Evaluation of the Effect of Topical use of Chamomile oil and Dill oil on Abdominal Obesity and Comparison with Placebo Group_ A Randomized Clinical Trial
Determining the effect of topical application of chamomile and dill oil on abdominal obesity
Design
Randomized clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients, rand function of Excel software was used for randomization.
Settings and conduct
This study is conducted in the form of a double-blind randomized clinical trial among those who refer to Iranian medical treatment centers.
Participants/Inclusion and exclusion criteria
Main Inclusion Criteria:
Women between the ages of 25 and 55 years with a waist circumference of >= 80 cm who have the necessary cooperation in taking the medicine and are not pregnant.
Main Exclusion Criteria:
Not using another topical drug that interferes with the effect of the studied drug
Use other weight loss methods
Intervention groups
Intervention group: 6 weeks of the combination of chamomile oil and dill oil once a day in the amount of 2 cc per square meter (in such a way that the entire abdominal area except for the radius of 2 cm around the navel (10 cm square) is completely lubricated and with a thin layer of oil should be covered) without massaging the area. After using the oil, cover the area with a plastic cover and have 30 minutes of aerobic activity and the plastic cover is removed from the abdomen after the aerobic activity.
Control group: topical use of placebo oil (sesame oil) according to the instructions of the intervention group
Main outcome variables
1- Abdominal circumference size
2- Abdominal subcutaneous fat thickness in three areas
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230902059321N1
Registration date:2023-10-18, 1402/07/26
Registration timing:retrospective
Last update:2023-10-18, 1402/07/26
Update count:0
Registration date
2023-10-18, 1402/07/26
Registrant information
Name
Maryam Bashiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8609 5791
Email address
maryambashiri18@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
2022-05-22, 1401/03/01
Actual recruitment end date
2022-11-06, 1401/08/15
Trial completion date
empty
Scientific title
Evaluation of the Effect of Topical use of Chamomile oil and Dill oil on Abdominal Obesity and Comparison with Placebo Group_ A Randomized Clinical Trial
Public title
Effect of Topical use of Chamomile oil and Dill oil on Abdominal Obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between 25 and 55 years
Necessary cooperation in taking medicine
Women suffering from abdominal obesity
Waist circumference greater than 80 cm
The possibility of following up patients
Fill out a consent form by patients
Not pregnant
Exclusion criteria:
Not using another topical drug that interferes with the effect of the studied drug
Use other weight loss methods
Medical condition that prohibits aerobic exercise
Patients who do professional sports activities
Patients on a weight loss diet
History of allergic reaction to topical use of Chamomile oil and Dill oil
The presence of an active skin lesion in the study area
Women who intend to become pregnant during the treatment period
Pregnant women
Patient dissatisfaction
Hypothyroidism and uncontrolled diabetes mellitus
History of using steroid drugs in the last three months
Age
From 25 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into case and control groups by random allocation method. block randomization method and table of random numbers are used to prepare the random list. It is taken in the way that we design a random block with 6 rows and 10 columns and write down the number of 30 letters A and 30 letters B randomly in its houses. With the first patient's visit, the first cell from row 1 of column 1 is selected and assigned to the intervention or control group based on the letter in the patient's cell, and then we draw a line on the corresponding letter with the selected meaning. We do the same for the rest of the patients to finally reach the determined sample size.
We made 60 cards and write letter A on 30 for intervention and on the other 30 letter B for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter (A or B) patients will be assigned to intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention group will receive a can of chamomile and dill oil, and the placebo group will receive a can of sesame oil. The medicine of both groups is ready to be delivered in similar packaging and in a can with dull color. The lid of the placebo oil can is smeared with chamomile and dill essential oil.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.IUMS.REC.1401.133
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E65-E68
ICD-10 code description
Obesity and other hyperalimentation
Primary outcomes
1
Description
Abdominal circumference size
Timepoint
At the beginning of the intervention, then every three weeks until the end of the intervention
Method of measurement
Tape measure
2
Description
Abdominal subcutaneous fat thickness in three areas: the thickness of the horizontal skin fold at 3 cm from the navel and 1 cm below it on the right side, the thickness of the skin fold above the navel at the midpoint of the line between the breast and navel junction, the thickness of the left supra iliac skin fold above the iliac crest. In the left midaxillary line
Timepoint
At the beginning of the intervention, then every three weeks until the end of the intervention
Method of measurement
Skinfold Caliper
Secondary outcomes
1
Description
Body weight
Timepoint
At the beginning of the study and then every three weeks until the end of the study
Method of measurement
Digital weight scale
2
Description
Body Mass Index
Timepoint
At the beginning of the study and then every three weeks until the end of the study
Method of measurement
Dividing people's weight (in kilograms) by the square of height (height times height in meters)
Intervention groups
1
Description
Intervention group: In the intervention group for 6 weeks, a combination of chamomile oil and dill oil once a day in the amount of 2 cc per square meter (in such a way that the entire abdominal area except for the radius of 2 centimeters around the navel (10 square centimeters) is completely lubricated and covered with a thin layer of oil) without massaging the area. After using the oil, cover the area with a plastic cover and have 30 minutes of aerobic activity (fast walking in such a way that the heart rate and breathing rate increase and sweating occurs) and the plastic cover is removed from the abdomen after the aerobic activity.
Category
Treatment - Drugs
2
Description
Control group: The control group received placebo oil for 6 weeks once a day in the amount of 2 cc per square meter (in such a way that the entire abdominal area except for the radius of 2 centimeters around the navel (10 square centimeters) was completely greased and covered with a thin layer of oil. be) used without massaging the area. After using the oil, cover the area with a plastic cover and have 30 minutes of aerobic activity (fast walking in such a way that the heart rate and breathing rate increase and sweating occurs) and the plastic cover is removed from the abdomen after the aerobic activity.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Behesht Iranian traditional medicine healthcare centre
Full name of responsible person
Maryam Bashiri
Street address
No. 847, Behesht St., South Side City Park, Vahdat Eslami St., Hassan Abad Square,
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5558 0388
Email
stm@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine (RICM)
Full name of responsible person
Dr Amir Hossein Jamshidi
Street address
9, Pirnia Allay, Lalezar Street, Jomhuri Street
City
Tehran
Province
Tehran
Postal code
114587111
Phone
+98 21 5563 9724
Email
imhicmr@iums.ac.ir
Web page address
https://oldricm.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine (RICM)
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Bashiri
Position
Traditional Iranian medicine Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Medicine, No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
00 98 55580388
Email
MaryamBashiri18@tahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayye Mahroozade
Position
Traditional Medicine Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
dr.mahroozade@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Bashiri
Position
Iranian traditional medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
MaryamBashiri18@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