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Investigation of efficacy of "Monavvem" capsule comparing to placebo on the quality of sleep in patients with chronic insomnia

Protocol summary

Study aim
In this study, the therapeutic effects of Monavvem capsule versus placebo on chronic insomnia with high prevalence, physical complications and significant sociao-economical burden are studied.Thus, changes in mental quality of sleep, latency in sleep, sleep time, sleep efficiency, sleep disorders, need for sleep medication, patient daily function, ISI, PSQI, HAM-A, HAM- D is measured.
Design
Control group, groups, blind, randomized Clinical trials
Settings and conduct
Chronic insomnia patients are evaluated in sleep clinic based on DSM-5 and ICSD3 criteria and inform consent form. Subjects completed HAM-A, HAM-D, PSQI, and ISI questionnaires. Patients are randomly divided into two groups of placebo and placebo and randomly divided into two groups.In this study, 224 capsules or placebo were given to each group for eight weeks(4 capsules per day divided into 2 capsules each evening and 2 capsules each night before bedtime with a distance from the meal).The completed questionnaires will be completed in the fourth and eighth weeks.Patients are advised to complete the daily sleep information form at home.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Individuals aged 18 to 65 with the diagnosis of insomnia; ISI Score more than 7; no history of severe drug reaction to certain types of herbal medicines found in the drug; without using sleep aid medication in a week ago; Patients with the oral or written informed consent.Exclusion criteria: severe organic or psychiatric diseases as Parkinson's, Alzheimer's; alchohol or substance abuse; any other medication use or their withdrawal which affects sleep; history of blood coagulation disorders; other sleep disorders; pregnancy and lactation
Intervention groups
Drug group and placebo group
Main outcome variables
Severity index Insomnia, Total score of Pittsburgh, Hamilton's Anxiety Rating, Hamilton's Depression Scale Questionnaires

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190217042737N1
Registration date: 2019-02-25, 1397/12/06
Registration timing: registered_while_recruiting

Last update: 2019-02-25, 1397/12/06
Update count: 0
Registration date
2019-02-25, 1397/12/06
Registrant information
Name
Zohreh Poursaleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 7434
Email address
zpoursaleh7@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-16, 1397/04/25
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of efficacy of "Monavvem" capsule comparing to placebo on the quality of sleep in patients with chronic insomnia
Public title
The effect of "Monavvem" capsule on chronic insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria: Inclusion Criteria:Individuals aged 18 to 65 with the diagnosis of insomnia; ISI Score>7; no history of severe drug reaction to certain types of herbal medicines found in the drug; without using allopathic sleep aid medication in a week ago; Patients with the oral or written informed consent
Exclusion criteria:
Exclusion critria: Patients with uncontrolled and severe organic or psychiatric diseases as Parkinson's disease, Alzheimer's; alchohol or substance abuse; any other medication use or their withdrawal which affects sleep; history of blood coagulation disorders as thrombosis or emboli; other sleep disorders; pregnancy and lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization block, individual, statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, major researcher, Data Collector
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tavanir Cross.,Vanak Square,
City
Tehran
Province
Tehran
Postal code
1516745811
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
ECH.REC.1397.878

Health conditions studied

1

Description of health condition studied
Insomnia
ICD-10 code
G47.0
ICD-10 code description
Insomnia

Primary outcomes

1

Description
Severity Insomnia
Timepoint
Baseline, 4th week, 8th week
Method of measurement
severity index Insomnia (ISI)

2

Description
Sleep Quality
Timepoint
Baseline, 4th week, 8th week
Method of measurement
Sleep Quality Assessment (PSQI)

3

Description
Anxiety
Timepoint
Baseline, 4th week, 8th week
Method of measurement
Hamilton's Anxiety Rating Scale (HAM-A)

4

Description
Depression
Timepoint
Baseline, 4th week, 8th week
Method of measurement
Hamilton's Depression Scale (HAM-D)

Secondary outcomes

1

Description
Side effects
Timepoint
The end of study
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Fourth 690 mg capsules of Monavvem capsule, two capsules at evening and two capsules at night (one hours before usual sleep time)
Category
Treatment - Drugs

2

Description
Control group: Fourth 690 mg capsule of Placebo, two capsules at evening and two capsules at night (one hours before usual sleep time)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiatallah Sleep clinic
Full name of responsible person
زهره پورصالح
Street address
Mulla Sadra St,. Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 2816 2314
Email
z_poursaleh7@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Deputy Research and Technology
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1435945811
Phone
+98 21 8877 3521
Email
z_poursaleh7@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
Zohreh Poursaleh
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Tavanir Cross,. South Valiasr Ave,. Vanak squ
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8877 3521
Email
z_poursaleh7@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Movahhed
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
میدان ونک، خیابان ولیعصر جنوبی، تقاطع توانیر
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
movahhedm54@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Poursaleh
Position
Student of PhD
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Tavanir Cross,. South Valiasr St,. Vanak Square
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
z_poursaleh7@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
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