Evaluation of the efficacy of the lavender on improving the symptoms of depression of patients with multiple sclrosis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 60 patients. NCSS (Number Cruncher statistical system) software and block random method are used to randomize the study
Settings and conduct
Sixty patients who have been diagnosed with multiple sclerosis and referred to the Imam Rezai Clinic in Shiraz in 2023 will be enrolled in the study. These patients will be randomly allocated to either the placebo group or the lavender (linazepam) group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women aged between 18-50 years with relapsing-remitting multiple sclerosis who score above 11 on the Persian version of the Beck Depression Inventory-II (BDI-II-Persian).
Exclusion criteria:
Pregnancy and lactation
Allergy to N. menthoides and Asteraceae family
Patients with unstable cardiac, renal, and hepatic diseases, seizure and hypothyroidism, and substance or alcohol abuse
Patients who will be lost to follow-up
Patients with severe depression.
Intervention groups
Intrvention group: patients receive 50 to 100mg of sertraline daily with a linazpam(lavender) capsule. Placebo group: patients receive 50 to 100mg of sertraline daily with one placebo capsule.
Main outcome variables
Change in score of Beck Depression Inventory-II (BID-II-Persian)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190726044339N4
Registration date:2023-03-03, 1401/12/12
Registration timing:registered_while_recruiting
Last update:2023-03-03, 1401/12/12
Update count:0
Registration date
2023-03-03, 1401/12/12
Registrant information
Name
Seyed Hamdollah Mosavat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 4105
Email address
hamdi_88114@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of lavender capsules (linazepam) with placebo in improving depression symptoms in patients with multiple sclerosis
Public title
Investigating the effect of lavender on depression in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women with Relapsing-remitting multiple sclerosis patients with aged between ۱۸-۵۰ years
Score above ۱۱ according to Persian- version of the Beck Depression Inventory-II (BDI-II-Persian)
Exclusion criteria:
Pregnancy and breastfeeding
Allergy to lavender
Unstable heart, kidney and liver patients
Seizures
Hypothyroidism
Consumption of alcohol or drugs
Patients who do not follow the study completely
Patients with severe depression
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher enrolls participants based on the convenience sampling method. NCSS software (Number Cruncher Statistical System) and block randomization are used for randomizing the study. In the block randomization method, participants are categorized into 6 blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB), with each block containing 4 participants. In this study, "A" is assigned to the drug group and "B" to the placebo group. For example, in the "ABAB" block, the first person enters the drug group, the second person enters the placebo group, the third person enters the drug group, and the fourth person enters the placebo group. Thus, all eligible participants are randomly assigned to one of the study arms according to the randomization list.
Blinding (investigator's opinion)
Double blinded
Blinding description
Physicians, patients, and drug deliverer will blind to the allocation of intervention. It should be noted that the drugs' containers is the same. Additionally, placebo capsule is similar to lavender capsule regarding the color and shape
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Namazi Square, Imam Reza Clinicا
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2022-08-27, 1401/06/05
Ethics committee reference number
IR.SUMS.MED.REC.1401.253
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in Beck questionnaire score
Timepoint
Measurement of depression severity at the beginning of the study (before the start of the intervention) and 4, 8 weeks after the start of taking the drug or placebo.
Method of measurement
Depression Beck questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Participants in this group will be prescribed one capsule of linazepam, which contains lavender essence, one hour before bedtime for eight weeks at night. This linazepam capsule is a pharmaceutical product available in the market and was purchased from Arum Teb Daro Pharmaceutical Company. Additionally, patients in this group will receive routine treatment for depression, which includes one tablet of sertraline (Abidi-Tehran Pharmaceutical Company, Tehran, Iran) 100 mg per day.
Category
Treatment - Drugs
2
Description
Control group: Participants in this group will be prescribed one placebo capsule one hour before bedtime for eight weeks at night.The placebo capsule is made by the co-pharmacist of the project at the Faculty of Pharmacy of Shiraz University of Medical Sciences.Also, patients in this group receive routine treatment for depression (one sertraline tablet 100 mg per day).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Sara Dehbzorgi
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 917 716 9547
Email
dehbozorgis@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Dehbozorgi
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 917 716 9547
Email
dehbozorgis@sums.ac.ir
Grant name
Mohammad Hashem Hashempur
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Dehbozorgi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 71 3228 7237
Email
dehbozorgis@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Dehbozorgi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 71 3228 7237
Email
dehbozorgis@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mahdi Malekhoseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, Hafez St.
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 71 3228 7237
Email
hamdi_88114@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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