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Comparison between herb drink of Melissa and black tea in decreasing stress, anxiety and insomnia as well as increasing body`s antioxidant among hospitalized burn patients in Shahid Motahari Hospital

Protocol summary

Summary
We have designed this study to evaluate the effects of Melissa herbal drink on the reduction of stress, anxiety disorders and insomnia and also in the increasing of total body`s antioxidant level in burn patients. This study is a randomized clinical trial that has been done on 36 patients. Patient`s inclusion criterion: age of 18 to 70 years, 35% to 55% burn percentage, need of being hospitalized. Exclusion criteria: pregnancy, lactation, intention to become pregnant during the course of the study, consumption of anti-anxiety drugs or antidepressants or sedative 10 days before starting the study, diabetes, asthma, hypo- and hyper-thyroidism, depression, schizophrenia or psychosis, consumption of serotonin-reuptake inhibitors. The selected patients are divided into two groups of 18 individuals based on random number table. Then 250 cc of Melissa tea are given twice a day (mornings and evenings) to the experimental group and 250 cc of black tea are given twice a day (mornings and evenings) to the control group for 20 days. Depression, anxiety and insomnia are measured via Beck`s , Kettle and Petersburg questionnaires respectively, in both groups once in the beginning of intervention and once more after 20 days. Total antioxidant is measured via Spectrophotometry techniques in both groups once at the beginning of the trial and once more after 20 days. Afterwards the results of both groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205198177N4
Registration date: 2013-08-22, 1392/05/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-22, 1392/05/31
Registrant information
Name
Mohammad Javad Fatemi
Name of organization / entity
Burn Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 4275
Email address
mj-fatemi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-07-06, 1392/04/15
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between herb drink of Melissa and black tea in decreasing stress, anxiety and insomnia as well as increasing body`s antioxidant among hospitalized burn patients in Shahid Motahari Hospital
Public title
Effects of Melissa in decreasing stress, anxiety and insomnia as well as increasing body`s antioxidant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: age of 18 to 70 years, 35% to 55% burn percentage, need of being hospitalized. Exclusion criterion: pregnancy, lactation, intention to become pregnant during the course of the study, consumption of anti-anxiety drugs or antidepressants or sedative 10 days before the start of the study, diabetes, asthma, hypo- and hyperthyroidism, depression, schizophrenia or psychosis, consumption of serotonin-reuptake inhibitors drugs.
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central Department of Tehran University of Medical Sciences, Keshavarz Bvld
City
Tehran
Postal code
1417653761
Approval date
2013-06-02, 1392/03/12
Ethics committee reference number
91-04-129-20101-84041

Health conditions studied

1

Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is

2

Description of health condition studied
Depressive episode
ICD-10 code
F32
ICD-10 code description
In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reduction of energy, and decrease in activity. Capacity for enjoyment, interest, and concentration is reduced, and marked tiredness after even minimum eff

3

Description of health condition studied
Nonorganic insomnia
ICD-10 code
F51.0
ICD-10 code description
A condition of unsatisfactory quantity and/or quality of sleep, which persists for a considerable period of time, including difficulty falling asleep, difficulty staying asleep, or early final wakening

Primary outcomes

1

Description
Total body Antioxidant
Timepoint
In the first day of intervention and 20 days after
Method of measurement
Spectrophotometry techniques

2

Description
Anxiety
Timepoint
In the first day of intervention and 20 days after
Method of measurement
Ketel Questionnaire

3

Description
Depression
Timepoint
In the first day of intervention and 20 days after
Method of measurement
Standard Questionnaire of Beck

4

Description
Insomnia
Timepoint
In the first day of intervention and 20 days after
Method of measurement
Petersburg Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: patients are drinking one glass of Melissa tea in the mornings and one glass of Melissa tea in the evenings for 20 days from the first day of intervention. This tea is teabag with the commercial name of Melis tea and is provided of using one teabag in 250 cc boiling water.
Category
Treatment - Drugs

2

Description
Control: Patients are drinking one glass of black tea in the mornings and one glass of black tea in the evenings for 20 days from the first day of intervention.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Burn Hospital
Full name of responsible person
Mohammad Javad Fatemi
Street address
Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central Department of Tehran University of Medical Sciences, Keshavarz Bvld, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Burn Research Center of Iran University of Medical sciences
Full name of responsible person
Mohammad Javad Fatemi
Position
Associate Professor of Plastic Reconstructive Surgery
Other areas of specialty/work
Street address
Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 4275
Fax
Email
mj-fatemi@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Burn Research Center of Iran University of Medical sciences
Full name of responsible person
Mohammad Javad Fatemi
Position
Associate Professor of Plastic Reconstructive Surgery
Other areas of specialty/work
Street address
Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 4275
Fax
Email
mj-fatemi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Burn Research Center of Iran University of Medical sciences
Full name of responsible person
Mohammad Javad Fatemi
Position
Associate Professor of Plastic Reconstructive Surgery
Other areas of specialty/work
Street address
Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 4275
Fax
Email
mj-fatemi@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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