Home » Trials » SLCTR/2019/008


Protocol for a randomized, double blind, placebo controlled, crossover trial of melatonin for treatment of sleep disorders in patients with cirrhosis

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SLCTR Registration Number

SLCTR/2019/008


Date of Registration

08 Mar 2019

The date of last modification

Mar 08, 2019



Application Summary


Scientific Title of Trial

Protocol for a randomized, double blind, placebo controlled, crossover trial of melatonin for treatment of sleep disorders in patients with cirrhosis


Public Title of Trial

Protocol for a randomized, double blind, placebo controlled, crossover trial of melatonin for treatment of sleep disorders in patient with cirrhosis


Disease or Health Condition(s) Studied

Cirrhosis, sleep disorders


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1227-6706


Any other number(s) assigned to the trial and issuing authority

P/152/08/2018 (ERC: Kelaniya)


Trial Details


What is the research question being addressed?

Does melatonin improve the amount and quality of sleep in patients with early cirrhosis and will it reduce the daytime sleepiness consequently affecting overall quality of life?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Investigators, Data analysts, Healthcare providers, Outcome assessors


Control

Placebo


Assignment

Crossover


Purpose

Treatment


Study Phase

Phase 4


Intervention(s) planned

Study setting: Gastroenterology & hepatology clinic of the Department of Medicine, University of Kelaniya Located at Colombo North Teaching Hospital Ragama, Sri Lanka.

The subjects of the study will be assigned to 2 groups (intervention & control) by simple randomization.

The intervention group will be given a 3mg dose of melatonin, as single tablet daily (to be taken 30 minutes before their usual bedtime) for 2 weeks.

The control group will receive a starch containing placebo (appearance similar to the intervention drug) as a single tablet daily (to be taken 30 minutes before their usual bedtime) for 2 weeks.

Crossover will be after a washout period of one week from the end of the 1st stage of the trial. The intervention group will be given the placebo and the control group given the intervention drug.

During the trial, both arms of study will be followed up in their usual gastroenterology clinic. The routine medications and investigations will continue as per standard management protocols in cirrhosis.

Participants, Health care providers, data collectors, data analysts, outcome adjudicators will be blinded to the intervention status.


Inclusion criteria

  1. Male and female patients aged 18 years and above
  2. Patients with a diagnosis of cirrhosis with at least two of the following: compatible clinical features, biochemical evidence or histological evidence
  3. Severity of cirrhosis falling under Child-Turcotte-Pugh categories A and B

Exclusion criteria

  1. Patients with obstructive sleep apnoea diagnosed by the following criteria will be excluded (a) neck circumference >17 inches for men and >16 inches for women and (b) Positive Berlin questionnaire
  2. Having evidence of moderate to severe depression on Beck Depression Inventory (score >20)
  3. Other ongoing conditions that affects the central nervous system and sleep patterns including recent cerebrovascular events (within 3 months), uremia
  4. Patients who have consumed alcohol within the last 6 weeks or continue to use alcohol
  5. Patients with other diseases that interfere with sleep including chronic diarrhoeal conditions, chronic airway disease
  6. Cirrhosis of Child Turcotte Pugh class C
  7. Presence of hepatic encephalopathy (HE) (Grade II to IV according to West Haven criteria)
  8. Patients who complain of having moderate to severe pruritus that interferes with sleep
  9. Patients who are on drugs that are directly known to reduce or increase sleep (e.g. antihistamines)
  10. Patients who are continuing to use tobacco (known to reduce melatonin levels in blood)
  11. As this study has a significant number of interviewer administered tools and in the absence of a native Tamil speaking researcher in the team, exclusively Tamil speaking patients will be excluded
  12. Patients with cognitive or psychiatric impairment who are unable to provide an informed consent


Primary outcome(s)

1.

Improvement in sleep quality index [Pittsburgh sleep quality index (PSQI)] from baseline scores.

[

Time point: at the end of 2 weeks of drug therapy and after 1 week of washout

]

Secondary outcome(s)

1.

Improvement in sleep determined by the Epworth sleepiness scale score at baseline

[

Time point: at the end of 2 weeks of drug therapy and after 1 week of washout

]
2.

Improvement in quality of life as assessed by the Short Form Liver Disease Quality of Life Questionnaire (SF-36) score at baseline

[

Time point: at the end of 2 weeks of drug therapy and after 1 week of washout

]
3.

Improvement in hepatic encephalopathy as determined by the Clinical Hepatic Encephalopathy Staging Scale (CHESS) score from baseline

[

Time point: at the end of 2 weeks of drug therapy and after 1 week of washout

]

Target number/sample size

118 (59 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2019-03-12


Anticipated end date

2019-06-30


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None (Investigator funded)


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-10-16


Approval number

P/152/08/2018


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama, Sri Lanka
Telephone:+94-11-2961267
Email: erckelaniya@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof. P Arjuna de Silva
Professor in Medicine & Consultant Physician
Department of Medicine, Faculty of Medicine,Thalagolla Road, Ragama, Sri Lanka
Tel: +94-112961119
Mob: 94 777 572379

apdsilva @yahoo.com

Contact Person for Public Queries

Prof. Madunil A Niriella
Senior Lecturer & Consultant Gastroenterologist
Department of Medicine, Faculty of Medicine,Thalagolla Road, Ragama, Sri Lanka
Tel: +94-112961119
Mob: 94 714 820948

maduniln@yahoo.co.uk


Primary study sponsor/organization

Prof. P Arjuna de Silva
Professor in Medicine & Consultant Physician
Department of Medicine, Faculty of Medicine,Thalagolla Road, Ragama, Sri Lanka
Mob: 94 777 572379

apdsilva @yahoo.com

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description

Not Available


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results