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, Randomized Clinical Trial of the Effect of the Dietary Supplement S-Adenosyl-L-Methionine (AdoMet) on Plasma Homocysteine (Hcy) Levels in Healthy Human Subjects.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 1481-1481
Author(s):  
Michael A. Thompson ◽  
Brent A. Bauer ◽  
Laura L. Loehrer ◽  
Stephen S. Cha ◽  
Jayawant N. Mandrekar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Randomized Clinical Trial ◽  
Primary Endpoint ◽  
Human Subjects ◽  
Nutritional Supplement ◽  
Healthy Human ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Healthy Human Subjects

Abstract BACKGROUND: S-adenosyl-L-methionine (AdoMet or SAM-e®) is a commonly used nutritional supplement available in the United States since 1999. AdoMet is metabolized to homocysteine (Hcy), a potential cardiovascular risk factor. A few open-label, single-arm studies have reported on the effect of exogenous AdoMet on the levels of Hcy in humans; however, this has not been tested in a double-blind, randomized clinical trial. As a nutritional supplement, AdoMet is subject only to limited regulation by the FDA, despite being used to treat clinical diseases such as depression and osteoarthritis. AdoMet is the methyl donor for small molecule, DNA, RNA, and protein methylation reactions; therefore, further understanding the biology of the AdoMet/Hcy system is important. We hypothesized that exogenous AdoMet would increase plasma Hcy levels. METHODS: In a double-blind, placebo-controlled, randomized clinical trial, 93 healthy human subjects were screened and 52 were treated with placebo (26) or 800 mg per day AdoMet (26) pills for 4 weeks. Pre- and post-treatment Hcy levels were measured. The primary endpoint was change in Hcy level. Secondary endpoints included an interim Hcy level, high sensitivity C-reactive protein (hsCRP) levels, lipid profile, and transaminases. Exclusion criteria included pregnancy and concurrent use of medications associated with changes in Hcy. RESULTS: Of 52 subjects enrolled, 45 were evaluable at the end of treatment. Subject characteristics and dropout rates were similar between placebo and control groups. Adverse events were minor and were not different between placebo and AdoMet. The primary endpoint, change in Hcy, was not significantly different between the groups (mean (umol/L), baseline: 7.43 (placebo), 8.25 (AdoMet), P=0.358; 4 week: 7.66 (placebo), 8.06 (AdoMet), P = 0.683; Baseline − 4 week: 0.23 (placebo), −0.19 (AdoMet), P = 0.427). No statistically significant difference in change in Hcy or hsCRP at 2 or 4 weeks was noted. This was true for both absolute differences as well as relative percent changes. A small decrease in ALT was observed at 2 weeks in the AdoMet group compared to the placebo group (P = 0.027). AdoMet is used in the treatment of liver diseases. There was a small, but statistically significant (P = 0.028) decrease in total cholesterol in the AdoMet group as compared to the placebo group. Interestingly, a subject with the highest baseline Hcy level had a decline in Hcy on AdoMet. Study limitations include no evaluation of AdoMet serum levels or measurement of the effect of AdoMet on DNA methylation patterns. CONCLUSIONS: AdoMet seems well tolerated and in a dose of 800 mg/day for 4 weeks does not appear to significantly affect Hcy levels in the blood. Future clinical trials of AdoMet should monitor Hcy levels with extended use of AdoMet to confirm its safety with long term use. Clinicaltrials.gov ID: NCT00284011.

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.

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.

scholarly journals Impact of a nutritional supplement (Impryl) on male fertility: study protocol of a multicentre, randomised, double-blind, placebo-controlled clinical trial (SUppleMent Male fERtility, SUMMER trial)

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e035069
Author(s):  
Roos Smits ◽  
Kathleen D'Hauwers ◽  
Joanna IntHout ◽  
Didi Braat ◽  
Kathrin Fleischer
Keyword(s):  
Oxidative Stress ◽  
Clinical Trial ◽  
Male Fertility ◽  
Time Window ◽  
Nutritional Supplement ◽  
Fertility Treatment ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Infertile Couples

IntroductionInfertility is a worldwide problem and about 10%–15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples, a male factor is involved. Most of the male infertile cases are characterised as ‘idiopathic’, except for a small percentage of cases which are causative by a genetic aetiology. In the past decade, the role of oxidative stress related to sperm quality has been researched thoroughly and estimated to be the problem in 25%–87% of male infertility cases. Impryl is a nutritional supplement which works on the metabolic system and the regulation of oxidative stress by activating the 1-carbon cycle and therefore recycling of homocysteine. We hypothesise that the nutritional supplement Impryl in men of infertile couples might improve the ongoing pregnancy rate.Methods and analysisWe designed a multicentre, randomised, double-blind, placebo-controlled clinical trial. We aimed to include 1200 male adults aged 18–50 years, part of a couple that is diagnosed with infertility. The couple will either start or has already been started with fertility treatment, that is, expectative management (duration of 6 months), intrauterine insemination (IUI) with or without mild ovarian stimulation or ovulation induction, either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment. Male participants will be randomised in either the Impryl or the placebo group, with identical appearance of the tablets to be distributed (doses: one tablet each day), for a total duration of maximal 6 months. Patients can start directly with fertility treatment and/or natural conception. The primary outcome is the number of ongoing pregnancies confirmed by ultrasound at ≥10 to 12 weeks, and conceived in the time window between randomisation up to and including month 6 of intervention use. Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count. Furthermore the number of pregnancies conceived in the optimal intervention time window (after full spermatogenesis of 72 days), overall number of pregnancies, time to pregnancy, embryo fertilisation rate in IVF/ICSI, embryo-utilisation rate in IVF/ICSI, number of miscarriages, live birth rate and adverse events are documented within the study period of 15 months.Ethics and disseminationThe protocol is approved by the local medical ethical review committee at the Radboud University Medical Centre and by the national Central Committee on Research Involving Human Subjects. Findings will be shared with the academic and medical community, funding and patient organisations in order to contribute to optimisation of medical care and quality of life for patients with infertility.Trial registration numbersNCT03337360 and NTR6551.

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