Study of therapeutic effects of ointment containing hydro alcoholic extract of root and rhizome of Ruscus hyrcanus woronow in patients with chronic venous insufficiency (Varicos vein); a randomized, double blind, controlled with placebo.
Study of therapeutic effects of ointment containing hydro alcoholic extract of root and rhizome of Ruscus hyrcanus woronow in patients with chronic venous insufficiency (Varicos vein)
Design
Randomized trial by pseudo random numbers table, double blind with parallel control and intervention groups.
Settings and conduct
Topical Varicose vein treatment In patients referring to Specialized clinic of Mostafavian and Dr. Davoudi's office. researcher, participant, clinical caregiver and outcome evaluator are blinded in this trial.
Participants/Inclusion and exclusion criteria
Patients over the age of 18 with asymptomatic lower limb varices vein are enrolled and patients with a history of allergic reaction to the plants of this family; pregnant or breastfeeding; and those with uncontrolled diabetes will not be included.
Intervention groups
Intervention group receive Ruscus extract 2% ointment 2 times daily in amount of 1 cm and For one month. The control group receive placebo ointment in the same way.
Main outcome variables
The amount of pain and feet heaviness; Changes in the amount of swollen ankles; Variation of vascular changes in vascular area according to questionnaire are the main consequences
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100107003014N21
Registration date:2018-12-06, 1397/09/15
Registration timing:registered_while_recruiting
Last update:2018-12-06, 1397/09/15
Update count:0
Registration date
2018-12-06, 1397/09/15
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of therapeutic effects of ointment containing hydro alcoholic extract of root and rhizome of Ruscus hyrcanus woronow in patients with chronic venous insufficiency (Varicos vein); a randomized, double blind, controlled with placebo.
Public title
Effect of hydroalcoholic extract of Ruscus hyrcanus in treatment of chronic venous insufficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
at least 18 years old
varicose grade C1, C2 and C3
Exclusion criteria:
History of allergic reactions to plants in this family
Pregnancy and Lactation
Uncontrolled Diabetes
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Ointments made in "placebo" and "Drug" groups, are numbered in the list by the supervisor. After prescribing by the physician, the code of prescribed ointment will be entered into the questionnaire. Physician, Patient and investigator are not aware of the type of ointment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍٍEthics committee of Mazandaran University of Medical
Street address
Moalem Sq.Vice chancelor of research MAZUMS
City
Sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2018-06-21, 1397/03/31
Ethics committee reference number
IR.MAZUMS.Rec.1397.153
Health conditions studied
1
Description of health condition studied
Varicose vein of lower extremities
ICD-10 code
I83.9
ICD-10 code description
Asymptomatic varicose veins of lower extremities
Primary outcomes
1
Description
The amount of pain and feet heaviness according to the questionnaire.
Timepoint
Completion of the questionnaire and examination at the beginning of the study and 14 and 28 days after the start of the application of Ruscus ointment.
Method of measurement
Aberdeen varicose vein questionnaire (AVVQ), Observation and examination
2
Description
Changes in the amount of swollen ankles according to the questionnaire.
Timepoint
Completion of the questionnaire and examination at the beginning of the study and 14 and 28 days after the start of the application of Ruscus ointment
Method of measurement
Aberdeen varicose vein questionnaire (AVVQ), Observation and examination
3
Description
Variation of vascular changes in vascular area according to questionnaire.
Timepoint
Completion of the questionnaire and examination at the beginning of the study and 14 and 28 days after the start of the application of Ruscus ointment.
Method of measurement
Aberdeen varicose vein questionnaire (AVVQ), Observation and examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ruscus extract 2% ointment/ 2 times daily/ 1 cm of the ointment/ For one month
Category
Treatment - Drugs
2
Description
Control group: ointment formolation without any drugs/ 1 cm of the ointment/ For one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized clinic of Mostafavian
Full name of responsible person
Dr.Shahram Ala
Street address
Payambar azam university complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 18 Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
Sala@mazums.ac.ir
2
Recruitment center
Name of recruitment center
Dr. Davoudi's office
Full name of responsible person
Dr. Shahram ala
Street address
Payambar azam university complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 18 Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
sala@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Shahram ala
Street address
Payambar azam university complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 18 Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ehsan seifi
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Payambar azam university complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 18 Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Email
sala@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Shahram Ala
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Email
sala@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Shahram Ala
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Email
sala@mazums.ac.ir
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