scholarly journals Effects of Lactobacillus plantarum and Lactobacillus paracasei on the Peripheral Immune Response in Children with Celiac Disease Autoimmunity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1925 ◽  
Author(s):  
Åsa Håkansson ◽  
Carin Andrén Aronsson ◽  
Charlotte Brundin ◽  
Elin Oscarsson ◽  
Göran Molin ◽  
...  
Keyword(s):  
Immune Response ◽  
Celiac Disease ◽  
Placebo Group ◽  
Inflammatory Responses ◽  
Tissue Transglutaminase ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Th Cells ◽  
Double Blind Placebo ◽  
Peripheral Immune Response

Two Lactobacillus strains have proven anti-inflammatory properties by reducing pro-inflammatory responses to antigens. This randomized double-blind placebo-controlled trial tested the hypothesis that L. plantarum HEAL9 and L. paracasei 8700:2 suppress ongoing celiac disease autoimmunity in genetically at risk children on a gluten-containing diet in a longitudinally screening study for celiac disease. Seventy-eight children with celiac disease autoimmunity participated of whom 40 received 1010 CFU/day of L. plantarum HEAL9 and L. paracasei 8700:2 (probiotic group) and 38 children maltodextrin (placebo group) for six months. Blood samples were drawn at zero, three and six months and phenotyping of peripheral blood lymphocytes and IgA and IgG autoantibodies against tissue transglutaminase (tTG) were measured. In the placebo group, naïve CD45RA+ Th cells decreased (p = 0.002) whereas effector and memory CD45RO+ Th cells increased (p = 0.003). In contrast, populations of cells expressing CD4+CD25highCD45RO+CCR4+ increased in the placebo group (p = 0.001). Changes between the groups were observed for NK cells (p = 0.038) and NKT cells (p = 0.008). Median levels of IgA-tTG decreased more significantly over time in the probiotic (p = 0.013) than in the placebo (p = 0.043) group whereas the opposite was true for IgG-tTG (p = 0.062 respective p = 0.008). In conclusion, daily oral administration of L. plantarum HEAL9 and L. paracasei 8700:2 modulate the peripheral immune response in children with celiac disease autoimmunity.

scholarly journals Effects of perioperative intravenous ω-3 fatty acids in colon cancer patients: a randomized, double-blind, placebo-controlled clinical trial

2019 ◽  
Vol 111 (2) ◽  
pp. 385-395 ◽  
Author(s):  
Nathalie Bakker ◽  
Rick S van den Helder ◽  
Eline Stoutjesdijk ◽  
Johannes van Pelt ◽  
Alexander P J Houdijk
Keyword(s):  
Clinical Trial ◽  
Colon Cancer ◽  
Inflammatory Responses ◽  
Primary Anastomosis ◽  
Infectious Complications ◽  
Saline Control ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pufa Group

ABSTRACT Background The postoperative inflammatory response contributes to tissue healing and recovery but overwhelming inflammation is associated with postoperative complications. n–3 (ω-3) PUFAs modulate inflammatory responses and may help to prevent a proinflammatory cascade. Objectives We aimed to investigate the effects of perioperative intravenous n–3 PUFAs on inflammatory cytokines in colon cancer surgery. Methods This study is a randomized, double-blind, placebo-controlled clinical trial. Forty-four patients undergoing elective colon resection for nonmetastasized cancer were randomly assigned to 2 intravenous n–3 PUFA or saline control infusions the night before and the morning after surgery. Blood was sampled at 6 perioperative time points for changes in cytokines in serum and in LPS-stimulated whole blood samples and leukocyte membrane fatty acid profiles. Results Twenty-three patients received saline and 21 patients received n–3 PUFAs. Patient and operation characteristics were equal between groups, except for open resection (saline n = 5 compared with n–3 PUFA n = 0, P = 0.056). Ex-vivo IL-6 after LPS stimulation was significantly higher in the n–3 PUFA group at the first day after surgery (P = 0.014), but not different at the second day after surgery (P = 0.467). White blood cell count was higher in the n–3 PUFA group at the fourth day after surgery (P = 0.029). There were more patients with infectious complications in the n–3 PUFA group (8 compared with 3, P = 0.036). There were no overall differences in serum IL-6, IL-10, C-reactive protein, and length of stay. The administration of n–3 PUFAs resulted in rapid increases in leukocyte membrane n–3 PUFA content. Conclusions In the n–3 PUFA group a clear relation with serum and LPS-stimulated cytokines was not found but, unexpectedly, more infectious complications occurred. Caution is thus required with the off-label use of a perioperative intravenous n–3 PUFA emulsion as a standalone infusion in the time sequence reported in the present study in colon resections with primary anastomosis. This trial was registered at clinicaltrials.gov as NCT02231203.

scholarly journals Effect of Phytosomal Curcumin on Circulating Levels of Adiponectin and Leptin in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2019 ◽  
Vol 28 ◽  
pp. 183-189 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Azam Rezaei Farimani ◽  
Maryam Dehhabe ◽  
Mohammad Bidkhori ◽  
Mitra Hariri ◽  
...  
Keyword(s):  
Placebo Group ◽  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Serum Adiponectin ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Alcoholic Fatty Liver ◽  
Double Blind Placebo ◽  
Alcoholic Fatty Liver Disease

Background & Aims: Non-alcoholic fatty liver disease (NAFLD) is associated with insulin resistance and changes in serum adipocytokine levels. The aim of the current study was to evaluate the effect of phytosomal curcumin on serum adiponectin and leptin levels in patients with NAFLD. Methods: In this randomized double-blind, placebo-controlled trial, 65 eligible patients were randomly allocated into curcumin and placebo recipient groups using a blocked randomized technique. Parameters of weight, height, body mass index (BMI), fasting blood sugar (FBS), lipid profile, aspartate aminotransferase (AST), alanine aminotransferase (ALT), adiponectin, leptin, and the leptin:adiponectin ratio were measured at baseline and eight weeks after intervention. Results: High-density lipoprotein cholesterol (HDL-C) levels increased significantly in the curcumin group compared to the placebo group (p=0.01). Serum adiponectin levels increased significantly (p<0.001) and serum leptin levels decreased significantly (p<0.001) with a decrease in the leptin: adiponectin ratio in the curcumin group compared to the placebo group after 8 weeks of intervention. Conclusions: Non-alcoholic fatty liver disease was associated with changes in serum adipokines levels. Phytosomal curcumin effectively improved leptin and adiponectin levels. It is possible that curcumin efficacy will increase with long-term use of higher doses of this substance.

Evaluation of a nutritional supplement for the alleviation of pain associated with feline degenerative joint disease: a prospective, randomized, stratified, double-blind, placebo-controlled clinical trial

2021 ◽  
pp. 1098612X2110534
Author(s):  
Rachael Cunningham ◽  
Margaret E Gruen ◽  
Andrea Thomson ◽  
B Duncan X Lascelles
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Chondroitin Sulfate ◽  
Outcome Measures ◽  
Nutritional Supplement ◽  
Degenerative Joint Disease ◽  
Joint Disease ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo

Objectives The purpose of this study was to evaluate the pain-alleviating and activity-enhancing effects of glucosamine/chondroitin sulfate (Dasuquin) in cats that had degenerative joint disease (DJD) and owner-noted mobility/activity impairment. We hypothesized that the nutritional supplement would produce pain-relieving and activity-enhancing effects in cats with painful DJD. Methods In this prospective, randomized, stratified, double-blind, placebo-controlled clinical trial, 59 cats with DJD pain were assigned to receive a placebo (n = 30) or supplement (n = 29) for 6 weeks after 2 weeks of placebo. Outcome measures (at-home accelerometry and client-specific outcome measures [feline (CSOMf); Feline Musculoskeletal Pain Index (FMPI); quality of life (QoL)]; and veterinarian examination) were collected at days 14, 28, 42 and 56. Results Twenty-seven cats in the treatment group and 30 in the placebo group completed the trial. Within the first 2 weeks (placebo administration to all cats), 78% of all cats had an improvement in CSOMf scores. Both groups showed significant improvement at most time points in CSOMf, FMPI, QoL and pain scores, with the placebo group showing greater improvement than the supplement group (significant for CSOMf [ P = 0.01]). Overall, no differences in activity were seen between the groups. Cumulative distribution function analysis indicated that for most levels of activity, the placebo-treated cats were more active; however, the least active cats were more active on the supplement ( P = 0.013). Conclusions and relevance This study showed a strong placebo effect. The glucosamine/chondroitin sulfate supplement did not show pain-relieving effects when compared with placebo.

scholarly journals A Clinical Trial to Investigate the Effect of Cynatine HNS on Hair and Nail Parameters

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Christina Beer ◽  
Simon Wood ◽  
Robert H. Veghte
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Amino Acid ◽  
Hair Loss ◽  
Hair Growth ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
End Points ◽  
Double Blind Placebo ◽  
New Novel

Objective. A new, novel product, Cynatine HNS, was evaluated for its effects as a supplement for improving various aspects of hair and nails in a randomized, double-blind, placebo-controlled clinical trial.Methods. A total of 50 females were included and randomized into two groups. The active group (n=25) received 2 capsules containing Cynatine HNS, comprised of Cynatine brand keratin (500 mg) plus vitamins and minerals, per day, and the placebo group (n=25) received 2 identical capsules of maltodextrin per day for 90 days. End points for hair loss, hair growth, hair strength, amino acid composition, and hair luster were measured. End points were also measured for nail strength and the appearance of nails.Results. The results show that subjects taking Cynatine HNS showed statistically significant improvements in their hair and nails when compared to placebo.Conclusion. Cynatine HNS is an effective supplement for improving hair and nails in 90 days or less. EudraCT number is 2014-002645-22.

scholarly journals Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Lei Shen ◽  
Si Ra Gwak ◽  
Jong Cheon Joo ◽  
Bong Keun Song ◽  
Seon Woo Cha ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Panax Ginseng ◽  
Hepatic Dysfunction ◽  
Controlled Clinical Trial ◽  
Gamma Glutamyl Transferase ◽  
Double Blind ◽  
Ginseng Extract ◽  
Double Blind Placebo ◽  
Glutamyl Transferase

Background. The purpose of this study was to evaluate the efficacy and safety of Panax ginseng extract (GS-KG9) in the treatment of hepatic dysfunction. Methods. A randomized, double-blind, placebo-controlled clinical trial was conducted from December 2017 to January 2019. The trial included 60 subjects between the ages of 19 and 70 who had higher alanine transaminase (ALT) levels than the normal upper limit. The subjects were randomly divided into two groups: GS-KG9 (n = 30) and placebo (n = 30). The former was administered three GS-KG9 capsules (3 g/day) and the latter three placebo capsules (3 g/day) twice each day orally after meals in the morning and evening for 12 weeks. The primary goal was to observe the changes in ALT and gamma-glutamyl transferase (GGT) levels. The safety of the treatment was assessed and adverse events (AEs) were recorded. Results. Out of 60 subjects, nine were excluded from the efficacy analysis because they met the exclusion criteria. Therefore, a total of 51 subjects were evaluated for the effectiveness of the treatment (26 in the GS-KG9 group and 25 in the placebo group). After 12 weeks of treatment, the ALT levels were significantly reduced in the GS-KG9 group compared to the placebo group (p=0.009). The GGT level of the GS-KG9 group was significantly lower than that of the placebo group (p=0.036). Mild AEs, such as diarrhea, occurred during the study. There were no significant differences between the two groups. Conclusion. The results of this trial suggest that GS-KG9 might be an effective and safe option for mild hepatic dysfunction. This trial is registered with KCT0004080.

Double blind placebo controlled clinical trial of homoeopathic medicines in HIV infection

1998 ◽  
Vol 87 (02) ◽  
pp. 86-88 ◽  
Author(s):  
DP Rastogi ◽  
VP Singh ◽  
Vikram Singh ◽  
SK Dey ◽  
K Rao
Keyword(s):  
Placebo Group ◽  
T Cell ◽  
Hiv Infection ◽  
Cd4 T Cell ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cell Numbers ◽  
Significant Difference ◽  
Hiv Aids

AbstractA 6 month study comprising of a Double-blind Placebo-controlled trial of homoeopathic medicines in HIV/AIDS under 2 separate schemes (I) Asymptomatic HIV infection and (II) Persistent generalised lymphadenopathy (50 subjects each) was undertaken from June 1995 to February 1997. As soon as a subject had undergone 6 months of study, they were put on an indicated medicine. Unblinding of the schemes was done only when the last subject had undergone 6 months of study. Changes in the CD4+ T cell numbers in each case before, during and after completion of the study, was taken as the main criterion to assess the outcome of the treatment. Preliminary studies in Scheme I after unblinding, show practically no significant difference in changes in number of CD4+ T cells in subjects of both the placebo and the medicine group. Studies in Scheme II after unblinding, show a significant improvement in CD4+ cell numbers (Upward trend) in the subjects of the medicine group compared to the placebo group. Significantly, after 6 months of study, 5 subjects of the placebo group under Scheme II and 4 from Scheme I with an initial downward trend of CD4+ T cell, have shown an increase in CD4+ T cell count after administration of the indicated homoeopathic medicine in a period of 15–30 days. The study confirms a positive role of homoeopathic medicines in improving immune status of HIV/AIDS patients.

scholarly journals A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Effects of Angelica Gigas Nakai Extract on Blood Triglycerides

Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 377
Author(s):  
Su-Jin Jung ◽  
Woo-Rim Kim ◽  
Mi-Ra Oh ◽  
Youn-Soo Cha ◽  
Byung-Hyun Park ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Density Lipoprotein ◽  
Atherogenic Index ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Angelica Gigas ◽  
Double Blind Placebo ◽  
Angelica Gigas Nakai

Angelica gigas Nakai, Korean dang-gui, has long been widely used in traditional treatment methods. There have been a number of studies of the health effects of A. gigas and related compounds, but studies addressing effects on blood triglycerides (TG) are lacking. To investigate the effects of A. gigas Nakai extract (AGNE) on TG in Korean subjects, we carried out a 12-week, randomized, double-blind, placebo-controlled clinical trial. Subjects who met the inclusion criterion (130 mg/dL ≤ fasting blood TG ≤ 200 mg/dL) were recruited for this study. One hundred subjects were assigned to the AGNE group (n = 50) or the placebo group (n = 50), who were given 1 g/day of AGNE (as a gigas Nakai extract 200 mg/d) in capsules and the control group for 12 weeks. Outcomes were efficacy TG, lipid profiles, atherogenic index, and safety parameters were assessed initially for a baseline measurement and after 12 weeks. After 12 weeks of supplementation, TG and very low-density lipoprotein cholesterol (VLDL-C) concentration and TG/HDL-C ratio in the AGNE group were significantly reduced compared to the placebo group (p < 05). No significant changes in any safety parameter were observed. These results suggest that the ingestion of AGNE may improve TG and be useful to manage or prevent hypertriglyceridemia.

Efficacy of Khār-i-khasak (Tribulus terrestris Linn.) in prehypertension: a randomized, double-blind, placebo-controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mansoor Ahmad Siddiqui ◽  
Malik Itrat ◽  
Abdul Mobeen ◽  
Md Imran Khan
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Diastolic Blood Pressure ◽  
Controlled Trial ◽  
Test Group ◽  
Controlled Clinical Trial ◽  
Tribulus Terrestris ◽  
Blood Pressure Lowering Effect ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background Prehypertension is a state of above-normal blood pressure that does not meet the criteria for the diagnosis of hypertension and its prevalence estimated in population-based samples ranges from 22 to 52%. It conveys potentially many deleterious consequences such as high risk of progression to hypertension and cardiovascular disease later in life. Objectives The present study was conducted to evaluate the blood pressure-lowering effect of Khār-i-khasak (Tribulus terrestris Linn.) in prehypertensive individuals. Methods This randomized, double-blind, placebo-controlled, clinical trial was conducted at the National Institute of Unani Medicine, Hospital, Bengaluru, after approval by the Institutional Ethics Committee. Prehypertensive individuals over 18 years of age were enrolled after obtaining their written informed consent and were randomly allocated to the test or placebo group. The test and placebo groups were administered powdered dried fruits of Khār-i-khasak (6g) and matched placebo (6g) in three divided doses for two months respectively. The efficacy assessment was determined by changes in systolic and diastolic blood pressures. Results Both systolic and diastolic blood pressure showed a significant decline in the test group (p<0.001) as compared to the placebo group. The average decline in systolic/diastolic blood pressure was −7.7/5.5 mmHg in the test group and −1.9/0.2 mmHg in the placebo group. During the post-therapy follow-up period, no prehypertensive developed full-blown hypertension in either group. Safety parameters were found to be within normal limits. Conclusions The test drug Khār-i-khasak (T. terrestris Linn.) was found to be effective and safe in lowering blood pressure compared to placebo in prehypertensive individuals.

Pregabalin augmentation for resistant obsessive–compulsive disorder: a double-blind placebo-controlled clinical trial

CNS Spectrums ◽  
2019 ◽  
Vol 25 (4) ◽  
pp. 552-556
Author(s):  
Arash Mowla ◽  
Mehrnoosh Ghaedsharaf
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Obsessive Compulsive Disorder ◽  
Controlled Clinical Trial ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Good Tolerability ◽  
Double Blind Placebo ◽  
Compulsive Disorder ◽  
Current Medication

AbstractBackground and objective.Glutamate dysfunction has been shown to be associated with pathophysiology of obsessive–compulsive disorder (OCD). Our objective is to survey the effects of pregabalin (a glutamate-modulating agent) as an augmenting treatment for resistant OCD.Patients and methods.In this 12-week double-blind placebo-controlled clinical trial, 56 patients with resistant OCD were randomly allocated to receive either pregabalin or placebo plus their current medication (sertraline). Yale–Brown Obsessive Compulsive Scale (Y-BOCS) was used to evaluate the outcomes. Adverse effects were also registered.Results.Of the 56 patients with resistant OCD who were randomly allocated in 2 groups of pregabalin (n = 28) and placebo group (n = 28), 42 patients (22 in pregabalin group and 20 in placebo group) completed the trial. Throughout the trial, the mean score decreased from 26.13± 7.03 to 8.81 ± 3.47 in the pregabalin group (p < 0) and from 26.85 ± 4.34 to 17.63 ± 4.22 in the placebo group (p < 0). At the end of trial, 16 (57.14%) patients in the pregabalin group and 2 (7.14%) patients in the placebo group showed more than 35% decline in YBOCS (p < .01). The pregabalin group showed good tolerability and safety.Conclusions.Our study revealed that pregabalin, as an augmenting medication, is more effective than placebo in the treatment of patients with resistant OCD.

scholarly journals Intravenous Tenoxicam for Analgesia following Laparoscopic Cholecystectomy

1998 ◽  
Vol 26 (1) ◽  
pp. 56-60 ◽  
Author(s):  
F. J. Munro ◽  
S. J. Young ◽  
I. J. Broome ◽  
H. M. Robb ◽  
G. J. Wardall
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Cholecystectomy ◽  
Placebo Group ◽  
Adverse Effects ◽  
Controlled Clinical Trial ◽  
Patient Controlled Analgesia ◽  
Double Blind ◽  
Rescue Analgesia ◽  
Double Blind Placebo ◽  
Pain Scores

In a double-blind, placebo-controlled clinical trial (power of 80% to detect a 30% reduction in morphine consumption, P<0.05) we have determined that intraoperative intravenous administration of tenoxicam 40 mg during laparoscopic cholecystectomy, when compared with placebo, was associated with a significant reduction in consumption of morphine at 6 hours and 12 hours (P<0.05) but not at 24 hours, when assessed by patient-controlled analgesia. Furthermore there was a significantly greater requirement for “rescue” analgesia with intramuscular morphine in the placebo group during the period of the study. There was no difference between the groups in pain scores, either at rest or on movement, nor in the incidence of nausea and vomiting. No patient in either group suffered a respiratory rate less than 8/min or oversedation at any time, and there were no other adverse effects.

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