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.

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.

scholarly journals Effect of Jianpi Qinghua Decoction on Gut Microbiota, Intestinal Permeability and Glycolipid Metabolism in Newly Diagnosed T2DM Patients: Study Protocol for a Randomized, Double-blind, Placebo-controlled Clinical Trial

2021 ◽  
Author(s):  
Shenyi Jin ◽  
Sheng Zhang ◽  
Qingguang Chen ◽  
Xu Han ◽  
Yahua Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gut Microbiota ◽  
Intestinal Permeability ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Postprandial Blood Glucose ◽  
Controlled Clinical Trial ◽  
Newly Diagnosed ◽  
Double Blind ◽  
Double Blind Placebo

Abstract BackgroundThe gut microbiome is a key target for traditional Chinese medicines (TCM) to ameliorate type 2 diabetes mellitus (T2DM). Patients with T2DM have quite distinct gut microbiota in comparisons with normal individuals, and it directly influences intestinal permeability. This study aims to investigate the underlying effects of Jianpi Qinghua Decoction on gut microbiota and intestinal permeability in newly diagnosed T2DM patients.Methods / designThis study is a single-center, randomized, double-blind, placebo-controlled clinical trial in 120 subjects with newly diagnosed T2DM. The patients will be randomized in a 1:1 ratio into placebo group (1/10 Jianpi Qinghua Decoction + maltodextrin twice daily, n = 60) and treatment group (Jianpi Qinghua Decoction twice daily, n = 60). The study drugs will be double blinded to both investigators and participants. The visits will be done at baseline (visit 0), 1 month (visit 1), 2 months (visit 2), 3 months (visit 3). Measures include: anthropometric measures, blood pressure, glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2hPG) and serum insulin, total cholesterol (TC), total triglycerides (TG), low-density lipoprotein cholesterol (LDL) and high-density lipoprotein cholesterol (HDL), safety indexs (including blood routine examination, clinical urine tests, liver/renal profile), identifying intestinal permeability used ELISA testing serum LPS, serum intestinal fatty acid binding protein (IFABP), serum Zonulin concentrations and fecal sample collection for gut microbiota profiling through 16S rRNA gene sequencing. Data will be analyzed using SPSS version 26. DiscussionWe describe a clinical research protocol evaluating the impact of Jianpi Qinghua Decoction on gut microbiota and intestinal permeability in newly diagnosed T2DM patients. We assume that adminstration of Jianpi Qinghua Decoction will correct gut microbial dysbiosis and intestinal permeability, leading to improved glycemic control.Trial registrationChinese clinical trial registry, identifier: ChiCTR2000039423（http://www.chictr.org.cn/edit.aspx?pid=62537&htm=4.）.Registered on 27 October 2020.

scholarly journals The Effectiveness of a 5% Retinoic Acid Peel Combined with Microdermabrasion for Facial Photoaging: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Gita Faghihi ◽  
Saghi Fatemi-Tabaei ◽  
Bahareh Abtahi-Naeini ◽  
Amir Hossein Siadat ◽  
Giti Sadeghian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Retinoic Acid ◽  
Adverse Effects ◽  
Treatment Initiation ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Photoaged Skin ◽  
The Mean

Background. Tretinoin has been shown to improve photoaged skin. This study was designed to evaluate the efficacy and tolerability of a 5% retinoic acid peel combined with microdermabrasion for facial photoaging. Materials and Methods. Forty-five patients, aged 35–70, affected by moderate-to-severe photodamage were enrolled in this trial. All patients received 3 sessions of full facial microdermabrasion and 3 sessions of either 5% retinoic acid peel or placebo after the microdermabrasion. Efficacy was measured using the Glogau scale. Patients were assessed at 2 weeks and 1, 2, and 6 months after treatment initiation. Results. The mean ± SD age of participants was 49.55±11.61 years, and the majorities (73.3%) were female. Between 1 month and 2 months, participants reported slight but statistically significant improvements for all parameters (P<0.001). In terms of adverse effects, there were statistically significant differences reported between the 5% retinoic acid peel groups and the control group (P<0.001). The majority of adverse effects reported in the study were described as mild and transient. Conclusion. This study demonstrated that 5% retinoic acid peel cream combined with microdermabrasion was safe and effective in the treatment of photoaging in the Iranian population. This trial is registered with IRCT2015121112782N8.

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 Analgesic and antisympathetic effects of clonidine in burn patients, a randomized, double-blind, placebo-controlled clinical trial

2007 ◽  
Vol 40 (01) ◽  
pp. 29-33
Author(s):  
Ostadalipour Abbas ◽  
Jamshidi Mojgan ◽  
Zamani Alieh ◽  
Jamshidi Maryam ◽  
Ashrafi Tavasoli Ahmad
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Systolic Blood Pressure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Case Group ◽  
Burn Patients ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Oral Clonidine

ABSTRACT Objectives:Unlike most other Analgesic drugs, α2 adrenoceptor agonists are capable of producing analgesia. The aim of this study was to evaluate the Analgesic and antisympathetic effects of clonidine, an α2 adrenoceptor agonist in burn patients.Materials and Methods:This randomized, double-blind, placebo-controlled clinical trial performed on one hundred burn patients in Zarea Hospital, Mazandaran, Iran from august 2004 to July 2005. All patients divided in two groups. Case group (n=50) received oral clonidine, 3.3μg/kg TDS and controls (n=50) received placebo. Heart rate and systolic blood pressure and pain severity Visual analogue score (VAS), were recorded after clonidine administration. Statistical analysis was done by means of Mann Witney U test. Results:50 patients (mean age 28.96±10 years) in case group, and 50 patients (mean age 27.60±11.4 years) in control group were studied. VAS pain scores and heart rate in the clonidine group were significantly lower than the control group (P< 0.0001, P< 0.02).there were no significant difference in systolic blood pressure between the two groups on the first and second day but on third day the systolic blood pressure in clonidine group, was lower than controls significantly (P=0.002). Conclusion: This study demonstrates that the use of oral clonidine affects the hemodynamic response to pain in burn patients. Our study demonstrated that clonidine can produce good analgesia and decreased in sympathetic over activity in burn patients, and also reduce opioid dose requirements.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Parallel Clinical Trial Assessing the Effect of Fructooligosaccharides in Infants with Constipation

Nutrients ◽  
2018 ◽  
Vol 10 (11) ◽  
pp. 1602 ◽  
Author(s):  
Daniela Souza ◽  
Soraia Tahan ◽  
Thabata Weber ◽  
Humberto Araujo-Filho ◽  
Mauro de Morais
Keyword(s):  
Clinical Trial ◽  
Transit Time ◽  
Statistical Significance ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Therapeutic Success ◽  
Double Blind ◽  
Double Blind Placebo ◽  
First Year Of Life

Constipation often begins in the first year of life. The aim of this study was to assess the effect of fructooligosaccharides (FOS) in the treatment of infants with constipation. This randomized, double-blind, placebo-controlled clinical trial included infants with constipation who were randomly assigned to one of two parallel groups: FOS or placebo. Either the FOS supplement or the placebo was added to the infant formula. Thirty-six infants completed the 4-week intervention. Therapeutic success occurred in 83.3% of the FOS group infants and in 55.6% of the control group infants (p = 0.073; one-tailed test). Compared with the control group, the FOS group exhibited a higher frequency of softer stools (p = 0.035) and fewer episodes of straining and/or difficulty passing stools (p = 0.041). At the end of the intervention, the mouth-to-anus transit time was shorter (22.4 and 24.5 h, p = 0.035), and the Bifidobacterium sp. count was higher (p = 0.006) in the FOS group. In conclusion, the use of FOS in infants with constipation was associated with significant improvement in symptoms, but the results showed no statistical significance regarding the success of the therapy compared with the control group. FOS was associated with reduced bowel transit time and higher counts of the genus Bifidobacterium in the stool.

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 Therapeutic effectiveness of Lishi Oral Liquid combined with levocetirizine in treating atopic dermatitis: A randomized double-blind placebo-controlled clinical trial

2019 ◽  
Vol 02 (04) ◽  
pp. 179-183
Author(s):  
Jingxiu Chai ◽  
Jie Ren ◽  
Kexiang Yan ◽  
Feng Xu ◽  
Ying Ma ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Life Quality ◽  
Chinese Herbs ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Oral Liquid ◽  
And Control

Objective: To observe the efficacy and safety of Lishi Oral Liquid (LOL), a Chinese herbs formula, combined with levocetirizine, an antihistamine drug, in patients with damp-heat atopic dermatitis (AD). Methods: A randomized double-blind placebo-controlled clinical trial was conducted. Ninety patients diagnosed with damp-heat atopic dermatitis were randomly assigned to Lishi Oral Liquid group and control group at the ratio of 1:1. Patients were given one Lishi Oral Liquid or placebo three times per day. Both groups were treated with allantoin and vitamin E cream by topical use and levocetirizine by oral administration. Patients were followed up at the second and fourth week. The primary outcome was the scoring of atopic dermatitis (SCORAD). The secondary outcomes were visual analogue scale (VAS) and dermatology life quality index (DLQI). Results: After two weeks of treatment, there were statistical differences in SCORAD between these two groups ([Formula: see text]), whereas VAS and DLQI showed no statistical differences. There were significant differences in SCORAD and VAS between two groups at the end of four weeks of treatment ([Formula: see text]). However, no significant differences were observed in DLQI after four weeks of treatment. No serious adverse event was found during this clinical trial. Conclusion: LOL combined with levocetirizine is effective and safe for damp-heat AD treatment.

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