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IRCT20170420033551N12 IRCT 2022-05-26 Kashan University of Medical Sciences Effect of curcumin in cigarette smokers The Effects of curcumin on clinical and metabolic signs in cigarette smokers 2022-06-19 anticipated 70 Complete https://irct.ir/trial/63736 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Nicotine dependence in cigarette smokers. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Amir Ghaderi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 gaderiam@yahoo.com Kashan University of Medical Sciences scientific Amir Ghaderi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 gaderiam@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Smoking dependence (Fagerstrom test score more than 4) Age of 17 to 50 years old Complete informed consent 17 years 50 years Both 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 F17.21 Nicotine dependence, cigarettes Treatment - Drugs Placebo 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. 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. Nicotine Dependence Syndrome Scale. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Depression beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Anxiety beck score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Kashan University of Medical Sciences Approved 2022-05-07 Research Ethics Committees of Faculty of Medicine & Dentistry- Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)