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CTRI Number  CTRI/2024/07/070377 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 29/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A study to understand the role of homoeopathic medicine in treating people with tobacco addiction.  
Scientific Title of Study   A Prospective study on the effectiveness of Plantago major tincture in reducing craving for tobacco assessed using Fagerstrom Nicotine dependence scale 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sabari sindhu R 
Designation  PG Scholar 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  4th floor, Department of Psychiatry, Sarada Krishna Homoeopathic medical college, Kulasekharam, Kanniyakumari district, Tamil nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9894513932  
Fax    
Email  sabarisindhur3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subi P R 
Designation  Professor 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  4th floor, Department of Psychiatry, Sarada Krishna Homoeopathic medical college, Kulasekharam, Kanniyakumari district, Tamil nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9486863644  
Fax    
Email  drsubinair@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Subi P R 
Designation  Professor 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  4th floor, Department of Psychiatry, Sarada Krishna Homoeopathic medical college, Kulasekharam, Kanniyakumari district, Tamil nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9486863644  
Fax    
Email  drsubinair@gmail.com  
 
Source of Monetary or Material Support  
Institution-Sarada Krishna Homoeopathic Medical College, Kulasekharam ,kanniyakumari district ,tamil nadu, India, 629161 
 
Primary Sponsor  
Name  Post Graduate research funded by College 
Address  Sarada Krishna Homoeopathic Medical College, Kulasekharam ,kanniyakumari district ,tamil nadu, India, 629161 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSabari sindhu R  Sarada Krishna Homoepathic Medical College   Department of Psychiatry, Room no: 510 Sarada Krishna Homoeopathic Medical College, Kulasekharam ,kanniyakumari district ,Tamil nadu, India, 629161
Kanniyakumari
TAMIL NADU 		 9894513932

sabarisindhur3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F172||Nicotine dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  PLANTAGO MAJOR  Plantago Major Mother Tincture 10 drops in 30ml aqua three times per day will be given , during the course of treatment and repetition will be assessed based on the improvement. Pre and Post assessment will be done using FNDT Scale. Duration of study is 1 year 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  64.00 Year(s)
Gender  Male 
Details  Patients diagnosed with Nicotine Tobacco Addiction according to ICD 10. Patient under the age group of 19-64 years. Only Male patients are included. 
 
ExclusionCriteria 
Details  Patients with Co morbid psychiatric disorders requiring immediate attention.Those who are unable to understand or comply with the study procedures. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The effectiveness of Homeopathic medicine plantago major tincture in nicotine addicted adult males will be assessed using Fagerstrom nicotine depenedence scale.  one year 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   10/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
 Tobacco use is one of the leading preventable causes of death globally in this modern era. Hence a comprehensive approach is required to tackle tobacco dependence, encompassing prevention, intervention, and support strategies. Nicotine ,the primary psychoactive component in tobacco products, leads to the development of dependence and addiction in susceptible individuals .Different form of  tobacco Product include  cigerettes, chewing tobacco, and wet and dry snuff and dried leaves from the tobacco, these products will be included in my study.
 In the practice of homoeopathy, plantago major,has been studied for its potential effects on nicotine addition. While there is limited scientific evidence specifically focused on plantago major tinctures efficacy in treating nicotine addition, This study, includes the global situation of nicotine addiction associated health consequences assessd by fager strom nicotine dependence scale. An effort is also made to explore evidence based strategies for prevention and cessation, along with recommdations for policy initiatives and community based interventions.
 Plantago major produces disgust for tobacco in chewers as well as it cures neuralgia resulting from tobacco.
Plantago is indicated for “nicotinism”, the historical term applied to tobacco craving, and in its mother tincture form, has been found to produce an aversion to tobacco. The study will be conduted for a period of 1 year.
 
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