1. Home
  2. Approved trials
  3. » فارسی

Evaluating the safety (safety/harmlessness) and effectiveness of Sigol brand insect repellent spray in healthy volunteer

Protocol summary

Study aim
Evaluating the safety (safety/harmlessness) and effectiveness of Sigol brand insect repellent spray in healthy volunteer
Design
The study is a phase 2, two groups compared to control. The sample size is 10. The study was not randomized.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy in Tehran university of medical sciences, 10 healthy volunteers will be selected and enrolled in the study after signing consent form.1 ml of Sigol insect repellent is sprayed on a forearm and1 ml of ethanol solution 20% DEET is sprayed on the other forearm, after 30 minutes, the treated area is placed in a test cage, and it is exposed to mosquitoes for 3 minutes to measure the number of mosquito landings or exploration.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages 18 to 60, Signing consent form to participate in the study, Observing the study conditions and tendency to attend regular follow-up courses, Insensitivity of volunteers to the experimental herbal composition, Insensitivity or mild sensitivity to mosquito bites. Exclusion criteria: Documented sensitivity to formulation components, susceptibility to mosquito bites, active smokers
Intervention groups
1 ml of Sigol insect repellent a product of Akhavi Laboratory is sprayed on a forearm and after 30 minutes, the treated area is placed in a test cage, and it is exposed to mosquitoes for 3 minutes to measure the number of mosquito landings or exploration. Control group: 1 ml of ethanol solution 20% DEET is sprayed on the other forearm and after 30 minutes, the treated area is placed in a test cage, and it is exposed to mosquitoes for 3 minutes to measure the number of mosquito landings or exploration.
Main outcome variables
Estimated full protection time (Measurement of repellent application time up to the first mosquito landing or exploration)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150101020514N21
Registration date: 2023-03-14, 1401/12/23
Registration timing: prospective

Last update: 2023-03-14, 1401/12/23
Update count: 0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-19, 1402/01/30
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the safety (safety/harmlessness) and effectiveness of Sigol brand insect repellent spray in healthy volunteer
Public title
Evaluating the safety and effectiveness of Sigol insect repellent spray
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 60 Signing consent form to participate in the study Observing the study conditions and tendency to attend regular follow-up courses Insensitivity of volunteers to the experimental herbal composition Insensitivity or mild sensitivity to mosquito bites
Exclusion criteria:
Documented sensitivity to formulation components susceptibility to mosquito bites active smokers
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: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor, The Institute of Pharmaceutical Sciences, Faculty of Pharmacy, 16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-02-26, 1401/12/07
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.123

Health conditions studied

1

Description of health condition studied
Insect bite (nonvenomous)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Estimated full protection time (Measurement of repellent application time up to the first mosquito landing or exploration )
Timepoint
A three-minute interval
Method of measurement
Using a digital camera

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1 ml of Sigol insect repellent a product of Akhavi Laboratory is sprayed on a forearm and after 30 minutes, the treated area is placed in a test cage, and it is exposed to mosquitoes for 3 minutes to measure the number of mosquito landings or exploration.
Category
Prevention

2

Description
Control group: 1 ml of ethanol solution 20% DEET is sprayed on the other forearm and after 30 minutes, the treated area is placed in a test cage, and it is exposed to mosquitoes for 3 minutes to measure the number of mosquito landings or exploration.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Street address
415, Taleghani Avenue.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Akhavi laboratory
Full name of responsible person
Farid Akhavi
Street address
Unit 8, No.17, Tavanir Street, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1434875419
Phone
+98 21 8879 8126
Email
info@akhavilab.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Akhavi laboratory
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
Manger of clinical study unit
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
aniseh_samadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Khamesipour
Position
Professor of Immunoparasitology
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
No. 415, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
alikhamesipour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Clinical traial
Street address
No 415, Taleqani Street
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Loading...