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The effect of vinoscin Barij herbal gel containing extract of Aesculus hippocastanum and essential oil of Rosmarinus officinalis on symptoms of varicose veins

Protocol summary

Summary
Design, setting and conduct: This study is a randomized, double-blind, single center,control trial, (Aims) To investigate the effect of Vinoscin Barij gel on the symptoms of varicose veins, (Major Inclusion criteria) on patients less than 75 years old Who referred to Beheshti hospital and those with varicose veins without active lesions, sample size: 50. (Major Exclusion criteria) obesity, pregnant or breast feeding. Intervention: At the beginning of the study they randomly will be divided into two groups : Vinoscin Barij gel or placebo gel will be applied topically on skin. twice daily,Duration: 2 week . Main outcome measures: The participants will be visited (face to face) at baselind and 2 weeks after the start of the study and will be followed in the 3rd, 7th and 10th days after the beginning of the study by telephone. edema (under the knee, above the knee, ankle), skin color changes, superficial thrombosis, venous rupture, pain, itching, feeling heavy in the leg and possible side effects will be recorded and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052712438N23
Registration date: 2017-10-23, 1396/08/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-23, 1396/08/01
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vinoscin Barij herbal gel containing extract of Aesculus hippocastanum and essential oil of Rosmarinus officinalis on symptoms of varicose veins
Public title
The effect of vinoscin Barij herbal gel on varis symptoms in Patients with Varicose Veins
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with varicose veins؛ without active lesions (grades 1 to 5) referred to Beheshti Kashan hospital Exclusion criteria: Age more than 75؛ pregnancy؛ lactation؛ BMI more than 35
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized based on table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2017-05-16, 1396/02/26
Ethics committee reference number
IR.KAUMS.REC.1396.18

Health conditions studied

1

Description of health condition studied
Varicose veins of lower extremities
ICD-10 code
I83.9
ICD-10 code description
Varicose veins of lower extremities

Primary outcomes

1

Description
severity of varicose vein
Timepoint
Baseline and End-of-trial
Method of measurement
CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification

2

Description
Signs: edema (below the knee, above the knee, ankle), skin discoloration, superficial thrombosis, venous rupture
Timepoint
Baseline and End-of-trial
Method of measurement
Observation

3

Description
Symptoms: Pain, swelling, itching, feeling of heaviness in the legs
Timepoint
0, 3, 7, 10, 14 day
Method of measurement
Asking from patient

Secondary outcomes

empty

Intervention groups

1

Description
intervention: topical Barij Vinoscin gel, 2 times a day (Massage) for 2 week
Category
Treatment - Drugs

2

Description
Control: topical placebo gel, 2 times a day (Massage) for 2 week
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti hospital in kashan
Full name of responsible person
Dr Davoodabadi Abdolhossein
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Science
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Kashan university of Medical Science, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kashan University of Medical Science
Proportion provided by this source
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
Kashan University of Medical Science
Full name of responsible person
Dr.M. Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Davoodabadi Abdolhossein
Position
board certifecaed general and thoracic surgery
Other areas of specialty/work
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
davoodabadi_ab@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Reserch Expert
Other areas of specialty/work
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Postal code
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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