MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol

Abstract Background Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. Methods This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient’s global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. Discussion The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. Trial registration ClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.

Download Full-text

A timed activity protocol to address sleep-wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial

BMC Geriatrics ◽

10.1186/s12877-021-02397-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Nancy A. Hodgson ◽

Nalaka Gooneratne ◽

Adriana Perez ◽

Sonia Talwar ◽

Liming Huang

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Trial Registration ◽

Phase Iii ◽

Poor Sleep ◽

Sleep Wake Disorders ◽

Clinical Trial Registration ◽

Link Type ◽

Home Based

Abstract Background Sleep-wake disorders occur in most persons living with dementia and include late afternoon or evening agitation, irregular sleep-wake rhythms such as daytime hypersomnia, frequent night awakenings, and poor sleep efficiency. Sleep-wake disorders pose a great burden to family caregivers, and are the principal causes of distress, poor quality of life, and institutionalization. Regulating the sleep-wake cycle through the use of light and activity has been shown to alter core clock processes and suggests that a combination of cognitive, physical, and sensory-based activities, delivered at strategic times, may be an effective mechanism through which to reduce sleep-wake disorders. Methods A definitive Phase III efficacy trial of the Healthy Patterns intervention, a home-based activity intervention designed to improve sleep-wake disorders and quality of life, is being conducted using a randomized two-group parallel design of 200 people living with dementia and their caregivers (dyads). Specific components of this one-month, home-based intervention involve 4 in-home visits and includes: 1) assessing individuals’ functional status and interests; 2) educating caregivers on environmental cues to promote activity and sleep; and 3) training caregivers in using timed morning, afternoon, and evening activities based on circadian needs across the day. The patient focused outcomes of interest are quality of life, measures of sleep assessed by objective and subjective indicators including actigraphy, subjective sleep quality, and the presence of neuropsychiatric symptoms. Caregiver outcomes of interest are quality of life, burden, confidence using activities, and sleep disruption. Salivary measures of cortisol and melatonin are collected to assess potential intervention mechanisms. Discussion The results from the ongoing study will provide fundamental new knowledge regarding the effects of timing activity participation based on diurnal needs and the mechanisms underlying timed interventions which can lead to a structured, replicable treatment protocol for use with this growing population of persons living with dementia. Clinical trial registration Clinicaltrials.gov # NCT03682185 at https://clinicaltrials.gov/; Date of clinical trial registration: 24 September 2018.

Download Full-text

A review of international clinical trial registration

Journal of Chinese Integrative Medicine ◽

10.3736/jcim20070302 ◽

2007 ◽

Vol 5 (3) ◽

pp. 234-242 ◽

Cited By ~ 4

Author(s):

He Yu

Keyword(s):

Clinical Trial ◽

Trial Registration ◽

Clinical Trial Registration ◽

International Clinical Trial

Download Full-text

Clinical Trial Registration: The Time Has Come…

PM&R ◽

10.1016/j.pmrj.2015.11.003 ◽

2015 ◽

Vol 7 (12) ◽

pp. 1203-1204 ◽

Cited By ~ 1

Author(s):

Leighton Chan ◽

Allen W. Heinemann

Keyword(s):

Clinical Trial ◽

Trial Registration ◽

Clinical Trial Registration

Download Full-text

Editorial policies of MEDLINE indexed Indian journals on clinical trial registration

Indian Pediatrics ◽

10.1007/s13312-013-0092-2 ◽

2013 ◽

Vol 50 (3) ◽

pp. 339-340 ◽

Cited By ~ 1

Author(s):

Soumyadeep Bhaumik ◽

Tamoghna Biswas

Keyword(s):

Clinical Trial ◽

Trial Registration ◽

Clinical Trial Registration ◽

Editorial Policies

Download Full-text

Response to Letter to the Editor, “Clinical Trial Registration in Oral Health Journals”

Journal of Dental Research ◽

10.1177/0022034514563955 ◽

2014 ◽

Vol 94 (3_suppl) ◽

pp. 104S-104S

Author(s):

V. Smaïl-Faugeron ◽

H. Fron-Chabouis ◽

P. Durieux

Keyword(s):

Clinical Trial ◽

Oral Health ◽

Trial Registration ◽

Clinical Trial Registration ◽

Letter To The Editor

Download Full-text

Practical and conceptual issues of clinical trial registration for Brazilian researchers

Sao Paulo Medical Journal ◽

10.1590/1516-3180.2014.00441803 ◽

2015 ◽

Vol 134 (1) ◽

pp. 28-33 ◽

Cited By ~ 3

Author(s):

Carolina Gomes Freitas ◽

Thomas Fernando Coelho Pesavento ◽

Maurício Reis Pedrosa ◽

Rachel Riera ◽

Maria Regina Torloni

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

International Committee ◽

New Drugs ◽

Trial Registration ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Registration Process ◽

Trial History ◽

Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

Download Full-text