Determining the effect of Violet flower extract on improving the symptoms of patients with dry eye disease
Design
A 3-blind, placebo-controlled, parallel-group, randomized, phase 3 clinical trial in 52 patients. Randomization is done with random number table and Random Allocation Software.
Settings and conduct
Patients with dry eye symptoms are examined and diagnosed by an ophthalmologist at Khatam Al Anbia Hospital or private office in Mashhad. Clinical examinations and imaging are performed in order to determine the degree of dry eye using a keratograph. The OSDI and DEQ-5 questionnaires and brain temperament questionnaire are completed by the resident responsible for the project. The patients will be randomly divided into two groups: drug and placebo. 4 weeks later they are checked again by the specialist. In the intervals of 2 and 4 weeks after the intervention, the mentioned forms are completed again for all patients. All objective tests are repeated 4 weeks after intervention using the keratograph.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with complaints of dry eyes; Score of OSDI questionnaire more than 12 and DEQ-5 more than 6; Consent to treatment with herbal medicines; No active eye infection; No history of refractive surgery; Absence of pterygium disease; Not using medicines with dry eye side effect
Intervention groups
The intervention group received 15 cc eye drops containing water extract of violet flower (2 grams per hundred ml) and artificial tears, and the control group received 15 cc eye drops containing placebo and artificial tears.
Main outcome variables
Foreign body sensation, sensitivity to light, blurred vision, eye irritation
Tear breakup time (TBUT), meniscus tear height, conjunctival redness and meibomian gland grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231013059708N1
Registration date:2023-11-25, 1402/09/04
Registration timing:prospective
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Haleh Ghooshkhanei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3878 3310
Email address
halonik_md@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-01, 1402/10/11
Expected recruitment end date
2024-12-30, 1403/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Viola Odorata eye drop on dry eye disease: a randomized clinical trial
Public title
The effect of Viola drop on dry eye
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with complaints related to dry eye syndrome
OSDI questionnaire score is more than 12 and DEQ5 is more than 6
Consent to treatment with herbal and traditional medicines
No active eye infection
No history of refractive surgery
Absence of pterygium disease
Not using drugs with dry eye complications
Exclusion criteria:
The patient's unwillingness to receive treatment
Allergy to herbal medicines
Pregnancy
Breastfeeding
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this design will be block method. Blocks of 4 will be used and the sequence produced by the website https://www.sealedenvelope.com will be provided by the project methodologist and will be placed in closed, sealed, opaque and numbered envelopes and the researcher assistant opens one of the envelopes and the patient will be allocated to the group mentioned in the envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug and placebo will be packed in the same cans, and only the code and method of administration will be written on them. The patient and specialist and the statistical analyst are unaware of the assigned codes, and at the end of the study, the code is decoded by an informed person.
The participant, the researcher, the statistical analyst and Data Safety and Monitoring Committee are unaware of the arrangement of groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethics committee of Mashhad University of Medical sciences, central office of Mashhad University of Medical Sciences, Daneshgah Ave., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-10-07, 1402/07/15
Ethics committee reference number
IR.MUMS.REC.1402.194
Health conditions studied
1
Description of health condition studied
Dry Eye Syndrome
ICD-10 code
H 04.1
ICD-10 code description
Tear film insufficiency, Meibomian gland dysfunction
Primary outcomes
1
Description
Dry Eye symptoms
Timepoint
Before the intervention, 2 weeks and 4 weeks after the intervention
Method of measurement
Completion of the OSDI and DEQ5 questionnaires
2
Description
Tear break time (TBUT)
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
The time of appearance of the first changes after the first blink in seconds with the keratograph
3
Description
Tear meniscus height
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
The height of the lacrimal crescent using the Keratograph values
4
Description
Redness of the conjunctiva
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Using the Keratograph values
5
Description
Meibomian gland grade
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Morphological changes of meibomian glands using the Keratograph values
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Eye drops containing 15 cc of aqueous violet extract (two grams per hundred milliliters) for four weeks, one drop four times a day
Category
Treatment - Drugs
2
Description
Control group: Eye drops containing 15 cc of placebo for six weeks, one drop four times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al Anbia Eye Hopital
Full name of responsible person
Haleh Ghoushkhanei
Street address
Khatam al Anbia hospital, Shahid Gharani Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
halonik_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi Pharm D.
Street address
Deputy of Research and Technology, Gharshi Building, Daneshgah St., Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3881 4043
Email
TafaghodiM@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Haleh Ghooshkhanei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8931
Email
halonik_md@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roshanak Salari, Pharm D.
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mashhad Faculty of Persian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8930
Email
SalariR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Haleh Ghooshkhanei MD.
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Persian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8931
Email
halonik_md@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