Survey effectiveness of Combined Herbal Remedies with Bupropion on cigarette smoking in patients referring to quit cigarette clinic - A Randomized Clinical Trial
The Effect of Combined Herbal Remedies with Bupropion Discrimination on the Reduction of Smoking in Patients Referring to the Smoking cessation Clinic - A Randomized Clinical Trial
Determination of cigarette smoking in the bupropion-buprenorphine group.
Determine cigarette switching in the bupropion alone group.
Determine the change in consumption of bupropion for the smoker group in chamomile
Determination of the difference between smoking in both groups of bupropion and bupropion alone and bupropion with chamomile
Design
Clinical trials with a community-based control group with parallel, double-blind, accessible groups
Settings and conduct
In smoking cessation centers, municipal health centers in 1, 2 and 3 areas of Tehran, as well as the smoking cessation clinic of the anti-smoking community and random blocks were unaware of available participants in these centers.
Participants/Inclusion and exclusion criteria
Individuals aged 20 to 65 years old with more than 10 cigarettes per day and with a history of smoking for at least one year. Drug use is not recommended for the treatment of 5HT and drug monoamine oxidase inhibitors at least in the last two weeks. The result of the nicotine dependency test is over 6. without Advanced liver and kidney disease.
Intervention groups
A total of three groups were used in all groups: psychotherapy, behavioral therapy along with the use of bopropion 150 mg twice daily, in the second group with a herbal remedy for reducing and smoking cessation (Apple Health Number 568060 And also patent number 95179) contains four flowering herbs, mountain tea, lavender and green tea with equal proportions, and also in the third group, with chamomile cucumber, which has been shown to reduce the effects of smoking.
Main outcome variables
Reduction in the intake of smoke and quit smoking and reduce the symptoms of smoking cessation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180725040596N1
Registration date:2018-12-07, 1397/09/16
Registration timing:prospective
Last update:2018-12-07, 1397/09/16
Update count:0
Registration date
2018-12-07, 1397/09/16
Registrant information
Name
Nasir Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 5162
Email address
dehghan.n@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey effectiveness of Combined Herbal Remedies with Bupropion on cigarette smoking in patients referring to quit cigarette clinic - A Randomized Clinical Trial
Public title
Survey effectiveness of Combined Herbal Remedies with Bupropion on cigarette smoking in patients referring to quit cigarette clinic - A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They have a history of smoking for at least one year
The amount of cigarettes per person be more than 10 cigarettes per day
The age range is between 20 and 65 years old
The person taking the drug does not take a drug from group of drugs for marking the 5HT system
The person taking the drug does not take an inhibitor of manovin oxidase, at least in the last two weeks
The result of the nicotine dependency test is over than 6
Diagnosis is based on the indication of taking bupropion to help quit smoking
Exclusion criteria:
Do not have advanced liver disease
Do not have advanced kidney disease
Do not during pregnancy and breastfeeding
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants are divided into three groups that do not know which group uses combine herbal and herbal remedies in chamomile. Also, the analyst and data monitoring officer from this group of uninformed clients Will remain unaware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research in School of Medicine, Iran University of Medical Sciences
Street address
13th Floor, Block A, between South Felamak and Zarafshan, Iran-Iran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.IUMS.FMD.REC.1397.022
Health conditions studied
1
Description of health condition studied
Nicotine dependence
ICD-10 code
F17.2
ICD-10 code description
Nicotine dependence
Primary outcomes
1
Description
Reduce smoking in people with moderate to severe nicotine addiction
Timepoint
For six weeks, visits every two weeks (with an initial visit of a total of 4 turns)
Method of measurement
Checklist and interview with participant
2
Description
Reduce the symptoms of smoking cessation
Timepoint
For six weeks, visits every two weeks (with an initial visit of a total of 4 turns)
Method of measurement
Checklist and interview with participant
Secondary outcomes
1
Description
Reduce Symptoms Caused by Cigarette Smoking
Timepoint
For six weeks, visits every two weeks (with an initial visit of a total of 4 turns)
Method of measurement
Checklist and interview with the participant
Intervention groups
1
Description
Intervention group: Psychotherapy, Behavioral Therapy along with Bopropion 150 mg twice daily plus twice daily (morning and evening) herbal remedies for reducing intake and smoking cessation.
Category
Treatment - Drugs
2
Description
Intervention group: Using twice daily 150 mg bupropion tablet with psychotherapy and behavioral therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Centers for smoking cessation of municipal health houses in District 1
Full name of responsible person
Nasir Dehghan
Street address
Ghods Square, Beginning of Shahid Bahonar Street
City
Tehran
Province
Tehran
Postal code
11111111111
Phone
+98 21 9602 7000
Email
dehghan.n@tak.iums.ac.ir
2
Recruitment center
Name of recruitment center
Centers for smoking cessation of municipal health houses in District 2
Full name of responsible person
Nasir Dehghan
Street address
Sa'atat Abad, Shahid Tehrani Moghadam Square (Pine), West Ceder Blvd, Dr. Qaisar Aminpour Blvd, West Thirteenth Avenue
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 9603 2000
Email
dehghan.n@tak.iums.ac.ir
3
Recruitment center
Name of recruitment center
Centers for smoking cessation of municipal health houses in District 3
Full name of responsible person
Nasir Dehghan
Street address
Tehran, Shariati Avenue, lower than Hosseiniyeh Ershad
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 9601 3000
Email
dehghan.n@tak.iums.ac.ir
4
Recruitment center
Name of recruitment center
Tobacco Control Research Center of the Counter-Narcotics Counterfeit Population of Iran