Protocol summary

Study aim
Determine the efficacy of Thymoxymel with 10% thyme and Thymoxymel with 1.5 g thyme and 3 g thyme on weight loss in overweight people
Design
108 people who have been admitted to the study, who had been previously visited by the doctor, are divided into three groups of 36 members by randomly assigned random numbers.Blocked randomization is intended to ensure that exactly the same number of participants participates in consecutive but equal intervals, into three groups.The size of each block in this study is 36 We assign a number between 1 and 6 to each of the three permutations then we generate 36 random numbers in range 1 through 6 by RANDBETWEEN in Excel
Settings and conduct
108 patients who referred to university clinics who had studied in the study group were divided into 3 groups and To the first group, a normal oxymel with thyme flavor twice everyday 10 cc (as a placebo)To the second group, oxymel with 1.5 grams of thyme , twice everyday 10 cc,To the third group, oxymel with 3 grams of thyme , twice everyday 10 cc,The medication should be given to all three groups for a period of three months at monthly intervals.The shape and taste of all three types of medication are the same.During the study, all people, including doctors, patients, and the person in charge of delivery of the drug, will not be aware of the drug used.
Participants/Inclusion and exclusion criteria
inclusion criterea : Body mass index (BMI) above 25 kg / m Conscious Consent to Participate in the Study Waist to hip ratio index (WHR) in men1 and women 0.9 Not taking any medications in the past month exclusion criterea: pregnancy lactation alcohol use diabetes melitus thymus allergy reaction history acute or chronic liver disease cancer hypo or hyper thyroidism renal failuer Gastroesophageal reflux Unwillingness of the patient to continue participating in the plan for any reason
Intervention groups
the first group, a normal oxymel with thyme flavor twice everyday 10 cc (as a placebo)To the second group, oxymel with 1.5 grams of thyme , twice everyday 10 cc,To the third group, oxymel with 3 grams of thyme , twice everyday 10 cc
Main outcome variables
Weight check in the first and the end of study , Abdominal circumference to hip circumference ratio check in the first and the end of study, BMI check in the first and the end of study , FBS check in the first and the end of study , Liver enzyme check in the first and the end of study, Lipid profile check in the first and the end of study

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171220037976N1
Registration date: 2018-04-21, 1397/02/01
Registration timing: prospective

Last update: 2018-04-21, 1397/02/01
Update count: 0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
Jafar Abolghasemy nezhad shirazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3639 5768
Email address
shirazij@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Thymoxymel with 10% thyme and Thymoxymel with 1.5 g thyme and 3 g thyme on weight loss in overweight people
Public title
The study of the effect of Thyme oxymel on over weight
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index (BMI) above 25 kg / m Conscious Consent to Participate in the Study Waist to hip ratio index (WHR) in men1 and women 0.9 Not taking any medications in the past month
Exclusion criteria:
pregnancy lactation alcohol use diabetes melitus thymus allergy reaction history acute or chronic liver disease cancer hypo or hyper thyroidism renal failuer Gastroesophageal reflux Unwillingness of the patient to continue participating in the plan for any reason
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
108 people who have been admitted to the study, who had been previously visited by the doctor, are divided into three groups of 36 members by randomly assigned random numbers.Blocked randomization is intended to ensure that exactly the same number of participants participates in consecutive but equal intervals, into three groups.The size of each block in this study is 36 We assign a number between 1 and 6 to each of the three permutations then we generate 36 random numbers in range 1 through 6 by RANDBETWEEN in Excel
Blinding (investigator's opinion)
Double blinded
Blinding description
To the first group, a normal oxymel with thyme flavor twice everyday 10 cc (as a placebo)To the second group, oxymel with 1.5 grams of thyme , twice everyday 10 cc,To the third group, oxymel with 3 grams of thyme , twice everyday 10 cc,The medication should be given to all three groups for a period of three months at monthly intervals.The shape and taste of all three types of medication are the same.During the study, all people, including doctors, patients, and the person in charge of delivery of the drug, will not be aware of the drug used.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
medical School, Zand Street,Imam Hossein Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
IR.SUMS.MED.REC.1396.89

Health conditions studied

1

Description of health condition studied
obesity - over weight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Body Mass Index
Timepoint
monthly
Method of measurement
From the division of weight into squared height

Secondary outcomes

1

Description
lipid profile study
Timepoint
At the start and end of study
Method of measurement
blood sampling

2

Description
liver enzyme study
Timepoint
At the start and end of study
Method of measurement
blood sampling

3

Description
abdominal to hip circumference ratio study
Timepoint
monthly
Method of measurement
by meter

4

Description
weight
Timepoint
monthly
Method of measurement
scale

Intervention groups

1

Description
Control group: oxymel with thyme flavore 10 cc twice daily
Category
Placebo

2

Description
Intervention group1: thyme oxymel with 1.5 gram thyme in 10 cc twice daily
Category
Treatment - Drugs

3

Description
Intervention group2: thyme oxymel with 3 gram thyme in 10 cc twice daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Martyr Clinic
Full name of responsible person
Jafar Abolghasemy
Street address
Namazi Square ,Shiraz
City
Shiraz
Province
Fars
Postal code
713485794
Phone
+98 71 3230 5645
Email
shirazij@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
713485794
Phone
+98 71 3230 5645
Email
shirazij@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Jafar Abolghasemy Nezhad Shirazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz Medical School, Imam Hossein Square, Shiraz
City
Shiraz
Province
Fars
Postal code
713485794
Phone
+98 71 3639 5768
Fax
Email
jafar20200@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Majid Nimruzi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Medicine, Zand Avenue, next to the Governor's Office,shiraz
City
Shiraz
Province
Fars
Postal code
713485794
Phone
+98 71 3230 5645
Email
mnimruzi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jafar Abolghasemy nezhad shirazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz Medical School, Imam Hossein Square, Shiraz
City
Shiraz
Province
Fars
Postal code
713485794
Phone
+98 71 3639 5768
Fax
Email
jafar20200@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
BMI- WHR- Average Fat Profiles Participants - Average liver Profile of Participants-Average age of participants - the number of men and women who participated in the study
When the data will become available and for how long
After doing the data analysis and printing the article
To whom data/document is available
All interested researchers
Under which criteria data/document could be used
To complete the same work and through obtaining permission via email or telephone
From where data/document is obtainable
By Dr. Jafar Abolghasemi on 09171130442 or at the Faculty of Medicine of Shiraz, the Department of Traditional Medicine or email address jafar20200@yahoo.com
What processes are involved for a request to access data/document
Submission of the request will then be made within one week of the requested information
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