METHODS: This multicenter randomized double-blind placebo-controlled phase 2 trial included 110 solid malignant tumor patients (stage II-IV) undergoing chemotherapy. They were randomly selected and provided oral Nuvastatic™ 1000 mg (N = 56) or placebo (N = 54) thrice daily for 9 weeks. The primary outcomes were fatigue (Brief Fatigue Inventory (BFI)) and Visual Analog Scale for Fatigue (VAS-F)) scores measured before and after intervention at baseline and weeks 3, 6, and 9. The secondary outcomes were mean group difference in the vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36) and urinary F2-isoprostane concentration (an oxidative stress biomarker), Eastern Cooperative Oncology Group scores, adverse events, and biochemical and hematologic parameters. Analysis was performed by intention-to-treat (ITT). Primary and secondary outcomes were assessed by two-way repeated-measures analysis of variance (mixed ANOVA).
RESULTS: The Nuvastatic™ group exhibited an overall decreased fatigue score compared with the placebo group. Compared with the placebo group, the Nuvastatic™ group significantly reduced BFI-fatigue (BFI fatigue score, F (1.4, 147) = 16.554, p
MATERIALS AND METHODS: The oral toxicity study using Swiss albino mice was performed in accordance with OECD guidelines. The EtAI and AqAI extracts of Aristolochia indica Linn were studied for antidiarrhoeal property using castor oil-induced diarrhoeal model and charcoal-induced gastrointestinal motility test in Swiss albino mice.
RESULTS: Among the tested doses of 200 and 400 mg/kg body weight, the extracts reduced the frequency and severity of diarrhoea in test animals throughout the study period. At the same doses, the extract delayed the intestinal transit of charcoal meal in test animals as compared to the control and the results were statistically significant.
CONCLUSION: Experimental findings showed that ethanol extract of Aristolochia indica Linn root possess significant antidiarrheal activity and may be a potent source of anti-diarrhoeal drug in future.
MATERIALS AND METHODS: Antinociceptive activity of ethanol pomegranate extract was examined using three models of pain: the writhing test, the hot tail flick test and the plantar test. The ethanolic extract of pomegranate was administered by oral gavages in doses of (100,150 and 200mg/kg, p.o (orally)), for all the tests and compared with aspirin (100mg/kg, p.o.) which was considered as the standard drug. Phytochemical screening and HPLC analysis of the plant species was carried out.
RESULTS: In the writhing test, the index of pain inhibition (IPI) was 37% for ethanolic extract of pomegranate (200mg/kg, p.o.), and 59% for aspirin. In the hot tail flick test, the ethanolic extract of pomegranate (200mg/kg, p.o.), has shown significant analgesia reaching its peak at 60 min maximum possible analgesia (MPA), was 24.1% as compared with aspirin 37.5%. Hyperalgesia was successfully induced by the plantar test and the ethanol extract of pomegranate (100,150,200mg/kg, p.o.), reduced the hyperalgesia in a dose dependent manner comparable to aspirin at (100mg/kg, p.o.). HPLC analysis revealed the presence of gallic acid, ellagic acid and Punicalagins A&B.
CONCLUSION: The results demonstrated that ethanol pomegranate extract has an antinociceptive effect that may be related to the presence of identified phytochemicals.
METHODS: Galactagogue activity was evaluated in terms of quantity of milk produced from the rats treated with petroleum ether, ethanol or water extracts of the flower. Lactating rats (n = 5) of Spraque Dawley with six pups each were administered with the extracts in the amount of 500 mg/kg body weight, while the control rats were given an equivalent amount of distilled water. The rats were daily administered via oral feeding starting from Day 5 until Day 14 and the performance of milk production was measured along the experimental period by weight-suckle-weight method. Results were statistically analyzed using SPSS by means of ANOVA at 0.05 and was expressed as their mean?standard deviation. The rates of pups' growth were measured as the weight gain along the experimental period.
RESULTS: The rats treated with aqueous extract produced higher milk than control and ethanol groups. Aqueous extract was identified to increase milk production by 25%, while petroleum ether extract by 18%. The mean of yields produced by the rats during suckling period for aqueous, petroleum ether, ethanol and control were 4.62±2.45, 4.37±1.93, 3.65±1.89 and 3.69±1.79, respectively. Growth rates of pups for the rats treated with control, aqueous, ethanol extract and petroleum ether were (1.85±0.49), (1.78±0.56), (1.65±0.46) and (1.56±0.42) g/pup, respectively.
CONCLUSIONS: The present study reveals the potential of M. x paradisiaca flower to enhance milk production of nursing mothers which could be exploited for commercialization of the isolated extract.
AIM OF THE STUDY: To assess the in vitro mutagenicity and in vivo genotoxicity of aqueous extract of V. officinalis leaves using a modified Ames test and rat bone marrow micronucleus assay according to OECD guidelines.
MATERIALS AND METHODS: In vitro Ames test was carried out using different strains of Salmonella (TA97a, TA98, TA100, and TA1535) and Escherichia coli WP2 uvrA (pKM101) in the presence or absence of metabolic activation (S9 mixture). For micronucleus experiment, male and female Sprague-Dawley rats (n = 6/group) were received a single oral daily dose of 500, 1000, and 2000 mg/kg of V. officinalis extract for three days. Negative and positive control rats were received distilled water or a single intraperitoneal injection of 50 mg/kg of cyclophosphamide, respectively. Following dissection, femurs were collected and bone marrow cells were stained with May-Grünwald-Giemsa solution for micronucleus assessment.
RESULTS: Ames test results demonstrated that 5, 2.5, 1.25 and 0.625 mg/ml of V. officinalis extract induced a significant mutagenic effect against TA100 and TA98 strains (with and without metabolic activation). Findings of the animal study showed there were no significant increase in the micronucleated polychromatic erythrocytes (MNPE) and no significant alterations in the polychromatic erythrocytes (PCE) to normochromatic erythrocytes (NCE) ratio of treated rats as compared with their negative control. Meanwhile, significantly increased in the MNPEs was seen in the cyclophosphamide-treated group only.
CONCLUSION: Aqueous extract of V. officinalis has mutagenic effect against TA98 and TA100 strains as demonstrated by Ames test, however, there is no in vivo clastogenic and myelotoxic effect on bone marrow micronucleus of rats indicating that the benefits of using V. officinalis in traditional practice should outweigh risks.
AIM OF THE STUDY: Since kratom is reported to deform sperm morphology and reduce sperm motility, we aimed to clinically investigate the testosterone levels following long-term kratom tea/juice use in regular kratom users.
METHODS: A total of 19 regular kratom users were recruited for this cross-sectional study. A full-blood test was conducted including determination of testosterone level, follicle stimulating hormone (FSH) and luteinizing hormone (LH) profile, as well as hematological and biochemical parameters of participants.
RESULTS: We found long-term kratom tea/juice consumption with a daily mitragynine dose of 76.23-94.15 mg did not impair testosterone levels, or gonadotrophins, hematological and biochemical parameters in regular kratom users.
CONCLUSION: Regular kratom tea/juice consumption over prolonged periods (>2 years) was not associated with testosterone impairing effects in humans.
METHODS: Eight cyclists exercised at three submaximal intensities before completing a TTE100% at sea-level (SEA) and at 1657 m of altitude (ALT), with pre-exercise consumption of 1000 mg of POMx or a placebo (PLAC) in a randomized, double-blind, crossover design. Data were analysed using a three way (treatment x altitude x intensity) or two-way (treatment x altitude) repeated measures ANOVA with a Fisher's LSD post-hoc analysis. Significance was set at p ≤ 0.05. The effect size of significant interactions was calculated using Cohen's d.
RESULTS: TTE100% performance was reduced in ALT but was not influenced by POMx (p > 0.05). Plasma NO3- were 10.3 μmol greater with POMx vs. PLAC (95% CI, 0.8, 19.7,F1,7 = 7.83, p 0.05). Submaximal VO2 values were not affected by POMx (p ≥ 0.05).
CONCLUSIONS: The restoration of SEA VO2 values at ALT is likely driven by the high polyphenol content of POMx, which is proposed to improve nitric oxide bioavailability. Despite an increase in VO2, no change in exercise performance occurred and therefore this study does not support the use of POMx as an ergogenic supplement.
METHODS: PubMed, LILACS and Google Scholar were searched for randomized or non-randomized trials enrolling patients with suspected or confirmed dengue where CP extract was compared, as a treatment measure, against standard treatment. Recovery of platelet counts as well as other clinical indicators of favourable outcome (duration of hospital stay, prevention of plasma leakage, life threatening complications, and mortality) were assessed.
RESULTS: Nine studies (India-6, Pakistan-1, Indonesia-1, Malaysia-1) met the inclusion criteria. Seven studies showed an increase in platelet counts in patients receiving CP extract, while one study showed no significant difference between the two groups, and direct comparison was not possible in the remaining study. Serious adverse events were not reported. CP extract may reduce the duration of hospital stay (mean difference - 1.98 days, 95% confidence interval - 1.83 to - 2.12, 3 studies, 580 participants, low quality evidence), and cause improvement in mean platelet counts between the first and fifth day of treatment (mean difference 35.45, 95% confidence interval 23.74 to 47.15, 3 studies, 129 participants, low quality evidence). No evidence was available regarding other clinical outcomes.
CONCLUSIONS: The clinical value of improvement in platelet count or early discharge is unclear in the absence of more robust indicators of favourable clinical outcome. Current evidence is insufficient to comment on the role of CP extract in dengue. There is a need for further well designed clinical trials examining the effect of CP on platelet counts, plasma leakage, other serious manifestations of dengue, and mortality, with clearly defined outcome measures.