Investigating the clinical effect of administering oral drops containing cinnamon, ginger and lime juice in reducing weight and appetite in obese patients
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 70 patients. The Rand function of Excel software will be used for randomization.
Settings and conduct
The clinical trial in phase 2 will be conducted on 70 obese patients in Shariati Hospital. After signing the consent form, the appetite questionnaire was completed by the patients at the beginning and end of the treatment, and at the end of the treatment, the improvement of the patients' symptoms was scored based on the Likert scale from 0 to 10. Also, the weight of the patients is recorded and compared at the beginning and end of the study. The study is double-blind, and the participants and the researcher are blinded.
Participants/Inclusion and exclusion criteria
Age over 18 years, BMI less than 39.9 and more than 25
Intervention groups
The intervention group will consume 5 drops of cinnamon juice and 5 drops of ginger orally in half a glass of lemon juice. The control group, will consume placebo as 5 drops from two bottles of distilled water containing one drop of cinnamon and ginger essential oil poured into the lid of the bottle
Main outcome variables
the level of appetite; Weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160306026938N18
Registration date:2023-11-19, 1402/08/28
Registration timing:prospective
Last update:2023-11-19, 1402/08/28
Update count:0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
Mahdi Vazirian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1223
Email address
vazirian_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the clinical effect of administering oral drops containing cinnamon, ginger and lime juice in obese patients (phase 2A)
Public title
Investigating the effect of cinnamon, ginger and natural lemon juice in obesity.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of the patient
BMI lower than 39.9 and higher than 25
Age between 18 and 65 years
Exclusion criteria:
Suffering from incurable diseases
Suffering from liver and kidney diseases
Simultaneous use of slimming drugs
Taking anticoagulants such as aspirin, warfarin and clopedogrel
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 70 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 35 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 70.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants and researcher are not informed about receiving either treatment or placebo capsules. Thus, the study is a double-blinded one. The subjects in this study were not either relatives or friends, thus they could not compare the impacts of receiving placebo/treatment. In addition, the appearance of the syrups and their containing package was exactly similar in both Intervention or control group and is not differentiated. Bottles are first coded non-sequentially by someone other than the researcher. All the study subjects received a good deal of information regarding the research plan and have been presented to them. After being randomized through the use of statistical software package, treatment or placebo has been provided for them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods street corner, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2023-05-17, 1402/02/27
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.027
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Weight
Timepoint
The effect of the drug on the patient's weight is measured once every two weeks
Method of measurement
Weighing with scales
Secondary outcomes
1
Description
Appetite
Timepoint
once every two weeks
Method of measurement
Asking the individual - Likert scale
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Control group:
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
دکتر غلامرضا محمدی فارسانی
Street address
. Shariati Research and Medical Center, Jalal Al Ahmad Street, Kargar Shamali st.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-chancellor of research and technology, Tehran university of medical sciences
Street address
Central organization of Tehran university of medical sciences, corner of Ghods Ave., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6412 1223
Fax
Email
Vazirian_m@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6412 1223
Fax
Email
Vazirian_m@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6412 1223
Fax
Email
Vazirian_m@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Title and more details about the data/document
Data would be accessible in related dissertation.
When the data will become available and for how long
The onset of access starts from 2024
To whom data/document is available
All academic staff.
Under which criteria data/document could be used
The documents could be accessible in case of furthur experiments.
From where data/document is obtainable
Tehran University of Medical Sciences, Faculty of Pharmacy, Dr. Mahdi Vazirian
What processes are involved for a request to access data/document