Background Some of the relatively newer, more efficacious, and potent topical wound dressing solutions include tetrachlorodecaoxide and super-oxidised solution. This study compares the efficacy and safety of these two drugs. Methods This is a block-randomised, double blind, parallel-arm, post-marketing study. One hundred fifty patients with ulcers (75 blocks uniform for sex, ulcer aetiology, diabetes mellitus, and wound area score) were randomised into the two treatment arms. Patients were observed for eight weeks with weekly assessments. One hundred and twenty patients completed the study. Wound healing was objectively assessed by measurement of wound area, scoring of wound exudation and tissue type, and using the pressure ulcer scale of healing Tool (validated for multiple wound aetiologies). Subjective improvement in pain was noted using a visual analogue scale. Both groups were compared using Mann-Whitney U test on all indicators. Results Difference in change in wound tissue type in the two groups was significant (${\alpha}$=0.05) by intention-to-treat (ITT) and per-protocol (PP) analysis at the end of week two (ITT and PP, P<0.001) and week four (ITT, P=0.010; PP, P=0.009). P-values for other comparisons were not significant (P>0.05). No study-related adverse events were observed. Conclusions Both drugs are efficacious. Tetrachlorodecaoxide yields healthy granulation tissue earlier. Both drugs appear to be safe for application.
Akhavan-Karbassi, Mohammad Hasan;Yazdi, Mohammad Forat;Ahadian, Hakimeh;Sadr-Abad, Maryam Jalili
Asian Pacific Journal of Cancer Prevention
/
v.17
no.7
/
pp.3611-3614
/
2016
Background: Propolis based preparations have a wide range of applications in various specialties of dentistry. The aim of this clinical trial was to test the efficacy of propolis as a mouthwash in the reduction of chemotherapy induced oral mucositis (OM) in a single center. Materials and Methods: In this randomised, controlled study patients undergoing chemotherapy were included consecutively and randomised to an experimental group receiving propolis mouthwash (n = 20) and a control group receiving diluted water (n=20). Oral mucositis, erythema and eating and drink ability were assessed at baseline and after 3 and 7 days using the World Health Organization (WHO) scale and the oral mucositis assessment scale (OMAS). Results: There were significant differences in OM, wound and erythema in propolis group compared to placebo, but no significant difference in eating and drink ability. However, it was interesting that 65% of the patients in the propolis group were completely healed at day 7 of the trial. No significant adverse events were reported by the patients. Conclusions: This study found that oral care with propolis as mouthwash for patients undergoing chemotherapy is an effective intervention to improve oral health. Our findings shouldlencourage health practitioners to apply propolis mouth rinse for the oral care of patients under chemotherapy.
Purpose: Impaired intestinal mucosal integrity may affect the gastrointestinal function, especially in relation to nutrition, absorption, and barrier function. The purpose of this study was to measure the prevalence of impaired intestinal mucosal integrity in presumed healthy children aged 1-3 years and assess the effects of zinc, glutamine, fiber, and prebiotic supplementation in them. Methods: A cross-sectional study was conducted in 200 children aged 1-3 years in Pasar Minggu, South Jakarta, Indonesia. A randomized double-blind parallel group method clinical trial was then performed to assess the effects of zinc, glutamine, fiber, and prebiotic supplementation. Results: Elevated calprotectin was found in 91/200 subjects (45.5%) at the onset of the study. After 10 months, 144 subjects completed the study: 72 subjects received the trial formula, whereas the other 72 received the standard formula. A transitory decrease in fecal calprotectin (FC) was observed after 6 months in the subgroup with normal FC levels, who were fed the test formula (p=0.012). Conclusion: The prevalence of impaired intestinal mucosal integrity in this group of Indonesian children aged 1-3 years was high. Supplementation with zinc, glutamine, fiber, and prebiotics during 6 months reduced FC only in those who had low levels at baseline but not in those with impaired integrity.
Journal of the Korean Association of Oral and Maxillofacial Surgeons
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v.29
no.3
/
pp.157-162
/
2003
Background : The surgical removal of impacted mandibular third molar can result in considerable pain, swelling, and dysfunction that patient are incapable of work for several days. Factors contributing to post operative swelling, trismus and pain are complex. There is no question but that the procedure of surgically removing an impacted mandibular third molar is inherently a traumatic one and that some sequelae related to the inflammation response are expected. Meticulous surgical technique will minimize the sequelae of inflammation but will not prevent them. In an effort to minimize these sequelae the use of steroid was instituted. Patients and Methods : Present study was to investigate the effect of one preoperative steroid injection in the masseter muscle to the patients(male 9, female 11) who needed prophylactic removal of bilateral, symmetrical, impacted wisdom teeth in the mandible on the complaint like swelling, trismus and pain. through Double-Blind test. Results : 1. After 24 hours investigation, preoperative steroid injection had significantly reduced swelling with 39% and trismus with 57.5%. 2. $7^{th}$ post operative day investigation, reduced swelling and trismus had shown, however, not significant. 3. There wasn't major difference from the group who took preve-ntive steroid in the visual analogue scale, the first analgesic intake time and the pain period. 4. There wasn't any adverse reaction of steroid for 20 patient From the above result, If the patients are not contraindication to steroid and pronounced post operative reaction can be expected the use of steroid to the surgical removal of impacted mandibular third molar is recommended.
Proceedings of the Korean Society of Food Science and Nutrition Conference
/
2001.12a
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pp.52-60
/
2001
Purpose: We performed a randomized, double-blind, placebo-controlled trial in mild to moderate myopia patients to evaluate the benefit of taking a nutrient supplement containing anthocyanoside oligomers for improving nocturnal visiual function and/or clinical symptoms. Methods: The subjects included have refractive error between -lD(Diopters) $\~$-8D in both eyes, symptoms of decreased night vision and asthenopia based on the scoring result of a pre-structured questionnaire, and abnormal results of mesopic contrast sensitivity(MCS) screening test showing abnormal curve of contrast sensitivity in the middle and high frequency level, between 6.0 and 30.0 CPD(Cycles per degree) at mesopic condition(-2$\~$0 log cd/$m^2$). Total 60 people who qualified the criteria above were enrolled and the subjects were instructed to take the investigational product (anthocyanoside or placebo) twice daily for a 4 week period. The enrolled subjects were investigated for nocturnal vision performance by MCS and clinical symptoms at their first visit and re-evaluated at post-intervention (4 weeks later). MCS was measured and improvement of contrast threshold level according to each CPD was calculated by subtracting initial values from final values. Age, refractive error, and MCS were compared between the placebo and anthocyanoside. Results: After 4 weeks of drug administration 22 of the anthocyanoside group showed symptom improvement compared to 1 of the placebo group (p=0.000). Contrast sensitivity levels according to each CPD before and after drug treatment showed significant improvement in the anthocyanoside group but not in the placebo group. Mean MCS change of anthocyanoside group is 2.41$\pm$1.91 which showed significant improvement compared to -0.40$\pm$2.47 of the placebo group(p=0.000). MCS changes of anthocyanoside group showed significant improvement compared to placebo group in all levels of CPD(p<0.05). During our investigation none of the subjects complained of specific side effects related to anthocyanoside use. Conclusion: Our results show that under careful selection of people with significant symptoms and definite MCS abnormalities, anthocyanoside oligomers may improve the subjective symptoms and objective MCS results.
Purpose: To evaluate the clinical and microbiological effects of the local use of egg yolk immunoglobulin against Porphyromonas gingivalis (anti-P.g. IgY) as an adjunct to scaling and root planing (SRP) in the treatment of moderate to severe chronic periodontitis. Methods: This was a randomized, placebo-controlled, double-blind trial involving 60 systematically healthy patients with moderate to severe chronic periodontitis. Subjects (n=20/group) were randomly assigned to receive SRP combined with subgingival irrigation of anti-P.g. IgY and anti-P.g. IgY mouthwash, subgingival irrigation of 0.2% chlorhexidine and 0.2% chlorhexidine mouthwash, or subgingival irrigation of placebo and placebo mouthwash for 4 weeks. Probing pocket depth, clinical attachment level, bleeding on probing, and the plaque index were evaluated at baseline and at 4 weeks. Subgingival plaque, gingival crevicular fluid, and saliva were simultaneously collected for microbiological analysis. Results: Our results showed that anti-P.g. IgY mouthwash was as effective as chlorhexidine at improving clinical parameters over a 4-week period. All the groups showed a significant reduction in levels of P.g. at 4 weeks. No significant difference was observed in the test group when compared to placebo regarding the reduction in the levels of P.g. Anti-P.g. IgY significantly suppressed the numbers of red complex bacteria (RCB) in subgingival plaque and saliva in comparison with placebo. No adverse effects were reported in any of the subjects. Conclusions: Within the limitations of the study, the present investigation showed that passive immunization with anti-P.g. IgY may prove to be effective in the treatment of chronic periodontitis due to its ability to improve clinical parameters and to reduce RCB. No significant differences were found between the anti-P.g. IgY and placebo groups in the reduction of P.g.
The purpose of this study was to determine the effect of IPBC(3-lodo-2-propynylbutyl carbamate) on dandruff caused by the anthropophilic fungus Maiassezia furfur. The effects of IPBC on dandruff were examined by evaluating (a) the MIC value of IPBC using broth dilution method : (b) the remnant antimicrobial activity of IPBC containing shampoo on skin disc ; (c) the antidandruff efficacy of 1.0 % IPBC containing shampoo in double blind clinical trial. To investigate the remnant antimicrobial activity of IPBC against Maiassezia furfur, guinea pig-skin disc was washed with antidandruff shampoo and then the diameter of inhibition zone per disc was measured. For clinical trial, thirty healthy volunteers, aged 25-35, participated in 4 week study. At 0,2,4 weeks, examinations of scaling, itching on scalp were carried out. The MIC(Minimun Inhibition Concentration) values of IPBC range from 0.10 to 1.00$\mu$ g/ml and it seems that IPBC is more effective in the MIC values than zinc pyrithione, selenium disulphide, piroctone olamine and comparable to ketoconazole, climbazole. When the rimnant antimicrobial activity of IPBC shampoo on skin disc was determined, 0.5% IPBC shampoo and 2.0% Ketoconazole shampoo resulted in similar antimicrobial effect. In addition, 1.0%,2.0% IPBC shampoo was more effective than 2.0% ketoconazole shampoo. After two and four-weeks of 1.0% IPBC shampoo treatment, there was significant reduction of scaling, itching in test group compared to control group. On the basis of these results, it can be concluded that 1.0% IPBC is more effective than 2.0% Ketoconazole in reducing dandruff. It seems that strong capacity of drug binding to the stratum corneum plays a role in its antidandruff effect since adsorption of active ingredients on scalp is very important factor in reducing dandruff.
Objectives: The aim of this trial is to investigate the effect of Ginseng and Wild Cultivated Ginseng to Heat pattern subject. Methods: Eighty-nine Subjects were diagnosed as heat pattern by Cold-Heat Patternization and divided into Ginseng group (n=30), Wild Cultivated Ginseng group (n=31) and Placebo group (n=28) in their 1 st visit. In each visit, The researchers measured the subject's facial temperature using the infrared thermometer (Testo 835-T1). After that, The subjects were asked to mark the current score of flushing on the Visual Analogue Scale (VAS) and to complete the Chalder-Fatigue Scale (CFS) in each visit. The subjects took the test drug for one week and returned the remaining drug on the 2nd visit. The trial result was analyzed with one-way ANOVA using SPSS for Windows version 18. Results: 1. Systolic blood pressure was significantly lower in the Ginseng group and Wild Cultivated Ginseng group than in the control group (p=0.021). 2. There was no significant difference in facial temperature between each groups. 3. The current score of flushing showed the greatest decrease in the Ginseng group compared to the other groups but there was no significant difference (p=0.205). 4. The score of Chalder-Fatigue Scale was decreased in all groups but not statistically significant (p=0.180). Conclusions: This study showed that taking Ginseng extract and Wild Cultivated Ginseng extract do not affect to heat-rising reaction to the subjects diagnosed as heat pattern.
Objectives: This study was conducted to evaluate efficacy and safety of Punica granatum L. Actinidia chinensis Planch. mixed extract on body fat. Methods: Thirty women were recruited ($25kg/m^2{\leq}body$ mass index [BMI]${\leq}29.9kg/m^2$) ($19yr{\leq}age{\leq}38yr$) and randomized to receive Punica granatum L. Actinidia chinensis Planch. mixed extract or placebo for 8 weeks. During the test, they visited four times including screening. Body fat mass, body fat rate, anthropometric dimensions at waist and hip, waist-hip ratio, total cholesterol, triglyceride, low density lipoprotein-cholesterol (LDL-C), and high density lipoprotein-cholesterol (HDL-C) were measured at screening and 8 weeks after screening. Adverse reaction were also checked each visit. Results: There were no significant differences in all index. But when divide experimental group by BMI index, age, and compliance, less than BMI $27kg/m^2$ group decreased body weight, body fat mass and more than BMI $27kg/m^2$ group also decreased body weight, body fat mass and waist circumference. Less than age 30 years group showed decline of waist circumference, fat free rate and T-cholesterol and more than age 30 years group showed decline of fat free mass. Group with compliance more than 95% was decreased BMI, fat free mass, and hip circumference. Conclusions: There was no significant efficacy as compared with placebo group, but as divide experimental group according to BMI index, age, compliance, mixed extract might be effective to reduce obesity index.
Background: Korean Red Ginseng (KRG) extract has been shown to have beneficial effects in patients with atherosclerosis, suggesting that KRG extract may be effective in preventing subsequent ischemic stroke in patients with severe atherosclerosis. Methods: This double-blind, placebo-controlled trial randomized patients with severe atherosclerosis in major intracranial arteries or extracranial carotid artery, to ginseng group and placebo group. They were given two 500-mg KRG tablets or identical placebo tablets twice daily for 12 months according to randomization. The primary endpoint was the composite of cerebral ischemic stroke and transient ischemic attack during 12 months after randomization. The secondary endpoints were change in volumetric blood flow of the intracranial vessels and the incidence of newly developed asymptomatic ischemic lesions. Any adverse events were monitored. Results: Fifty-eight patients were randomized from June 2016 to June 2017, 29 to ginseng and 29 to placebo, and 52 (28 and 24, respectively) completed the study. One patient in the placebo group, but none in the ginseng group, experienced ischemic symptoms (p = 0.46). Changes in volumetric blood flow and the presence of ischemic brain lesions did not differ significantly in the two groups, and none of these patients experienced adverse drug reactions. Conclusion: Ginseng was well tolerated by patients with severe atherosclerosis, with these patients showing good compliance with ginseng dosing. Ginseng did not show significant effects compared with placebo, although none of the ginseng-treated patients experienced ischemic events. Long-term studies in larger patient populations are required to test the effect of ginseng.
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