Treatment of difficult-to-treat-dermatophytosis: results of a randomized, double-blind, placebo-controlled study

Introduction: Difficult-to-treat dermatophytosis is an emerging public health problem in Sri Lanka. Safe, effective and affordable treatment is needed to solve this problem. Therefore this study has assessed the effectiveness and safety of modified Whitfield ointment applied twice daily with oral griseofulvin 500 mg daily given over 8 weeks in patients with difficult-to-treat dermatophytosis. Methodology: A randomized, double-blind, within-patient-placebo-controlled trial was conducted in patients with clinico- mycologically (history, physical examination, direct light microscopy examination of scales in potassium hydroxide mount) confirmed difficult-to-treat dermatophytosis. Lesions were randomized to receive modified Whitfield ointment (5% benzoic acid and 5% salicylic acid) or emulsifying ointment. All patients were given oral griseofulvin 500mg once daily. The outcome measures were clinical assessment of disease severity, the total surface area of the lesions and the patient’s perception of the disease severity at baseline and every two weeks up to a maximum of 8 weeks. Results: Thirty patients completed the study. At two weeks, there was a statistically significant improvement in modified Whitfield ointment arm in the clinical assessment of disease severity and the patients' perception. There was a 7.59% reduction in the surface area of lesions in modified Whitfield ointment arm and a 5.83% increase in the surface area of lesions in the emulsifying ointment arm at two weeks. The difference between the two arms in surface area changes was not statistically significant (p = 0.107, df = 29). Conclusions: A combination of modified Whitfield ointment with griseofulvin is significantly effective, safe and affordable option for treating difficult-to-treat dermatophytosis in the tropics.

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Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/201592 ◽

2015 ◽

Vol 2015 ◽

pp. 1-11 ◽

Cited By ~ 2

Author(s):

Tsuyoshi Miyaoka ◽

Motohide Furuya ◽

Jun Horiguchi ◽

Rei Wake ◽

Sadayuki Hashioka ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Controlled Study ◽

Efficacy And Safety ◽

Treatment Resistant ◽

Double Blind ◽

Double Blind Placebo ◽

Intention To Treat ◽

The Difference ◽

The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

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Beneficial Potential of Banha-Sasim-Tang for Stress-Sensitive Functional Dyspepsia via Modulation of Ghrelin: A Randomized Controlled Trial

Frontiers in Pharmacology ◽

10.3389/fphar.2021.636752 ◽

2021 ◽

Vol 12 ◽

Author(s):

Sul-Ki Kim ◽

Jin-Yong Joung ◽

Yo-Chan Ahn ◽

In-Chul Jung ◽

Chang-Gue Son

Keyword(s):

Psychological Stress ◽

Functional Dyspepsia ◽

Controlled Trial ◽

Controlled Study ◽

Double Blind ◽

Clinical Trial Registration ◽

Wide Range ◽

Total Ghrelin ◽

Vas Scores ◽

The Difference

Background: Functional dyspepsia (FD) is a highly complex pathophysiologic disease, which shows low recovery and high relapse rates. Therefore, a growing number of clinicians and patients are looking for alternative herbal medicine. Banha-Sasim-Tang (BST) is an herbal prescription for treating a wide range of dyspepsia in traditional Korean medicine (TKM).Aim of the study: This study aimed to evaluate the efficacy of BST on FD in patients with psychological stress-related symptoms and to investigate the involvement of ghrelin. This study is registered at https://cris.nih.go.kr/with the identification number KCT 0002811.Materials and methods: A total of 31 participants with FD who met the Rome IV criteria and the psychological stress-related pattern were enrolled in a double-blind, randomized, and controlled study. Participants were randomly assigned to the BST group (10 g twice daily for 4 weeks) or placebo group. The primary endpoint was a change in the Nepean Dyspepsia Index–Korean (NDI-K) score. The secondary endpoints were changes in the Visual Analog Scale (VAS) scores and plasma ghrelin level.Results: All participants completed the study (n = 15 for BST, n = 16 for placebo). BST decreased NDI-K scores compared with placebo, but the difference was not statistically significant (37.40 ± 27.40 vs 22.50 ± 23.85, p = 0.12). VAS scores and plasma total ghrelin levels were significantly improved in patients who were treated with BST (3.19 ± 1.60 vs 1.38 ± 2.85, p = 0.03 for VAS and 105.69 ± 287.89 vs -142.31 ± 314.32, p = 0.03 for total ghrelin). No BST-related adverse effects were observed during the trial.Conclusion: Our results indicate the clinical potential of BST for FD patients and are the first study to show the modulation of plasma ghrelin as one of its corresponding mechanisms.Clinical Trial Registration:https://cris.nih.go.kr/, identifier KCT 0002811.

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A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia

Alzheimer s Research & Therapy ◽

10.1186/s13195-021-00795-7 ◽

2021 ◽

Vol 13 (1) ◽

Author(s):

Shifu Xiao ◽

Piu Chan ◽

Tao Wang ◽

Zhen Hong ◽

Shuzhen Wang ◽

...

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Clinical Trial ◽

Controlled Trial ◽

Drug Effects ◽

Disease Assessment ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo ◽

The Difference

Abstract Background New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China. Methods We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was − 2.15 points (95% confidence interval, − 3.07 to − 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group. Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated. Trial registration ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014

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Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial

Perfusion ◽

10.1177/0267659117715507 ◽

2017 ◽

Vol 32 (7) ◽

pp. 591-597 ◽

Cited By ~ 5

Author(s):

Geoff G. Lockwood ◽

Leilani Cabreros ◽

Dorota Banach ◽

Prakash P. Punjabi

Keyword(s):

Cardiac Surgery ◽

Primary Outcome ◽

Controlled Trial ◽

Morphine Consumption ◽

Controlled Study ◽

Double Blind ◽

Clinical Trial Registration ◽

Subcutaneous Infusion ◽

Randomised Controlled Study ◽

Randomised Controlled

Background: Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Method: Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg-1.hr-1) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. Results: There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l-1. There were no adverse events as a consequence of the study. Conclusion: Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. Clinical trial registration: ISRCTN13424423 ( https://www.isrctn.com )

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A double-blind randomized controlled trial of topical Curcuma xanthorrhiza Roxb. on mild psoriasis: clinical manifestations, histopathological features, and K6 expressions

Medical Journal of Indonesia ◽

10.13181/mji.v27i3.2511 ◽

2018 ◽

Vol 27 (3) ◽

pp. 178-84 ◽

Cited By ~ 1

Author(s):

Githa Rahmayunita ◽

Tjut N.A. Jacoeb ◽

Endi Novianto ◽

Wresti Indriatmi ◽

Rahadi Rihatmadja ◽

...

Keyword(s):

Controlled Trial ◽

Clinical Manifestations ◽

Effective Treatment Option ◽

Psoriasis Area Severity Index ◽

Double Blind ◽

Old Patients ◽

Mean Values ◽

Significant Difference ◽

Curcuma Xanthorrhiza ◽

The Difference

Background: Curcuma xanthorrhiza Roxb. exerts its anti-inflammatory effects by reducing the concentration of IL-6, IL-8, and phosphorylase kinase, which has role in keratinocyte proliferation. Our study aimed to evaluate the efficacy of C. xanthorrhiza in psoriasis.Methods: From 18 to 59 year-old patients with mild psoriasis, 2 similar lesions were selected. The severity assessment was based on the psoriasis area severity index (PASI), Trozak score, and K6 expression. Using a double-blinded randomized method, lesion was treated with 1% C. xanthorrhiza ointment vs placebo for 4 weeks. The results were analyzed by the chi-square test using STATATM V.12 software (Stata Corp.).Results: The study was conducted in 2010 to 2012 with 17 subjects participated. The median of PASI score were reduced significantly in both lesions, either treated with 1% C. xanthorrhiza ointment vs placebo; however when compared between the group, it was not significant (p=0.520). The Trozak score were reduced in lesions treated with 1% C. xanthorrhiza ointment; but it was not significant (p = 0.306). In lesions treated with placebo, the Trozak score was increased significantly. The difference of Trozak score between lesions treated with C. xanthorrhiza and placebo was significant (p=0.024). There was no significant difference of K6 expression in lesions treated with 1% C. xanthorrhiza ointments or placebo as well as on the difference of mean values of K6 expression between the group (p=0.827).Conclusion: Based on the results, 1% C. xanthorrhiza ointment is effective treatment option for mild psoriasis, but longer follow-up period is suggested to confirm this results. C. xanthorrhiza ointment is safe for topical administration as there were no side effects reported in this study.

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902. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of a Single Immunization of Ad26.RSV.preF against RSV Infection in a Viral Challenge Model in Healthy Adults

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz359.061 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S27-S28 ◽

Cited By ~ 3

Author(s):

John DeVincenzo ◽

Efi Gymnopoulou ◽

Els De Paepe ◽

Bryan Murray ◽

Arangassery Rosemary Bastian ◽

...

Keyword(s):

Disease Severity ◽

Healthy Adults ◽

Controlled Study ◽

Clinical Strain ◽

Double Blind ◽

Double Blind Placebo ◽

Qrt Pcr ◽

Rsv Infection ◽

First Time ◽

Over Time

Abstract Background Despite the high disease burden of RSV in older adults and children, there is currently no approved vaccine. Ad26.RSV.preF, an experimental RSV vaccine, has demonstrated immunogenicity and tolerability in first-in-human clinical studies. The aim of this study was to assess the potential of the Ad26.RSV.preF vaccine to protect against RSV infection and disease in an established RSV human challenge model, used for the first time to evaluate a vaccine. Methods We conducted a randomized, double-blind, placebo-controlled, human challenge study (NCT03334695). Healthy adults received 1 × 1011 vp Ad26.RSV.preF vaccine (active) or placebo (pbo) intramuscularly. After 28 days, volunteers were challenged intranasally with a low-passage clinical strain of RSV-A (0.8 mL of Memphis 37b) and then quarantined for 12 days. Nasal washes were collected twice daily throughout quarantine, starting 2 days post-challenge (viral load [VL] by qRT-PCR and quantitative cultures). Disease severity was recorded thrice daily using symptom diary cards. Results Fifty-three volunteers (active, n = 27; pbo, n = 26) were challenged with RSV-A. Quantitative viral assessments were consistently lower in active than pbo. The primary endpoint of the study was met: the area under the curve (AUC) for RSV VL over time (via qRT-PCR) was significantly lower in active pbo (P = 0.012). Median peak VL was lower for active (0 log10 copies/mL) than pbo (5.4 log10 copies/mL). Median AUC for RSV VL over time (quantitative culture) was lower for active than pbo (0 vs. 109, P = 0.002). Disease severity was lower for active than pbo, with a median AUC total symptom score of 35 (active) vs. 167 (pbo) (P = 0.002). Overall, RSV infection (defined by qRT-PCR alone or combined with symptoms) and disease severity over time were lower in active vs. pbo. Conclusion RSV infections, VL, and RSV disease severity were consistently lower in healthy adults receiving Ad26.RSV.preF vs. placebo, demonstrating promising protection from RSV infection and disease. This was the first time that antiviral prevention was observed against RSV after active immunization. Ad26.RSV.preF warrants further evaluation in field trials for efficacy against natural RSV infections in populations considered at risk of severe RSV disease. Disclosures All Authors: No reported Disclosures.

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Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

Journal of Hand Surgery (European Volume) ◽

10.1016/0266-7681(92)90014-s ◽

1992 ◽

Vol 17 (1) ◽

pp. 69-70 ◽

Cited By ~ 79

Author(s):

M. A. LAMBERT ◽

R. J. MORTON ◽

J. P. SLOAN

Keyword(s):

Local Anaesthetic ◽

Steroid Injection ◽

Controlled Trial ◽

Trigger Finger ◽

Controlled Study ◽

Control Group ◽

Methylprednisolone Acetate ◽

Double Blind ◽

Local Steroid Injection ◽

Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

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Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial

Annals of the Rheumatic Diseases ◽

10.1136/ard.2009.117036 ◽

2009 ◽

Vol 69 (6) ◽

pp. 1144-1147 ◽

Cited By ~ 28

Author(s):

A Hartkamp ◽

R Geenen ◽

G L R Godaert ◽

M Bijl ◽

J W J Bijlsma ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Lupus Erythematosus ◽

Controlled Trial ◽

Well Being ◽

Controlled Study ◽

Systemic Lupus ◽

Double Blind ◽

Female Patients ◽

General Fatigue ◽

Mental Well Being

ObjectiveDehydroepiandrosterone (DHEA) has been reported to improve fatigue and reduced well-being. Both are major problems in patients with systemic lupus erythematosus (SLE), even with quiescent disease. Low serum DHEA levels are common in SLE. The present work investigates the effects of DHEA administration on fatigue, well-being and functioning in women with inactive SLE.MethodsIn a double-blind, randomised, placebo-controlled study, 60 female patients with inactive SLE received 200 mg oral DHEA or placebo. Primary outcome measures were general fatigue, depressive mood, mental well-being and physical functioning. Assessments were made before treatment, after 3, 6 and 12 months on medication, and 6 months after cessation of treatment.ResultsPatients from the DHEA and placebo group improved on general fatigue (p<0.001) and mental well-being (p=0.04). There was no differential effect of DHEA. The belief that DHEA had been used was a stronger predictor for improvement of general fatigue than the actual use of DHEA (p=0.04).ConclusionsThe trial does not indicate an effect of daily 200 mg oral DHEA on fatigue and well-being, and therefore DHEA treatment is not recommended in unselected female patients with quiescent SLE.Clinical Trials Registration Number NCT00391924

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Reliable and rapid smooth extubation after Ketofol for induction of general anesthesia in Laparoscopic Drilling of polycystic ovary: A randomized controlled trial

10.21203/rs.3.rs-29085/v1 ◽

2020 ◽

Author(s):

Atef Mohamed Sayed Mahmoud ◽

Joseph Makram Botros ◽

Safaa Gaber Ragab

Keyword(s):

General Anesthesia ◽

Polycystic Ovary ◽

Controlled Trial ◽

Controlled Study ◽

Double Blind ◽

Randomized Controlled ◽

Airway Response ◽

American Society ◽

American Society Of Anesthesiologists ◽

Better Than

Abstract Background the outcome of ketofol on the hemodynamics and the airway response during induction of general anesthesia has been studied before. Its effect on smoothness of extubation has not been studied before. So, we aimed to assess the effect of ketofol on the smoothness of extubation and compare it with propofol only for induction of general anesthesia. Methods This double-blind, randomized, and controlled study was conducted on one hundred and six American Society of Anesthesiologists Physical status ''ASA PS'' class I and II female patients aged 18–40 years old and scheduled for laparoscopic drilling for polycystic ovary disease under general anesthesia. The patients were assigned into one of two groups (53) patients each; group KP = ketofol and group P = propofol. Results There was good sedation score during suction and extubation in the ketofol group. Airway response and smoothness of extubation were better in the ketofol group better than the propofol group. Conclusion Ketofol as an induction anesthetic agent was effective in attenuating the airway response during extubation more than profofol only. Trial registration: This trial was retrospectively registered at the Clinical Trial.gov with the Identification Number: NCT04365686.

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A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

JOURNAL FOR CLINICAL AND DIAGNOSTIC RESEARCH ◽

10.7860/jcdr/2021/46341.14400 ◽

2021 ◽

Author(s):

Victor Ifeanyichukwu Modekwe ◽

Jideofor Okechukwu Ugwu ◽

Okechukwu Hyginus Ekwunife ◽

Andrew Nwankwo Osuigwe ◽

Jideofor Chukwuma Orakwe ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Controlled Study ◽

Categorical Variables ◽

Paediatric Surgery ◽

Peripheral Oxygen Saturation ◽

Double Blind ◽

Oral Ketamine ◽

The Mean ◽

Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

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