Effects of Melissa officinalis extract on the level of anxiety in patients with leukemia: a randomized, double-blind, placebo-controlled clinical trial
By the first leukemia recognition in patients between 16 and 60 year olds, The Beck Anxiety Inventory will be completed to assess the level of anxiety. 60 patients will be randomly and double blinded divided in to two groups. group one will take two capsules contained of 300 mg Melissa officinalis extract beside an SSRI each day for 8 weeks. Group two will take placebo and SSRI with the same protocol. at the end of week 2,4 and 8 Beck Anxiety Inventory will be completed again and level of anxiety will be assessed. Clinical findings will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041926804N2
Registration date:2017-06-19, 1396/03/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-19, 1396/03/29
Registrant information
Name
Zahra Ayati
Name of organization / entity
Medical University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3867 6727
Email address
ayatiz941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2020-01-01, 1398/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Melissa officinalis extract on the level of anxiety in patients with leukemia: a randomized, double-blind, placebo-controlled clinical trial
Public title
Effect of Lemon balm on anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
age between 18 to 60 years old; patients with new recognized leukemia; patients with anxiety; patients who take one SSRI beside the intervention; no pregnancy; no lactation; no other anti-anxiety herbal drug administration.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Mashhad University of Medical Sciences
Street address
Ahmad Abad Street, Mashhad
City
Mashhad
Postal code
91375-345
Approval date
2017-01-05, 1395/10/16
Ethics committee reference number
IR.MUMS.SP.1395.88
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Beck anxiety Score
Timepoint
before intervention, 2,4 and 8 weeks after intervention
Method of measurement
Beck anxiety intervention
Secondary outcomes
1
Description
Treatment response
Timepoint
at the end of week 8 after intervention
Method of measurement
≥50% improvement in mean Beck Anxiety Inventory score
2
Description
Treatment response
Timepoint
at the end of week 8 after intervention
Method of measurement
difference of mean Beck anxiety score from baseline (treatment response is defined as ≥50% improvement)