Amelioration of Levetiracetam- induced behavioral side effects by Pyridoxine-Randomized double blinded controlled study

2021 ◽  
Author(s):  
Adel Mahmoud ◽  
Sadia Tabassum ◽  
Shoaa Al Enazi ◽  
Nahed Lubbad ◽  
Ali Al Wadei ◽  
...  
Keyword(s):  
Side Effects ◽  
Controlled Study ◽  
Double Blinded

scholarly journals Improvement of urinary tract symptoms and quality of life in Benign Prostate Hyperplasia patients, associated with consumption of a newly developed whole tomato-based food supplement. A phase II prospective, randomized double-blinded, placebo-controlled study.

2020 ◽  
Author(s):  
Luigi Cormio ◽  
Beppe Calò ◽  
Ugo Falagario ◽  
Manuela Iezzi ◽  
Alessia Lamolinara ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Urinary Tract ◽  
Side Effects ◽  
Phase Ii ◽  
Food Supplement ◽  
Controlled Study ◽  
Urinary Tract Symptoms ◽  
Group B ◽  
Double Blinded

Abstract Background: Benign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients’ quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH.Methods: Forty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for two months a sachet (5 grams) of a newly developed whole tomato food supplement (WTFS) (treatment=Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score questionnaire before and after treatment.Results: All but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (p<0.0002) LUTS since mean IPSS decreased from 9.05+1.15 SE to 7.15+1.04 SD (paired t-test, two-tailed p-value <0.001), and improved life quality (P < 0.0001) A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/ml+1.52 SE vs 6.95+0.76 SE, P = 0.065), with changes being statistical significant only in the subgroup of patients with baseline levels above 10 ng/ml (18.5ng/ml+2.7vs. 10.3+2.1p= 0.009)Conclusions: The new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients

Effectiveness, Safety, and Satisfaction of Silicone Pro Gel in Prophylaxis and Management of Post-Operative Scar: A Randomized, Double-Blinded, Placebo-Controlled Study

2020 ◽  
Vol 103 (5) ◽  
pp. 442-448
Keyword(s):  
Side Effects ◽  
Cesarean Section ◽  
Study Drug ◽  
Controlled Study ◽  
Abdominal Wound ◽  
Study Product ◽  
High Satisfaction ◽  
Double Blinded ◽  
Better Than ◽  
Surface Regularity

Objective: To assess the effectiveness and side effects of Silicone Pro Gel to alleviate scar development among the pregnant women with the first cesarean section, and their satisfaction. Materials and Methods: The present study was a randomized, double-blinded, placebo-controlled study among the women with transverse abdominal wound of the first cesarean section. The formation and improvement of scar was assessed by interventionblinded investigators and patients in terms of redness, height, surface regularity, and attribute of the scar. Ninety women were enrolled into either the study drug or placebo groups by computerized randomization (C0). Women in both groups applied the allocated drugs within 7 to 10 days after cesarean section and had to apply the allocated drugs twice a day. The re-assessment was done at 28±4 days (C1), at 56±4 days (C2) and at 84±4 days (C3). Results: About 76% of women completed the study. The present study product performed better than the placebo in terms of formation of the wound, including height, surface regularity, and attribute of the scar. Neither side effects nor serious complications caused by the study drug were reported. Most women reported high satisfaction and there was no difference of participants’ perception toward the wound between groups. Conclusion: Silicone Pro Gel performed better in terms of alleviation of scar development post cesarean section with high participants’ satisfaction. Keywords: Scar, Photograph assessment, Investigator, Participant

scholarly journals Improvement of urinary tract symptoms and quality of life in benign prostate hyperplasia patients associated with consumption of a newly developed whole tomato-based food supplement: a phase II prospective, randomized double-blinded, placebo-controlled study

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Luigi Cormio ◽  
Beppe Calò ◽  
Ugo Falagario ◽  
Manuela Iezzi ◽  
Alessia Lamolinara ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Urinary Tract ◽  
Side Effects ◽  
Phase Ii ◽  
Food Supplement ◽  
Controlled Study ◽  
Urinary Tract Symptoms ◽  
Group B ◽  
Double Blinded

Abstract Background Benign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients’ quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH. Methods Forty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for 2 months a sachet (5 g) of a newly developed whole tomato food supplement (WTFS) (treatment = Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score (IPSS) questionnaire before and after treatment. Results All but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (P < 0.0002) LUTS since mean IPSS decreased from 9.05 ± 1.15 to 7.15 ± 1.04 (paired t-test, two-tailed P-value < 0.001), and improved life quality (P < 0.0001). A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/mL ± 1.52 vs 6.95 ± 0.76, P = 0.065), with changes being statistically significant only in the subgroup of patients with baseline levels above 10 ng/mL (18.5 ng/mL ± 2.7 vs 10.3 ± 2.1, P = 0.009). Conclusions The new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients.

scholarly journals  Improvement of urinary tract symptoms and quality of life in Benign Prostate Hyperplasia patients associated with consumption of a newly developed whole tomato-based food supplement. A phase II prospective, randomized double-blinded, placebo-controlled study.

2021 ◽  
Author(s):  
Luigi Cormio ◽  
Beppe Calò ◽  
Ugo Falagario ◽  
Manuela Iezzi ◽  
Alessia Lamolinara ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Urinary Tract ◽  
Side Effects ◽  
Phase Ii ◽  
Food Supplement ◽  
Controlled Study ◽  
Urinary Tract Symptoms ◽  
Group B ◽  
Double Blinded

Abstract Background: Benign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients’ quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH.Methods: Forty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for two months a sachet (5 grams) of a newly developed whole tomato food supplement (WTFS) (treatment = Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score (IPSS) questionnaire before and after treatment.Results: All but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (P < 0.0002) LUTS since mean IPSS decreased from 9.05+1.15 to 7.15+1.04 (paired t-test, two-tailed P-value < 0.001), and improved life quality (P < 0.0001). A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/mL+1.52 vs 6.95+0.76, P = 0.065), with changes being statistically significant only in the subgroup of patients with baseline levels above 10 ng/mL (18.5 ng/mL+2.7 vs 10.3+2.1, P = 0.009)Conclusions: The new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients

EFFECTS OF “HOE HOA TAN II” REMEDY IN THE TREATMENT OF INTERNAL HAEMORROHIDS GRADE I, II AND III

2015 ◽  
pp. 80-85
Author(s):  
Van Anh Nguyen ◽  
Van Nhan Le ◽  
Nguyen Nhu Phuong Phan
Keyword(s):  
Side Effects ◽  
Key Words ◽  
Patient Group ◽  
Controlled Study ◽  
Therapeutic Effects ◽  
Radix Angelicae Sinensis ◽  
Randomised Controlled Study ◽  
Citrus Deliciosa ◽  
Randomised Controlled ◽  
Angelicae Sinensis

Objectives: To investigate and evaluate the therapeutic effects of Hoe hoa tan II in the treatment of internal haemorroids grade I, II and III. Ingredients of the remedy include: Hoe Hoa (Styphonolonium japonicum), Chi xac (Fructus citri Aurantii), Hau phac (Magnolia offinalis), Tran bi (Citrus deliciosa Tenore), Thuong thuat (Atractylodes lancea), O mai (Armeniaca vulgaris Lamk), Cam thao (Clycyrrhiza uralensis), Duong quy (Radix Angelicae Sinensis). Subjects and methods: Randomised controlled study (RCT) has been conducted on 60 patients which were divided into two groups, i.e. the first 30 patient group were treated with Hoe hoa tan II remedy 20 g, and the second 30 patient group were treated with Daflon 500 mg in the course of 14 days. Results: Study showed that Hoe hoa tan II has helped improve symptoms of internal haemorroids grade I, II and III such as bleeding, anal exudation, pain, reducing the size of the haemorroid tissues. The remedy has been shown to have the most significant effect on relieving constipation which is typical in haemorroids. The study also revealed no unwanted effects caused by this formula. Conclusion: Hoe hoa tan II can be therapeutically used to treat internal haemorroids grade I, II and III without causing any serious side effects. Key words: Hoe hoa tan II, internal haemorroids grade I, II, III.

Oral Alpha Lipoic Acid Treatment for Symptomatic Diabetic Peripheral Neuropathy: A Randomized Double-Blinded Placebo-Controlled Study

2020 ◽  
Vol 20 (9) ◽  
pp. 1531-1534 ◽  
Author(s):  
Mamdouh R. El-Nahas ◽  
Ghada Elkannishy ◽  
Hala Abdelhafez ◽  
Enas T. Elkhamisy ◽  
Amr A. El-Sehrawy
Keyword(s):  
Peripheral Neuropathy ◽  
Lipoic Acid ◽  
Diabetic Peripheral Neuropathy ◽  
Study Groups ◽  
Controlled Study ◽  
Alpha Lipoic Acid ◽  
Disability Score ◽  
Perception Threshold ◽  
Outcome Parameters ◽  
Double Blinded

Background: Alpha-lipoic acid (ALA) was used in the treatment of diabetic peripheral neuropathy (DPN) using different routes, doses and treatment durations. The aim of this work is to assess the efficacy of oral 600mg ALA twice daily over 6 months in the treatment of patients with DPN. Methods: This is a prospective, single-center, double-blinded, placebo-controlled study conducted at the outpatient clinic of Mansoura Specialized Hospital, Mansoura University. A total of 200 patients with DPN were randomly assigned to add on treatment with either oral 600mg twice daily ALA (n=100) or placebo (n=100) for 6 months. Treatment outcome was assessed using vibration perception threshold (VPT), neurological symptom score (NSS), neurological disability score (NDS), and visual analog scale (VAS) for pain at baseline and at each visit (1, 3 and 6 months) after the start of treatment. Results: Comparison between the study groups regarding the baseline data revealed no statistically significant differences. with respect to the outcome parameters, no significant differences were found between the studied groups at baseline. However, in subsequent visits, ALA-treated patients had significantly better results regarding almost all the outcome parameters (NSS, NDS, VAS, VPT). Mild nausea was reported in 6 patients. None of the studied patients discontinued treatment. Conclusions: Oral 600mg ALA twice-daily treatment for DPN over 6 months is effective, safe and tolerable.

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