The aim of this study is to determine the effects of curcumin on nicotine dependence, depression, anxiety and metabolic biomarkers in cigarette smokers.
Design
Clinical trial with control group, parallel groups, double-blind (both patients and researchers), randomized, 70 patients, phase 2
Settings and conduct
Population and sample size: 70 eligible cigarette smokers and referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. Time of intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cigarette smokers and aged 17 to 50 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention: Patients will be assigned to receive either curcumin (n=35) or placebo (n=35).
Main outcome variables
Nicotine dependence; depression; anxiety (primary outcome) and metabolic biomarkers (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170420033551N12
Registration date:2022-05-26, 1401/03/05
Registration timing:prospective
Last update:2022-05-26, 1401/03/05
Update count:0
Registration date
2022-05-26, 1401/03/05
Registrant information
Name
Amir Ghaderi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 771 7435
Email address
ghaderi-am@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-19, 1401/03/29
Expected recruitment end date
2022-07-31, 1401/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of curcumin on clinical and metabolic signs in cigarette smokers
Public title
Effect of curcumin in cigarette smokers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Smoking dependence (Fagerstrom test score more than 4)
Age of 17 to 50 years old
Complete informed consent
Exclusion criteria:
Unwillingness to cooperate
Taking curcumin, anti‐inflammatory and antioxidant supplements during the last 3 months before the intervention.
History of metabolic diseases including diabetes, hypertension, thyroid, and cardiovascular disease.
Pregnant women
Positive urine test for morphine, methamphetamine and cannabis
Use of psychiatric and neurological drugs such as benzodiazepines and antidepressants
Age
From 17 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. Supplements and placebos are only the code is written on the packages. Patients and researcher do not know the type of intervention and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Faculty of Medicine & Dentistry- Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.017
Health conditions studied
1
Description of health condition studied
Nicotine dependence in cigarette smokers
ICD-10 code
F17.21
ICD-10 code description
Nicotine dependence, cigarettes
Primary outcomes
1
Description
Nicotine Dependence Syndrome Scale
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
2
Description
Depression beck score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
3
Description
Anxiety beck score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Total glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
6
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
8
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
10
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
11
Description
VLDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
12
Description
LDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: In this group of patients (n=35) will be requested to take two Sina Curcumin capsules daily for 12 weeks (each capsules contain 40 mg curcumin). The Sina Curcumin capsules will be produced in the Nano Sina Elixir Company from curcuma.
Category
Treatment - Drugs
2
Description
Control group: In this group of patients (n=35) will be requested to take two placebo capsules daily for 12 weeks. The placebo capsules (Contain Starch) will be produced in the Nano Sina Elixir Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gholabchi Clinic (Shahid Beheshti and Matini hospital)
Full name of responsible person
Amir Ghaderi
Street address
Kashan
City
Shahid Rajaee Avenue, Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 4455 2200
Email
gaderiam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
gaderiam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
gaderiam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ph.D of addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
gaderiam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Dr. Amir Ghaderi is committed to presenting all the achievements of the project in accordance with the framework of the National Institute for Medical Research Development in the Islamic Republic of Iran.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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