Aim: study of efficacy of Melissa officinalis L. leaf extract on benign palpitation in patients reffered to Mostafa Khomeini's hospital in 2012-13, randomized double blinded placebo control trial, single center, study population: outpatients with palpitation complaint. Inclusion criteria: age 18-60; palpitation as one of the main complaints. Exclution criteria:serious cardiologic and psychological diseases; pregnancy and lactation; declination of participation; irregular use of prescribed drugs; unpredicted side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012712303N1
Registration date:2013-02-24, 1391/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-24, 1391/12/06
Registrant information
Name
Fatemeh Alijaniha
Name of organization / entity
School of traditional medicine, Shahid Beheshti Univerity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 9176
Email address
f.alijaniha@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
finantial source of school of traditional medicine,Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-11-15, 1391/08/25
Expected recruitment end date
2013-05-19, 1392/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of traditionally used remedy from Melissa officinalis L.on benign palpitation in patients reffered to Mostafa khomeini's hospital
Public title
Effect of Melissa officinalis L. on palpitations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: palpitations (abnormal awareness of heartbeat) as one of the main presenting complaint; history of palpitation for at least three months; age between 18 and 60 years; informed consent. Exclusion criteria: mental retardation; psychosis and other serious psychological diseases confirmed by a psychologist; organic heart diseases confirmed by a cardiologist; serious chronic diseases; pregnancy; lactation; consumption of beta-blockers; consumption of antidepressants and anxiolytics and sedatives 10 days before the start of the study; declination of participation; irregular use of prescribed drugs; unpredicted side effects.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Behesht University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Postal code
Approval date
2012-01-07, 1390/10/17
Ethics committee reference number
111
Health conditions studied
1
Description of health condition studied
palpitations
ICD-10 code
R00.2
ICD-10 code description
Awareness of heart beat
Primary outcomes
1
Description
Frequency of palpitations' episodes
Timepoint
Before and after intervention
Method of measurement
asking patients to write it in the form
2
Description
Mean intensity of palpitations' episodes
Timepoint
Before and after intervention
Method of measurement
asking patients to estimate it by VAS and write down in the form
Secondary outcomes
1
Description
Probable mental disorders
Timepoint
Before and after intervention
Method of measurement
validated General Health Questionnaire-28
2
Description
Drug side effects
Timepoint
Before and after intervention
Method of measurement
asking the patients to write their symptoms in the form
Intervention groups
1
Description
Placebo group: Hard gelatin capsule containing 500mg of Melissa leaf dry extract,twise a day,for 14 days
Category
Treatment - Drugs
2
Description
drug groupe: Hard gelatin capsules containing 500 mg of bread powder; twise a day for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Clinic
Full name of responsible person
Fatemeh Alijaniha
Street address
Italia Ave, Felestine Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Traditional Pharmacy,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Mosaddegh
Street address
No.10, Shams Alley, Valiassr Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Pharmacy,Shahid Beheshti 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
School of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Alijaniha
Position
Pharm.D,Ph.D student (Traditional Pharmacy)
Other areas of specialty/work
Street address
No.10, Shams Alley, Valieasr Ave.
City
Tehran
Postal code
Phone
+98 21 8877 3522
Fax
Email
f.alijaniha@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Ph. D, Pharmacology
Other areas of specialty/work
Street address
No.17, 3th Dashtestan Alley, Shariati Ave.
City
Tehran
Postal code
Phone
+98 21 2288 2596
Fax
Email
naseri@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Alijaniha
Position
Ph.D Student
Other areas of specialty/work
Street address
No.10, Shams Alley, Valieasr Ave.
City
Tehran
Postal code
Phone
+98 21 8877 3522
Fax
Email
falijaniha@yahoo.comf.alijaniha@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)