Double-blind, placebo-controlled, randomised study of single dose effects of ADAPT-232 on cognitive functions.

The aim of this study was to assess the effect of a single dose of ADAPT-232 (a standardised fixed combination of Rhodiola rosea L., Schisandra chinensis (Turcz.) Baill., and Eleutherococcus senticosus Maxim) extracts on mental performance, such as attention, speed and accuracy, in tired individuals performing stressful cognitive tasks. The pilot study (phase IIa) clinical trial took the form of a double-blind, placebo-controlled, randomised, with two parallel groups. Forty healthy females aged between 20-68 years, who claimed to have felt stressed over a long period of time due to living under psychologically stressful conditions were selected to participate in the pilot study. In addition, a Stroop Colour-Word test (Stroop CW) was used to exhaust/prepare the volunteers prior to the d2 test used for assessment of cognitive function of patients. The participants were randomised into two groups, one (n=20) of which received a single tablet of ADAPT-232 (270mg), while a second (n=20) received a single tablet of placebo. The effects of the extract were measured prior to treatment and two hours after treatment using the d2 Test of Attention (d2). The results of the d2 test showed a significant difference (p<0.05) in attention, speed, and accuracy (TN-E scores) between the two treatment groups. The subjects in the ADAPT-232 group quickly (two hours after verum was taken) gained improved attention and increased speed and accuracy during stressful cognitive tasks, in comparison to placebo. There was also a tendency of ADAPT-232 to reduce percentage of errors, which means better accuracy, quality of the work, and degree of care in the volunteers under stressful conditions. No serious side effects were reported, although a few minor adverse events, such as sleepiness and cold extremities, were observed in both treatment groups.

Clinical trial of Rhodiola rosea L. extract SHR-5 in the treatment of mild to moderate depression.

The objective of this study was to assess the efficacy and safety of standardized extract SHR-5 of rhizomes of Rhodiola rosea L. in patients suffering from a current episode of mild/moderate depression. The phase III clinical trial was carried out as a randomized double-blind placebo-controlled study with parallel groups over 6 weeks. Participants, males and females aged 18-70 years, were selected according to DSM-IV diagnostic criteria for depression, the severity of which was determined by scores gained in Beck Depression Inventory and Hamilton Rating Scale for Depression (HAMD) questionnaires. Patients with initial HAMD scores between 21 and 31 were randomized into three groups, one of which (group A: 31 patients) received two tablets daily of SHR-5 (340 mg/day), a second (group B: 29 patients) received two tablets twice per day of SHR-5 (680 mg/day), and a third (group C: 29 patients) received two placebo tablets daily. The efficacy of SHR-5 extract with respect to depressive complaints was assessed on days 0 and 42 of the study period from total and specific subgroup HAMD scores. For individuals in groups A and B, overall depression, together with insomnia, emotional instability and somatization, but not self-esteem, improved significantly following medication, whilst the placebo group did not show such improvements. No serious side-effects were reported in any of the groups A-C. It is concluded that the standardized extract SHR-5 shows anti-depressive potency in patients with mild to moderate depression when administered in dosages of either 340 or 680 mg/day over a 6-week period.

Inhibitory effect of andrographolide from Andrographis paniculata on PAF-induced platelet aggregation.

Andrographolide, an active principle of the Chinese drug Andrographis paniculata, used for prevention and treatment of common cold in Scandinavia and known as an antiinflammatory, antiviral, antithrombotic, hypotensive and antiatherosclerotic drug, was investigated for its suggested influence on the biosynthesis of eicosanoids and the platelet-activating factor (PAF). Whereas in isolated human polymorph-nuclear leukocytes (PMNL) no influence on the biosynthesis was found, it could be shown that andrographolide inhibits PAF-induced human blood platelet aggregation in a dose dependent manner (IC50-5 microM). These results indicate that andrographolide has a mechanism of action different from that of non-steroidal antiinflammatory drugs (NSAID) and most likely associated with the cardiovascular and antithrombotic activity described of Andrographis paniculata.

Pharmacological activity of phenylpropanoids of the mistletoe, Viscum album L., host: Pyrus caucasica Fed.

Although a great number of compounds have been isolated from Viscum album (mistletoe, Viscaceae), none of them could be clearly shown to possess the established hypotensive, vasodilator, cardiotonic and antitumor activity of alcoholic preparations. In the course of our investigation of Armenian mistletoe Viscum album, host: Pyrus caucasica, which has been used in Armenian traditional medicine for the treatment of cardiovascular diseases and for stimulation of the immune system, four phenylpropanoid glycosides were isolated from EtOH-extract: coniferyl alcohol 4-O-ß-D-glucopyranoside (coniferin), syringenin 4-O-ß-D-glucopyranoside (syringin), and coniferylalcohol- and syringenin 4-O-ß-D-apiofuranosyl (1→2)-ß-D-glucopyranosides. The structures were established on the basis of the spectral and chemical data. All substances inhibited ADP-induced platelet aggregation, and the apiosyldiglycosides only inhibited leukotriene B4 release from TPA and calcium ionophore A-23187 stimulated human granulocytes. It is suggested that an antitumoral effect of ethanolic extract of Viscum album could be associated with the inhibition of protein kinase C (PKC).

On the adrenergic mechanism of cerebrovascular resistance regulation.

It has been found out experimentally that there is a decrease in the pressor action of noradrenaline on cerebral vessels during repeated injections, which is probably due to the increased concentration of endogenic prostaglandins in response to noradrenaline administration. During inhibition of prostaglandin biosynthesis we have observed reverse action -- increase in noradrenaline pressor action and sympathetic effect on cerebral vessels. The hypothetic scheme of prostaglandin participation in adrenergic regulation of cerebrovascular tone is presented.