of the heart beat during the test was on average lower by 11%, and systolic blood pressure higher by 7% than in the control group. The duration of breath holding after inhalation was 58-85% longer and 27-36% longer after exhalation depending of the variant of evaluation with comparison to the control group. The reliability of all shown effects is no less than 95%.
   More over, the tendency of increase of pulse pressure during the test in the tested group was determined, because of one part of tests was accompanied by a noticeable rise in systolic blood pressure while another part was accompanied by a decrease in diastolic blood pressure pressure.
2. Dietary supplement NightCap significantly decreases appearance of a narcotic effect of alcohol in such indices as static tremors and arterial pulse pressure. For example, if the impact of alcohol to the organism unprotected by NightCap provoked an increase in static tremors by more than 4 times and the decrease of pulse pressure by 19-40% during the tests, then the same tests done after the intake of NightCap along with alcohol showed the opposite results. Static tremors in the tested group were 2.3 times less and the pulse pressure of different subjects increased by 43-106% than in the control group. The increase of pulse pressure also correlates with a noticeable increase of systolic blood pressure.
3. When dietary supplement NightCap is taken at the same time as alcohol it decreases the worsening of tolerance to the combination of hypoxia and increased level of carbon dioxide by the organism, observed in the period of residual occurrences of acute alcohol intoxication. The significant effects distinguished by an increase of the duration of the breath holding, calculated by different methods were from +32% to 73% in comparison to the control group. The same factor dropped by 24 – 29% from beginning level for the subjects unprotected by NightCap.
   The frequency of heartbeats during the breath holding and complex senso-motor actions was lower by 13-19% in tested group than in control group. It correlates with the effect of the supplement to the intact subjects, but at the same time there were no noticeable differences in the initial condition at the stage of residual occurrences.
4. In some tests the dietary supplement NightCap caused a noticeable increase in systolic blood pressure and in another, a similarly noticeable decrease. In particular, the increase was noted in intact subjects just as well as in tested subjects 30-90 minutes after taking alcohol. A decrease was noticed after 16-17 hours after taking alcohol. The influence of alcohol in the narcotic phase is not significant and a decrease of systolic blood pressure has appeared as residual occurrences. Therefore, for the normalization of that factor the second dose of NightCap may be recommended in the morning after drinking alcohol.