Safety evaluation of an antimalarial herbal product from Andrographis paniculata (AS201-01) in healthy volunteers

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Aty Widyawaruyanti ◽  
Arijanto Jonosewojo ◽  
Hilkatul Ilmi ◽  
Lidya Tumewu ◽  
Ario Imandiri ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Healthy Volunteers ◽  
Day Treatment ◽  
Phase 1 ◽  
Andrographis Paniculata ◽  
Control Group ◽  
Healthy Human ◽  
Double Blind ◽  
Random Blood Glucose ◽  
Significant Difference

Abstract Objectives Andrographis paniculata tablets (AS201-01) have previously been shown to have potent bioactivity as an antimalarial and to produce no unwanted side effects in animal models. Here, we present the phase 1 clinical trial conducted to evaluate the safety of AS201-01 tablets in healthy volunteers. Methods The study was a randomized, double-blind controlled cross-over, a placebo-controlled design consisting of a 4-day treatment of AS201-01 tablets. A total of 30 healthy human volunteers (16 males and 14 females) were divided into two groups, and each group was given 4 tablets, twice daily for 4 days. Group 1 received AS201-01, while group 2 received placebo tablets. Volunteers were given a physical examination before the treatment. The effects of AS201-01 on random blood glucose, biochemical, and hematological as well as urine profiles were investigated. Results There were no changes in observed parameters as a result of AS201-01 being administered. Statistical analysis showed no significant difference (p>0.05) between the test and control group regarding hematology profile, biochemical profile, and random blood glucose. Increased appetite and better sleep, which categorized as grade 1 adverse event was reported after treatment with AS201-01 tablet Conclusions The outcome supports our previous observation that the AS201-01 tablet, given twice a day for 4 days, is safe and nontoxic.

A study using Sepia 200c given prophylactically postpartum to prevent anoestrus problems in the dairy cow

1991 ◽  
Vol 80 (03) ◽  
pp. 149-156 ◽  
Author(s):  
A.V. Williamson ◽  
W.J. Crawford ◽  
B. Rennie ◽  
W.L. Mackie
Keyword(s):  
Reproductive Performance ◽  
Day Treatment ◽  
Control Group ◽  
Double Blind ◽  
Service Period ◽  
Significant Difference ◽  
Placebo Trial ◽  
The Mean ◽  
And Control ◽  
Action List

AbstractThe results obtained from a study model using Sepia 200c in a herd of dairy cows led to an extended study. Overall reproductive performance was monitored monthly by a farm action list and the technique of palpation of the ovaries per rectum was used to determine pregnancy and cyclical status. A total of 101 cows were randomly treated with Sepia 200c on day 14 or 21 postpartum.Statistical analysis of the results was based on the differences between the untreated Control and Sepia-treated groups in periparturient disorders and pre- and post-service periods, and between the two Sepia-treated groups.In the pre-service period, a significant difference was found between the sepia-treated groups in the proportion of heifers calved, the number of assisted calvings and pre-service problems compared to Control. A difference of 9.9 total mean days to oestrus post-treatment was found between the Sepia-treated groups.During the post-service period, significant differences were found in the conception rate to first service, the percentage of cows in calf and total culled.A reduction (non significant) was found in the 21-day treatment group compared to control and 14-day treatment in the mean days calving to conception interval and the calving index. However, between the Sepia-treated groups a significant difference was found in total mean days calving to conception interval.The results of this study appear to demonstrate a difference in effect between the Sepia-treated groups and Control group. The study has been extended into a double blind placebo trial to find the effect of using a placebo and assess the use of Sepia given earlier postpartum on herd reproductive performance.

scholarly journals Daily supplementation of tocotrienol-rich fraction or α-tocopherol did not induce immunomodulatory changes in healthy human volunteers

2008 ◽  
Vol 101 (6) ◽  
pp. 810-815 ◽  
Author(s):  
Ammu K. Radhakrishnan ◽  
Ai-Ling Lee ◽  
Pak-Fong Wong ◽  
Jagmohni Kaur ◽  
Htin Aung ◽  
...  
Keyword(s):  
Vitamin E ◽  
Healthy Volunteers ◽  
Immune Modulation ◽  
Controlled Trial ◽  
Interferon Γ ◽  
Control Group ◽  
Plasma Vitamin ◽  
Healthy Human ◽  
Double Blind ◽  
Tocotrienol Rich Fraction

Vitamin E is divided into two subgroups; tocopherols and tocotrienols. Both have protective roles in biological systems. The present study was conducted to compare the effect of short-term supplementation at 200 mg/d of either α-tocopherol or a tocotrienol-rich fraction (TRF) from palm oil on immune modulation and plasma vitamin E levels in normal healthy Asian volunteers. In a randomised, double-blind placebo-controlled trial conducted, fifty-three healthy volunteers aged 20–50 years were recruited based on the study's inclusion and exclusion criteria. They were randomly assigned into three groups, i.e. two experimental groups that received daily supplementation at 200 mg of either α-tocopherol or the TRF, and the control group that received a placebo. Blood was drawn on days 0, 28 and 56 for several laboratory analyses. Differences in the production of IL-4 or interferon-γ by concanavalin A-stimulated lymphocytes isolated from these volunteers were not significant (P>0·05). There were no significant differences observed in immune parameters between the healthy volunteers who received daily supplementation with either α-tocopherol or the TRF. As these observations were made in the absence of any immunogenic challenge, we feel it would be of benefit to study if there would be any differences observed when an immunogenic challenge such as vaccination were introduced.

scholarly journals Efek konsumsi yogurt terhadap glukosa darah puasa pada penyandang diabetes melitus tipe 2

2020 ◽  
Vol 8 (1) ◽  
pp. 40
Author(s):  
Farah Nuriannisa ◽  
Nyoman Kertia ◽  
Lily Arsanti Lestari
Keyword(s):  
Blood Glucose ◽  
Controlled Trial ◽  
Health Centre ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Significant Difference ◽  
Before And After ◽  
Reduce Blood Glucose

Background: Generally, patients with type 2 diabetes mellitus (T2D) have dysbiosis condition. Dysbiosis can increase oxidative stress that leads to hyperglycemia. Previous researches showed that yogurt consumption can reduce blood glucose in T2D, so it can be used as an alternative healthy snack for T2D patients.Objectives: To investigate the effects of probiotic and conventional yogurt with dosage 100ml/day on fasting blood glucose (FBG) in T2D patientsMethods: Randomized controlled trial, double blind with pre-post group design. The 30 T2D patients from 3 publics health centre in Yogyakarta, were assigned to two groups. Each group, either control or intervention group, received 100 ml/d of yogurt for 4 weeks. FBG samples was assessed before and after intervention periodResults: FBG significantly decreased in both group, which was -27 mg/dL in control group (p<0.05) and -19 mg/dL in intervention group (p<0.05). No significant difference in FBG change between intervention and control group, but control group has greater reduction in FBG compared to intervention group. Conclusion: Conventional yogurt has no significant difference effect in FBG change compared to probiotic yogurt. 

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

Effect of insulin-induced hypoglycaemia on antral, pyloric and duodenal motility in fasting subjects

1991 ◽  
Vol 81 (2) ◽  
pp. 281-285 ◽  
Author(s):  
R. Fraser ◽  
J. Fuller ◽  
M. Horowitz ◽  
J. Dent
Keyword(s):  
Blood Glucose ◽  
Gastric Emptying ◽  
Phase I ◽  
Blood Glucose Concentration ◽  
Migrating Motor Complex ◽  
Control Group ◽  
Motor Complex ◽  
Significant Difference ◽  
Interdigestive Migrating Motor Complex ◽  
Pyloric Motility

1. Hyperglycaemia alters gastric motility and delays gastric emptying. By contrast, there is little information regarding the effect of sub-normal blood glucose concentrations on gastric and, in particular, pyloric motility, although limited data suggest that hypoglycaemia is associated with accelerated gastric emptying despite an apparently increased basal pyloric pressure. 2. To determine the effects of hypoglycaemia on pyloric motility, we compared the effects of an intravenous injection of insulin (0.15 units/kg) with those of a placebo injection of saline in eight healthy human volunteers during phase I of the interdigestive migrating motor complex. 3. All subjects developed profound hypoglycaemia (mean blood glucose concentration 1.6 mmol/l compared with 4.0 mmol/l in the control group). 4. There was no significant difference in the number of antral (9 versus 7, P = 0.34), pyloric (3 versus 0, P = 0.31) or duodenal (21 versus 13, P = 0.42) pressure waves or in the basal pyloric pressure (0.3 mmHg versus 0.1 mmHg, P = 0.37) in the 45 min after insulin injection (hypoglycaemia) when compared with the 45 min after saline injection (euglycaemia). In both the euglycaemic and hypoglycaemic studies there was a time-dependent increase in the numbers of antral and duodenal waves consistent with the expected changes in the interdigestive migrating motor complex. 5. These results indicate that insulin-induced hypoglycaemia has no significant effect on pyloric motility during phase I of the interdigestive migrating motor complex.

scholarly journals The post-lunch effect of regular and decaffeinated coffee on psychomotor performance: a randomized double-blind cross-over study

2021 ◽  
Vol 10 (8) ◽  
pp. 954
Author(s):  
Suganthi S. Ramachandran ◽  
Vijay L. Kumar ◽  
S. N. Dwivedi ◽  
Vishwajeet Singh ◽  
Pooja Gupta
Keyword(s):  
Healthy Volunteers ◽  
Psychomotor Performance ◽  
Subjective Ratings ◽  
Double Blind ◽  
Flicker Fusion Frequency ◽  
Female Ratio ◽  
Cardiovascular Parameters ◽  
Significant Difference ◽  
Decaffeinated Coffee ◽  
The Mean

Background: This study aimed to compare the effect of regular coffee and decaffeinated coffee on psychomotor performance in healthy volunteers during post-lunch period.Methods: In this randomized double-blind cross-over study, adult healthy volunteers were given hot coffee (3 g each of regular or decaffeinated coffee) during post-lunch period. Psychomotor functions (critical flicker-fusion frequency (CFF), choice reaction time (CRT) and error count in hand-steadiness test (HST)), blood pressure and heart rate were measured pre-lunch, pre-coffee (1-hour post-lunch) and 1-hour post-coffee consumption. Subjective ratings of sleepiness and mood were also assessed during post-lunch sessions.Results: The mean age of the participants (n=16) was 27.4±2.7 years with a male: female ratio of 7:9. There was no significant deterioration in psychomotor performance post-lunch when compared to pre-lunch on both the days. The mean CFF, CRT, errors committed in HST and cardiovascular parameters did not differ significantly between regular coffee and decaffeinated groups during post-lunch sessions. There was no significant difference in values of cardiovascular parameters as well as subjective ratings of sleep and mood between two groups.Conclusions: In healthy adult individuals’ consumption of both regular coffee and decaffeinated coffee during the post-lunch period did not affect psychomotor performance.

scholarly journals The Effect of Probiotics on Bacterial Pneumonia

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Ahmad Najafi ◽  
Alireza Sharif ◽  
Mohammadreza Sharif ◽  
Hamidreza Gilassi
Keyword(s):  
Bacterial Pneumonia ◽  
Treatment Protocol ◽  
Response To Treatment ◽  
Control Group ◽  
Case Group ◽  
Chi Square ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Mortality And Morbidity ◽  
Significant Difference

Background: Pneumonia, as a fairly prevalent illness, is the main cause of hospital mortality. The major cause of mortality and morbidity of pneumonia is due to bacteria. The presence of multi-drug resistant pathogens and no response to treatment have aroused considerable interest in the use of probiotic components to prevent infections. Objectives: Given that few studies have evaluated the efficacy of probiotics in reducing bacterial pneumonia, the current aimed to evaluate the role of probiotics in decreasing pneumonia. Methods: This double-blind, randomized clinical trial study was conducted on 100 patients diagnosed with bacterial pneumonia in Shahid Beheshti Hospital, Kashan, Iran, during 2018. Patients were randomly classified into two groups (n = 50). One group (case) received two sachets of probiotic/daily for five days, and another group (control) received placebo. Moreover, patients in both groups received the same treatment protocol. All data were extracted from medical records. Chi-square test and independent t-test were used for analysis of data. P < 0.05 was considered statistically significant. Results: No significant difference was seen between case and control groups regarding age, gender, and duration of symptoms before hospitalization (P > 0.05), which implies a completely random classification of two groups. The mean duration of hospitalization, dyspnea, tachypnea, cough, fever, and crackles was significantly decreased in the case group compared to the control group (P < 0.05). Conclusion: The use of probiotics can be effective in reducing the duration of dyspnea, tachypnea, cough, fever, and length of hospitalization. Therefore, probiotics may be considered a promising treatment for the development of new anti-infectious therapy. In addition, the usage of probiotics along with antibiotics is suggested for decreasing pneumonia complications and improving the efficacy of therapy.

scholarly journals Effectiveness of Preoperative Chlorhexidine Mouthwash on Pain After Lower Posterior Teeth Removal: A Randomized, Double-Blind Clinical Trial

2020 ◽  
Vol 12 (4) ◽  
pp. 112-119
Author(s):  
Abbas Haghighat ◽  
Shaqayeq Ramezanzade
Keyword(s):  
Control Group ◽  
Placebo Control ◽  
Study Group ◽  
Mouth Rinse ◽  
Pain Level ◽  
Double Blind ◽  
Posterior Teeth ◽  
Post Operative Pain ◽  
Double Blind Clinical Trial ◽  
Significant Difference

Background: Pain is one of the most common complications after tooth extraction and pain control is a crucial part of the procedure. The purpose of this study was to investigate the influence of 0.2% (w/v) chlorhexidine (CHX) gluconate mouth rinse on the severity of post-extraction pain. Methods: A prospective, randomized, double-blind trial was conducted among 170 subjects. Subjects were instructed to rinse with 15 mL of CHX mouth rinse (study group) or placebo (control group) 0.5 to 1 hour before extraction. Post-operative pain was evaluated considering the number of taken rescue analgesics and using a visual analog scale (VAS) that each case completed 6, 12, 24, and 48 hours after the surgery. The Mann-Whitney U test was performed in this regard. Results: There were no significant differences between the two groups regarding demographic variables (P>0.05). The preoperative use of CHX mouth rinse showed a better performance in mitigating the perceived pain. A significant difference in the pain level (P=0.001) was found only at the 6th hour postoperatively although there was no significant difference in the pain level between the two groups (P>0.05) at all other times (12th, 24th, 48th hours). The total number of analgesics that were taken by the study group was significantly lower compared to the control group (P=0.042). Conclusions: The preoperative CHX mouth rinse could be a beneficial choice for reducing pain after simple tooth extractions.

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