scholarly journals Toxicology and safety of the tincture of Operculina alata in patients with functional constipation

2012 ◽  
Vol 48 (3) ◽  
pp. 469-476
Author(s):  
Luciana Kelly Ximenes dos Santos ◽  
Gilmara Holanda da Cunha ◽  
Francisco Vagnaldo Fechine ◽  
Andréa Vieira Pontes ◽  
Jonaina Costa de Oliveira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Functional Constipation ◽  
Clinical Aspects ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Pharmaceutical Form ◽  
Liver And Kidney ◽  
Pre Treatment ◽  
To Receive

The tincture of Operculina alata, popularly known as "tincture of jalapa", is used in Northeast Brazil to treat constipation and encephalic vascular accident, but it has not yet been adequately tested for safety and efficacy. The aim of this study was to evaluate the toxicology and safety of the tincture of O. alata in patients with functional constipation. This was a double-blind, randomized, placebo-controlled clinical trial. The study consisted of three phases: pre-treatment, treatment and post-treatment, each phase with duration of seven days. Arterial pressure, heart rate, body weight, adverse events, hematological, metabolic, liver and kidney functions were monitored. Forty patients were randomized to receive tincture of O. alata and 43 patients to receive placebo. There were statistical differences in the clinical aspects between groups, but these changes were not considered clinically significant. Adverse events were considered not serious and of mild intensity, especially dizziness, headache, abdominal pain and nausea. This clinical trial confirmed the safety of the tincture of O. alata in the pharmaceutical form and dosage tested, allowing the product to be safely used in a larger population for the assessment of its clinical efficacy.

The Effects of Clomipramine Hydrochloride in Cats With Psychogenic Alopecia: A Prospective Study

2006 ◽  
Vol 42 (5) ◽  
pp. 336-343 ◽  
Author(s):  
Petra A. Mertens ◽  
Sheila Torres ◽  
Carl Jessen
Keyword(s):  
Clinical Trial ◽  
Prospective Study ◽  
Treatment Duration ◽  
Drug Efficacy ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
A Prospective Study ◽  
To Receive ◽  
Insufficient Number

A double-blind, placebo-controlled clinical trial was conducted to determine the efficacy of clomipramine hydrochloride in cats with psychogenic alopecia. Twenty-five cats were randomly assigned to receive clomipramine hydrochloride (0.5 mg/kg orally q 24 hours) or placebo for 56 days. Eleven cats in each group completed the trial. The results of this study showed that clomipramine hydrochloride failed to demonstrate significant changes in the number of grooming bouts, hair regrowth, and the area of alopecia in cats with psychogenic alopecia when compared to a placebo. It was uncertain whether these results reflected a lack of drug efficacy, insufficient treatment duration, or an insufficient number of cases enrolled.

scholarly journals The Effect of Dietary Supplementation of Crocetin for Myopia Control in Children: A Randomized Clinical Trial

2019 ◽  
Vol 8 (8) ◽  
pp. 1179 ◽  
Author(s):  
Kiwako Mori ◽  
Hidemasa Torii ◽  
Satoko Fujimoto ◽  
Xiaoyan Jiang ◽  
Shin-ichi Ikeda ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Large Scale ◽  
Suppressive Effect ◽  
Institutional Review Boards ◽  
Controlled Clinical Trial ◽  
Myopia Progression ◽  
Double Blind ◽  
Institutional Review ◽  
To Receive

The prevalence of myopia has been increasing in recent years. The natural carotenoid crocetin has been reported to suppress experimental myopia in mice. We evaluated the effects of crocetin on myopia suppression in children. A multicenter randomized double-blind placebo-controlled clinical trial was performed with 69 participants aged 6 to 12 years, whose cycloplegic spherical equivalent refractions (SER) were between −1.5 and −4.5 diopter (D). The participants were randomized to receive either a placebo or crocetin and followed up for 24 weeks. Axial length (AL) elongation and changes in SER were evaluated for 24 weeks. Both written informed assent from the participants and written informed consent from legal guardians were obtained in this study because the selection criteria of this trial included children aged between 6 and 12 years old. This trial was approved by the institutional review boards. A mixed-effects model was used for analysis, using both eyes. Two participants dropped out and 67 children completed this trial. The change in SER in the placebo group, −0.41 ± 0.05 D (mean ± standard deviation), was significantly more myopic compared to that in the crocetin group, −0.33 ± 0.05 D (p = 0.049). The AL elongation in the placebo group, 0.21 ± 0.02 mm, was significantly bigger than that in the crocetin group, 0.18 ± 0.02 mm (p = 0.046). In conclusion, dietary crocetin may have a suppressive effect on myopia progression in children, but large-scale studies are required in order to confirm this effect.

scholarly journals The effect of Melissa officinalis syrup on patients with mild to moderate psoriasis: a randomized, double-blind placebo-controlled clinical trial

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Alireza Yargholi ◽  
Leila Shirbeigi ◽  
Roja Rahimi ◽  
Parvin Mansouri ◽  
Mohammad Hossein Ayati
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Herbal Medicines ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Skin Area ◽  
Melissa Officinalis ◽  
Double Blind ◽  
Significant Difference ◽  
Pre Treatment

Abstract Objective Psoriasis is an immune-mediated inflammatory skin disease. It can involve any body skin area, particularly the scalp, lower back, elbows, and knees. There are several topical and systemic therapies for the treatment. Nowadays, herbal medicines are popular treatments for dermatologic conditions. This two-arm parallel, randomized placebo-controlled clinical trial was conducted to examine the hypothesis of the efficacy of Melissa officinalis syrup on patients with mild-to-moderate Plaque psoriasis. Result Among 100 patients, 95 participants completed the trial and five of them withdrew. The mean pruritus intensity and PASI scores decreased significantly in the intervention group compared to the placebo group (P < 0.001). The DLQI score in the intervention group increased post-treatment compared to pre-treatment (P = 0.029); however, there was no significant difference between the intervention and control group at the end of the study (0.065). Trial registration: The trial was registered in the Iranian registry of clinical trials on November 9th, 2019 (https://www.irct.ir/trial/43434; registration number: IRCT20191104045326N1).

scholarly journals Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial

2021 ◽  
Author(s):  
Ling Qu ◽  
Xiaochun Liang ◽  
Guoqing Tian ◽  
Gaili Zhang ◽  
Qunli Wu ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Adverse Events ◽  
Glycosylated Hemoglobin ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Significant Difference ◽  
Acarbose Treatment

<b>OBJECTIVE </b>This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (sangzhi alkaloids, SZ-A) in the treatment of type 2 diabetes (T2D).<a></a> <p><b>RESEARCH DESIGN AND METHODS</b><b> </b><a></a>This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled non-inferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (<i>n</i>=360) or acarbose group (<i>n</i>=240). The primary efficacy endpoint was the change of glycosylated hemoglobin (HbA<sub>1c</sub>) in comparison to baseline. In addition, adverse events (AEs), severe adverse events (SAEs), <a>treatment-related </a><a>adverse events</a> (TAEs), and gastrointestinal disorders (GDs) were monitored.</p> <p><b>RESULTS</b> After treatment for 24 weeks, the change <a>in HbA1c was −0.93% (95% CI −1.03 to −0.83) (−10.2 mmol/mol, [95% CI −11.3 to −9.1]) and −0.87% (95% CI −0.99 to −0.76) (−9.5 mmol/mol, [95% CI −10.8 to −8.3]) in the SZ-A and acarbose groups, and the least squares mean difference was −0.05% (95% CI −0.18 to 0.07) (−0.5 mmol/mol, [95% CI −2.0 to 0.8]) between the two groups with no significant difference based on covariance analysis (P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group (P < 0.01), but no differences were found for AEs or SAEs between two groups were observed (P > 0.05).</a></p> <p><b>CONCLUSION</b> SZ-A exhibited equivalent hypoglycemic effect to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than that following acarbose treatment, suggesting good safety.</p>

Risk of Adverse Events Is Similar in Patients (Pts) Who Did or Did Not Achieve Hemoglobin (Hb) Above 12g/dL in a Phase 3 Clinical Trial of Darbepoetin alfa (DA) Administered Weekly (QW) or Every 3 Weeks (Q3W) in Anemic Cancer Pts Receiving Chemotherapy.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4086-4086
Author(s):  
Heinz Ludwig ◽  
Jean-Luc Canon ◽  
Johan Vansteenkiste ◽  
Lisa Hamilton ◽  
Tamás Suto
Keyword(s):  
Myocardial Infarction ◽  
Clinical Trial ◽  
Adverse Events ◽  
Dose Group ◽  
Exposure Period ◽  
Current Treatment ◽  
Comparable Efficacy ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Impact

Abstract Until now data on the frequency of adverse events (AEs) at different Hb levels have been lacking; these could help to define the impact of using different therapeutic Hb thresholds for erythropoiesis-stimulating agents. To evaluate the impact of when Hb >12g/dL, we evaluated data from a double-blind, randomized, active-controlled clinical trial of DA in anemic cancer pts (Hb <11g/dL) receiving chemotherapy (Canon, JNCI2006;98:373), the most recently conducted trial reflecting approved DA doses (2.25mcg/kg QW and 500mcg Q3W) and current treatment practices in Europe. Methods: This posthoc analysis evaluates transfusion (TFN) and AE data in pts who did or did not achieve Hb >12g/dL during the study. Dose withholding occurred when Hb >13g/dL, and DA was restarted at 60% of previous dose once Hb ≤12g/dL. AEs of interest (hypertension, seizure, ischemic myocardial infarction, and embolism/thrombosis [arterial and venous]) were evaluated. Results: Over 700 pts (50% women) were enrolled. Previously it was reported that the QW and Q3W groups in this study had comparable efficacy (TFN rates from wk 5 to end of treatment, 30% and 23%, respectively), and 23.9% and 21.5%, respectively, reached Hb >13g/dL during the study. In this posthoc analysis, within each dose group and between each group, pts had similar rates of each AE of interest regardless of the maximum Hb achieved on study (Table). 43% in both groups reached Hb >12g/dL; mean (SD) number of QW visits Hb remained above 12g/dL was 5.2 (3.56) and 5.1 (3.89) visits, respectively. Pts with Hb ≤12g/dL had higher rates of death and TFN than those with Hb>12g/dL. Conclusions: Both DA regimens (2.25mcg/kg QW and 500mcg Q3W) were equally effective at preventing the need for TFN. Furthermore, control of Hb in both dose groups was similar as evidenced by the proportion of pts reaching a Hb >12 or 13g/dL. Finally, in this trial, regardless of DA regimen, pts with Hb >12g/dL did not exhibit greater rates of any AE of interest compared to those with Hb ≤12g/dL. Table. Outcomes by Maximum Hb on Study Outcomes Maximum Hb N = Number of pts evaluable; E = Total 16 person week exposure period; n = Number of pts experiencing event; r = Exposure adjusted pt incidence rate based on the number of pts with AEs in a 16-week time period (r=n/E). DA Dose Group ≤ 12g/dL >12g/dL Subjects / Exposure Time [N/E] 2.25μg/kg QW 202 / 177.5 150 / 154.5 500μg Q3W 200 / 177.7 153 / 159.3 Deaths [n(r)] 2.25μg/kg QW 43(0.24) 9(0.06) 500μg Q3W 31(0.17) 7(0.04) Transfusions [n(r)] 2.25μg/kg QW 96(0.54) 26(0.17) 500μg Q3W 85(0.48) 15(0.09) Hypertension [n(r)] 2.25 μg/kg QW 7(3.47) 6(4.00) 500μg Q3W 4(2.00) 4(2.61) Seizure [n(r)] 2.25μg/kg QW 0(0.00) 1(0.67) 500μg Q3W 1(0.50) 0(0.00) Ischemic myocardial infarction [n (r)] 2.25μg/kg QW 2(0.99) 1(0.67) 500μg Q3W 4(2.00) 1(0.65) Embolism/thrombosis (Arterial and Venous) [n (r)] 2.25μg/kg QW 17(8.42) 11(7.33) 500μg Q3W 16(8.00) 14(9.15)

scholarly journals Effect of Lactobacillus rhamnosus GG Administration on Vancomycin-Resistant Enterococcus Colonization in Adults with Comorbidities

2015 ◽  
Vol 59 (8) ◽  
pp. 4593-4599 ◽  
Author(s):  
Shira Doron ◽  
Patricia L. Hibberd ◽  
Barry Goldin ◽  
Cheleste Thorpe ◽  
Laura McDermott ◽  
...  
Keyword(s):  
Adverse Events ◽  
Lactobacillus Rhamnosus ◽  
Concomitant Administration ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Content Type ◽  
Stool Samples ◽  
Vancomycin Resistant ◽  
To Receive ◽  
Stool Cultures

ABSTRACTVancomycin-resistant enterococci (VRE) are endemic in health care settings. These organisms colonize the gastrointestinal tract and can lead to infection which is associated with increased mortality. There is no treatment for VRE colonization. We conducted a randomized, double-blind, placebo-controlled clinical trial to examine the safety and efficacy of administration of the probioticLactobacillus rhamnosusGG (LGG) for the reduction or elimination of intestinal colonization by VRE. Colonized adults were randomized to receive LGG or placebo for 14 days. Quantitative stool cultures for LGG and VRE were collected at baseline and days 7, 14, 21, 28, and 56. Day 14 stool samples from some subjects were analyzed by quantitative PCR (qPCR) for LGG. Patients were closely monitored for adverse events. Eleven subjects, of whom 5 received LGG and 6 received placebo, were analyzed. No differences in VRE colony counts were seen at any time points between groups. No decline in colony counts was seen over time in subjects who received LGG. LGG was detected by PCR in all samples tested from subjects who received LGG but was only isolated in culture from 2 of 5 subjects in the LGG group. No treatment-related adverse events were seen. We demonstrated that LGG could be administered safely to patients with comorbidities and is recoverable in some patients' stool cultures. Concomitant administration of antibiotics may have resulted in an inability to recover viable organisms from stool samples, but LGG DNA could still be detected by qPCR. LGG administration did not affect VRE colonization in this study. (This study was registered at Clinicaltrials.gov under registration no. NCT00756262.)

scholarly journals Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial

2021 ◽  
Author(s):  
Ling Qu ◽  
Xiaochun Liang ◽  
Guoqing Tian ◽  
Gaili Zhang ◽  
Qunli Wu ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Adverse Events ◽  
Glycosylated Hemoglobin ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Significant Difference ◽  
Acarbose Treatment

<b>OBJECTIVE </b>This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (sangzhi alkaloids, SZ-A) in the treatment of type 2 diabetes (T2D).<a></a> <p><b>RESEARCH DESIGN AND METHODS</b><b> </b><a></a>This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled non-inferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (<i>n</i>=360) or acarbose group (<i>n</i>=240). The primary efficacy endpoint was the change of glycosylated hemoglobin (HbA<sub>1c</sub>) in comparison to baseline. In addition, adverse events (AEs), severe adverse events (SAEs), <a>treatment-related </a><a>adverse events</a> (TAEs), and gastrointestinal disorders (GDs) were monitored.</p> <p><b>RESULTS</b> After treatment for 24 weeks, the change <a>in HbA1c was −0.93% (95% CI −1.03 to −0.83) (−10.2 mmol/mol, [95% CI −11.3 to −9.1]) and −0.87% (95% CI −0.99 to −0.76) (−9.5 mmol/mol, [95% CI −10.8 to −8.3]) in the SZ-A and acarbose groups, and the least squares mean difference was −0.05% (95% CI −0.18 to 0.07) (−0.5 mmol/mol, [95% CI −2.0 to 0.8]) between the two groups with no significant difference based on covariance analysis (P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group (P < 0.01), but no differences were found for AEs or SAEs between two groups were observed (P > 0.05).</a></p> <p><b>CONCLUSION</b> SZ-A exhibited equivalent hypoglycemic effect to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than that following acarbose treatment, suggesting good safety.</p>

scholarly journals Effect of Prolonged-Release Pirfenidone on Renal Function in Septic Acute Kidney Injury Patients: A Double-Blind Placebo-Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Jonathan S. Chávez-Iñiguez ◽  
Jorge L. Poo ◽  
Miguel Ibarra-Estrada ◽  
Leonel García-Benavides ◽  
Guillermo Navarro-Blackaller ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Kidney Injury ◽  
Adverse Events ◽  
Kidney Injury ◽  
Primary Objective ◽  
Controlled Clinical Trial ◽  
Prolonged Release ◽  
Double Blind ◽  
Septic Acute Kidney Injury ◽  
The Mean

Background. There is no treatment for septic acute kidney injury (sAKI). The anti-inflammatory activity of prolonged-release pirfenidone (PR-PFD) could be beneficial in this clinical setting. Methods. This study was a double-blind randomized clinical trial in sAKI patients with nephrology consultation at the Civil Hospital of Guadalajara, in addition to the usual treatment of AKI associated with sepsis; patients were randomized to receive either PR-PFD at 1,200 mg/day (group A) or 600 mg/day (group B) or a matched placebo for 7 consecutive days. The primary objective was the decrease in serum creatinine (sCr) and increase in urinary volume (UV); the secondary objectives were changes in serum electrolytes, acid-base status, and mortality. Results. Between August 2016 and August 2017, 88 patients were randomized. The mean age was 54 (17 ± SD) years, and 47% were male. The main site of infection was the lung (39.8%), septic shock was present in 39.1% of the cases, and the mean SOFA score was 8.8 points. 28 patients received PFD 1,200 mg, 30 patients received PFD 600 mg, and 30 patients received placebo. During the study, sCr did not differ among the groups. The reversion rate of sCr, UV, and mortality was not different among the groups ( p = 0.70 , p = 0.47 , and p = 0.38 , respectively). Mild adverse events were not different among the groups. Conclusion. PR-PFD did not improve the clinical course of sAKI and seemed to be safe in terms of adverse events. This trial is registered with NCT02530359.

scholarly journals The Effect of Melissa Officinalis Syrup on Patients With Mild to Moderate Psoriasis: a Randomized, Double-blind Placebo-controlled Clinical Trial

2021 ◽  
Author(s):  
Alireza Yargholi ◽  
Leila Shirbeigi ◽  
Roja Rahimi ◽  
Parvin Mansouri ◽  
Mohammad Hossein Ayati
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Herbal Medicines ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Skin Area ◽  
Melissa Officinalis ◽  
Double Blind ◽  
Significant Difference ◽  
Pre Treatment

Abstract Objective: Psoriasis is an immune-mediated inflammatory skin disease. It can involve any body skin area, particularly the scalp, lower back, elbows, and knees. There are several topical and systemic therapies for the treatment. Nowadays, herbal medicines are popular treatments for dermatologic conditions. This two-arm parallel, randomized placebo-controlled clinical trial was conducted to examine the hypothesis of the efficacy of Melissa officinalis syrup on patients with mild-to-moderate Plaque psoriasis.Result: Among 100 patients, ninety-five participants completed the trial and five of them withdrew. The mean pruritus intensity and PASI scores decreased significantly in the intervention group compared to the placebo group (P<0.001). The DLQI score in the intervention group increased post-treatment compared to pre-treatment (P= 0.029); however, there was no significant difference between the intervention and control group at the end of the study (0.065). Trial registration The trial was registered in the Iranian registry of clinical trials on November 9th, 2019 (https://www.irct.ir/trial/43434 ; registration number: IRCT20191104045326N1).

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