IRCT | Comparative study of the effectiveness of plant extract combinations from three herbs including Salvia limbata, Equisetum Arvense and Myrtus communis spray on the decrease of the amount of sweating among healthy and mature women.

Protocol summary

Study aim: The purpose of this study, which was carried out on triple-blind clinical trial, is to investigate the antiperspirant effect of plant extract combinations from three herbs of Salvia limbata, Equisetum Arvense and Myrtus communis spray
Design: The clinical trial has a control group whit non-randomized Triple Blind parallel groups.
Settings and conduct: The study group consisted of females between 18 and 40 years old. Participants entered the study consciously after completing a briefing on the research objectives and how to complete the questionnaires and forms, as well as how to properly use the spray, and after filling out the consent form. This study was conducted using Triple Blind method (lack of knowledge of the participants the researcher and statistical consultant on the allocation of study groups until the end of data analysis). For each of the 24 participants in the study, consisted of two treatment group on the axillary region were inserted pads with hydroalcoholic extract of Salvia limbata, Equisetum Arvense and Myrtus communis in a mixture form in 5% ethano and the individuals were given of physical activity in the sports club of the dormitory, and then, after 2 hours the pads were collected from the axillary region and redistributed.
Participants/Inclusion and exclusion criteria: 18-40 year-old women: No history of allergy to natural anti-perspirants and natural ingredients, cutaneous lesion in axillary region, history of metabolic disease and no use of anti-histamine medications at the time of the study.
Intervention groups: The pads soaked in the extracts of the said plants was pasted in one area of the right or left axillary and a control pad (placebo) was used on the other side.
Main outcome variables: Perspiration

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20190904044695N1

Registration date: 2019-10-21, 1398/07/29

Registration timing: retrospective

Last update: 2019-10-21, 1398/07/29

Update count: 0
Registration date: 2019-10-21, 1398/07/29

Registrant information: Name

Mahdi Tavakolizadeh

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 24 3347 3635

Email address

mahdi_tavakoli@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2019-06-22, 1398/04/01
Expected recruitment end date: 2019-07-01, 1398/04/10
Actual recruitment start date: 2019-07-01, 1398/04/10
Actual recruitment end date: 2019-07-11, 1398/04/20
Trial completion date: 2019-07-11, 1398/04/20

Scientific title: Comparative study of the effectiveness of plant extract combinations from three herbs including Salvia limbata, Equisetum Arvense and Myrtus communis spray on the decrease of the amount of sweating among healthy and mature women.

Public title: The study of antiperspirant effect of plant extract combinations from three herbs of Salvia limbata, Equisetum Arvense and Myrtus communis spray.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

No history of hypersensitivity to natural anti-perspiration substances and compounds. No cutaneous lesion in axillary region. No history of metabolic disease Not taking antihistamine drugs while studying

Exclusion criteria:

Use of antiperspirant and anticholinergic drugs People with thyroid or metabolic diseases Sensitivity to natural and skin products
Age: From 18 years old to 40 years old
Gender: Female

Phase

N/A

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board

Sample size

Target sample size: 24

Actual sample size reached: 24

Randomization (investigator's opinion)

Not randomized

Randomization description

Blinding (investigator's opinion)

Triple blinded

Blinding description

The participants, researcher, clinical caregiver, outcome analyst, the analyzer and data monitoring safety committee were unaware of the allocation of study groups. As such, they have not been able to detect, identify or even observe the pads

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Zanjan University of Medical Sciences

Street address

Zanjan Province University of Medical Sciences & Health services, first of Jomhouri Ave, Azadi Blvd, Zanjan

City

Zanjan

Province

Zanjan

Postal code

4515613191
Approval date: 2019-06-11, 1398/03/21
Ethics committee reference number: IR.ZUMS.REC.1398.080

Health conditions studied

1

Description of health condition studied: Sweating
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Weight difference of axillary pads
Timepoint: At the beginning of study and 2 hours after exercise
Method of measurement: Scale

Secondary outcomes

empty

Intervention groups

1

Description: - Intervention group: The study group consisted of females between 18 and 40 years old. Participants entered the study consciously after completing a briefing on the research objectives and how to complete the questionnaires and forms, as well as how to properly use the spray, and after filling out the consent form.This study was conducted using Triple Blind method (lack of knowledge of the participants the researcher and statistical consultant on the allocation of study groups until the end of data analysis). For each of the 24 participants in the study, on the axillary region were inserted pads with hydroalcoholic extract of Salvia limbata, Equisetum Arvense and Myrtus communis in a mixture form in 5% ethano and the individuals were given of physical activity, and then, after 2 hours the pads were collected from the axillary region and redistributed. Weight differences were recorded before and after these two hours. This should have been done for three consecutive days
Category: N/A

2

Description: The study group consisted of females between 18 and 40 years old. Participants entered the study consciously after completing a briefing on the research objectives and how to complete the questionnaires and forms, as well as how to properly use the spray, and after filling out the consent form.This study was conducted using Triple Blind method (lack of knowledge of the participants the researcher and statistical consultant on the allocation of study groups until the end of data analysis). For each of the 24 participants in the study, consisted of two treatment group on the axillary region were inserted pads with hydroalcoholic extract of Salvia limbata, Equisetum Arvense and Myrtus communis in a mixture form in 5% ethano and the individuals were given of physical activity in the sports club of the dormitory, and then, after 2 hours the pads were collected from the axillary region and redistributed. Weight differences were recorded before and after these two hours. This should have been done for three consecutive days, and finally the mean weight difference of the pads in three days was considered as the criterion.
Category: N/A

Recruitment centers

1

Recruitment center: Name of recruitment center

Avini Dormitory

Full name of responsible person

Mahdi Tavakolizadeh

Street address

: Zanjan Province University of Medical Sciences & Health services, first of Jomhouri Ave, Azadi Blvd, Zanjan

City

زنجان

Province

Zanjan

Postal code

4515613191

Phone

+98 24 3347 3635

Email

mahdi_tavakoli@yahoo.com

1

Sponsor: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Mahdi Tavakolizadeh

Street address

: Zanjan Province University of Medical Sciences & Health services, first of Jomhouri Ave, Azadi Blvd, Zanjan

City

زنجان

Province

Zanjan

Postal code

4515613191

Phone

+98 24 3347 3635

Email

mahdi_tavakoli@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Zanjan 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

Zanjan University of Medical Sciences

Full name of responsible person

Mahdi Tavakolizadeh

Position

Assistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Medical Pharmacy

Street address

: Zanjan Province University of Medical Sciences & Health services, first of Jomhouri Ave, Azadi Blvd, Zanjan

City

Zanjan

Province

Zanjan

Postal code

4515613191

Phone

+98 24 3347 3635

Email

mahdi_tavakoli@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Faramarz Dobakhti

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Medical Pharmacy

Street address

: Zanjan Province University of Medical Sciences & Health services, first of Jomhouri Ave, Azadi Blvd, Zanjan

City

Zanjan

Province

Zanjan

Postal code

4515613191

Phone

+98 24 3347 3635

Email

fdobakhti@zums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Mahdi Tavakolizadeh

Position

Assistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Medical Pharmacy

Street address

: Zanjan Province University of Medical Sciences & Health services, first of Jomhouri Ave, Azadi Blvd, Zanjan

City

Zanjan

Province

Zanjan

Postal code

4515613191

Phone

+98 24 3347 3635

Email

mahdi_tavakoli@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

Comparative study of the effectiveness of plant extract combinations from three herbs including Salvia limbata, Equisetum Arvense and Myrtus communis spray on the decrease of the amount of sweating among healthy and mature women.