Determining the effects of melatonin in improvement of chronic fatigue syndrome and quality of life in patients with pulmonary sarcoidosis
Design
A controlled, parallel groups, randomized, single blinded and phase 3 clinical trial on 100 patients. The online site (www.sealedenvelope.com/simple-randomiser/v1/lists) and the randomization block method are used for randomization.
Settings and conduct
Place of study: Masih Daneshvari Hospital. How to do the study: 100 patients are randomly assigned to the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People over 18 years of age with pulmonary sarcoidosis and concomitant sleep disorder (PSQI ≥ 3) who refer to the sarcoidosis clinic of Masih Deneshvari Hospital and have also signed the study consent form.
Non-inclusion criteria: Patients who are pregnant, lactating, have a history of central nervous system disease, use any sleep-sedating drugs and stimulant drugs, are allergic to melatonin or formulation components, have parasomnias, sleep disorders related to shift work, and fluvoxamine use.
Intervention groups
Patients in the intervention group receive 3 mg of melatonin one hour before going to sleep for three months. In the control group, patients do not use melatonin before going to sleep
Main outcome variables
Average sleeping and waking time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N32
Registration date:2023-05-01, 1402/02/11
Registration timing:prospective
Last update:2023-05-01, 1402/02/11
Update count:0
Registration date
2023-05-01, 1402/02/11
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-20, 1402/02/30
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effects of Melatonin in Improvement of Chronic Fatigue Syndrome and Quality of life in Patients with Pulmonary Sarcoidosis
Public title
Effects of Melatonin in Patients with Pulmonary Sarcoidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old
People with pulmonary sarcoidosis and concomitant sleep disorder (PSQI ≥ 3)
Have signed the consent to participate in the study
Exclusion criteria:
Pregnancy
Breastfeeding
History of central nervous system disease (stroke, epilepsy, tumor, history of neurological manipulation)
Taking any sedative-hypnotic drugs (antihistamines, benzodiazepines)
Taking stimulant drugs
Allergy to melatonin or formulation components
Having parasomnias
Shift work sleep disorder
Taking fluvoxamine
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is used in this study. Twenty-five blocks including 4 patients generated with online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, 2 patients will be assigned to melatonin group and 2 patients will be assigned to control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the main investigator is unaware of the study groups. The randomization form will be provided to the nurse after evaluation of the inclusion and exclusion criteria and administration will be done based on the form. The investigator is blind to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Shahid Beheshti University of Medical Sciences
Street address
3 rd floor, School of Medicine, Evin Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2023-01-10, 1401/10/20
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.206
Health conditions studied
1
Description of health condition studied
Pulmonary Sarcoidosis
ICD-10 code
D86.0
ICD-10 code description
Sarcoidosis of lung
Primary outcomes
1
Description
The amount of sleepiness during the day
Timepoint
At the start and end of the study
Method of measurement
ESS criteria
2
Description
Fatigue state
Timepoint
At the start and end of the study
Method of measurement
FAS and PROMIS criteria
3
Description
Quality of Life
Timepoint
At the start and end of the study
Method of measurement
SF-12 criteria
Secondary outcomes
1
Description
Pulmonary function of patients
Timepoint
At the start and end of the study
Method of measurement
Spirometry
Intervention groups
1
Description
Intervention group: Patients receive 3 mg of melatonin one hour before bedtime for three months.
Category
Treatment - Drugs
2
Description
Control group: Patients do not use melatonin before going to bed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Masih Daneshvari Hospital, Shahid Bahonar Street (Niyavaran), Darabad.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
f_dastan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Yousefian
Position
Hospital pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2227
Email
saahar26@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 2712 2227
Email
f_dastan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Yousefian
Position
Hospital pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2227
Email
saahar26@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after making patients unidentifiable.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
What processes are involved for a request to access data/document
Official letter to the researchers through Email (fzh.dastan@gmail.com)