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CTRI Number  CTRI/2025/07/091315 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A Study on the Role of Homoeopathy in Tobacco Smoking induced Anxiety in Adults.  
Scientific Title of Study   To Study Anxiety Induced by Tobacco Smoking in Adults and its Homoeopathic Management.  
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 Shivani Ashwinkumar Mamkhau 
Designation  MD Scholar Part-2 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  2nd Floor Department of Psychiatry Post Graduation Division Room No 302 C D Pachchigar College of Homoeopathic Medicine Near Navjivan Circle Udhana Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9726259072  
Fax    
Email  shivanimamkhau2596@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepti Yesade 
Designation  Professor of Homoeopathy Psychiatry 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  2nd Floor Department of Psychiatry Post Graduation Division Room No 302 C D Pachchigar College of Homoeopathic Medicine Near Navjivan Circle Udhana Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  940803599  
Fax    
Email  deepti.yesade81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepti Yesade 
Designation  Professor of Homoeopathy Psychiatry 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  2nd Floor Department of Psychiatry Post Graduation Division Room No 302 C D Pachchigar College of Homoeopathic Medicine Near Navjivan Circle Udhana Magdalla Road Surat 2nd Floor Department of Psychiatry C D Pachchigar College of Homoeopathic Medicine Near Navjivan Circle Udhana Magdalla Road Surat 395001

Surat
GUJARAT
395001
India 
Phone  940803599  
Fax    
Email  deepti.yesade81@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhana Magdalla Road Surat 395001 Gujarat India  
 
Primary Sponsor  
Name  C D Pachchigar College of Homoeopathic Medicine And Hospital 
Address  C D Pachchigar College of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhana Magdalla Road Surat 395001 Gujarat India  
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 
Dr Shivani Mamkhau  C D Pachchigar College of Homoeopathic Medicine And Hospital  2nd Floor Department of Psychiatry Post Graduation Division Room No 302 C D Pachchigar College of Homoeopathic Medicine Near Navjivan Circle Udhana Magdalla Road Surat 395001
Surat
GUJARAT 
9726259072

shivanimamkhau2596@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Of C. D. Pachchigar College Of Homoeopathic Medicine and Hospital  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 
Intervention  Homoeopathic Medicine  Homoeopathic Medicine as per requirement of case in duration of 9 months 
Comparator Agent  Not Apllicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1 Patient covering DSM 5 criteria for Substance induced Anxiety disorder.
2 Adults of all the socio economical status will be included.
 
 
ExclusionCriteria 
Details  1 Below 18 and above 45 years of age group is excluded.
2 Individuals already on anti anxiolytics.
3 Individuals with other substance abuse.
4 Individuals with Co morbid conditions like Cardiovascular diseases(Stroke, Heart disease, Peripheral vascular disease), Respiratory disease (Asthma, COPD, Lung Cancer), Cancer, Type 2 DM, Hypertension that can be exacerbated due to smoking will be excluded.
5 Individuals having habit of chain smoking will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess the role of Homoeopathy in anxiety due to tobacco use.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Identify risk factors of anxiety among adult smokers.
Reduce recurrence of anxiety episodes in tobacco users.
 
6 months 
 
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   N/A 
Date of First Enrollment (India)   01/08/2025 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

 6 BRIEF RESUME OF INTENDED WORK

 

6-1 NEED FOR STUDY

The detrimental effects from smoking on health are well known and mortality attributable to smoking is high

Studying anxiety in tobacco smoking adults is crucial for understanding the complex relationship between mental health and substance use It can shed light on how anxiety influences smoking behavior and vice versa informing targeted interventions and treatment approaches for individuals struggling with both issues

Smoking has been found to be associated with a wide range of mental disorders

In World Health Organization surveys daily smoking is reported by 30 percent of the population in the western world

Epidemiological studies have found that people with a mental disorder are twice as likely to smoke compared to the general population and are high consumers of cigarettes

Considering the most prevalent mental disorders associations between depression and smoking have been shown repeatedly but more recent work has also highlighted the importance of anxiety disorders

Homoeopathy is based on the principle like cures like also known as Law of Similars

Homoeopathy places a strong emphasis on individualization in treatment aiming to identify the characteristics of each persons symptoms rather than solely focusing on symptom management The approach seeks to understand and address the underlying causes of symptoms aligning with a holistic perspective of treatment Exploring the effectiveness of homoeopathic management in treatment of Anxiety ultimately benefiting the homoeopathic fraternity

 

6-2 REVIEW OF LITERATURE

INTRODUCTION

Anxiety Disorders include disorders that share features of excessive fear and anxiety and related Behavioral disturbances Fear is the emotional response to real or perceived imminent threat where as anxiety is anticipation of future threat

Substance induced anxiety disorder involves anxiety due to substance intoxication or withdrawal Substance use is globally prevalent and remains an intractable public health problem for healthcare systems Substance use poses a significant threat to the health and the social and economic aspects of families communities and nations

The tobacco epidemic is one of the biggest public health threats the world has ever faced killing over 8 million people a year around the world More than 7 million of those deaths are the result of direct tobacco use while around 13 million are the result of nonsmokers being exposed to secondhand smoke Cigarette smoking is the most common form of tobacco use worldwide

Nicotine exerts complex effects on neurotransmitter systems influencing mood and anxiety levels

1 Dopamine DA – Reward and Addiction

Short Term Nicotine stimulates nicotinic acetylcholine receptors nAChRs leading to dopamine release in the brains reward pathways producing feelings of pleasure and relaxation

Long Term Chronic nicotine use can deplete dopamine levels contributing to dependence and withdrawal symptoms including increased anxiety

2 Serotonin 5HT – Mood Regulation

Short Term Nicotine increases serotonin release temporarily enhancing mood

Long Term Prolonged nicotine exposure may lead to serotonin receptor desensitization reducing its natural anxiety relieving effects and potentially heightening anxiety and depressive symptoms

3 Norepinephrine NE – Stress Response

Short Term Nicotine stimulates norepinephrine release increasing alertness and arousal

Long Term Chronic stimulation can overactivate the stress response leading to restlessness and heightened anxiety

India being the second largest consumer of tobacco in the world there is an urgent need to reverse this entirely preventable epidemic Hence tobacco cessation should be a priority area of research in India

In the International Classification of Diseases 11th Revision ICD11 anxiety disorders induced by tobacco smoking are classified under 6C4A Disorders due to use of nicotine

 

CLINICAL PRESENTATION

A Panic attacks or anxiety is predominant in the clinical picture

B There is evidence from the history physical examination or laboratory findings or both 1 and 2

1 The symptoms in Criterion A developed during or soon after substance intoxication or withdrawal

2 The involved substance is capable of producing the symptoms in Criterion A

C The symptoms should not be better explained by a preexisting anxiety disorder unrelated to substance use Such evidence of an independent anxiety disorder could include the following The symptoms precede the onset of the substance use the symptoms persist for a substantial period of time for example about 1 month after the cessation of acute withdrawal or severe intoxication or there is other evidence suggesting the existence of an independent nonsubstance medication induced anxiety disorder for example a history of recurrent nonsubstance medication related episodes

D The disturbance does not occur exclusively during the course of a delirium

E The disturbance causes clinically significant distress or impairment in social occupational or other important areas of functioning

 

DIFFERENTIAL DIAGNOSIS

Other Substance Intoxication and Substance Withdrawal

Anxiety Disorder not due to Substance Intoxication and Substance Withdrawal

Delirium

Anxiety Disorder due to another medical condition

 

HOMOEOPATHIC APPROACH

Mental diseases of Psychosomatic type Aphorism 225 Mental diseases that arise as a result of prolonged emotional disturbances and different psychological depressions like continued anxiety worry vexation wrongs and frequent occurrence of greater fear and fright Such diseases may be of recent origin and may not have developed fully into corporeal diseases But if left untreated they may damage the body

According to aphorism 215 and 216 Hahnemann considers mental disease as one sided diseases of the chronic type affecting the whole psychosomatic entity

Common suitable homeopathic drugs for Anxiety associated with tobacco smoking

Arsenicum album Aesclepias tuberosa Caladium seguinum Ignatia amara Lobelia inflata Nux vomica Petroleum Plantago major Strophanthus hispidus Tabacum Sepia Symphytum Etc

 

6-3 OBJECTIVES OF STUDY

1 To assess the role of Homoeopathic Medicines in the Anxiety disorder due to Tobacco Smoking in Adults

2 To identify risk factors contributing to anxiety in adults who smoke tobacco

3 To reduce recurrent Anxiety episodes in tobacco smokers

 

7 MATERIALS AND METHODS

7-1 SOURCE OF DATA

OPD of CD PACHCHIGAR Homoeopathic college and hospital

Peripheral centre and regular camp visit of CD PACHCHIGAR Homeopathic medical college and hospital

Data will be collected via interview processes this process includes guidelines mentioned in the organon of medicine and case taking will be done with reference to aphorisms number 83 to 104 as explained by Dr Sammuel Hahnemann

 

7-2 MATERIAL

Textbooks of Psychiatry Book of organon of medicine philosophy Materia medica repertory all homoeopathic books and literature related to topic software and soft or hard research material

 

7-3 METHOD OF COLLECTION OF DATA

1 Study type - Experimental study

2 Study design - Prospective study

3 Study population - Patients from OPD of C D Pachchigar Homoeopathic Hospital and from peripheral OPDs

4 Sample size - 30 patients

5 Sampling techniques - Non Probability Purposive Sampling

6 Study duration - 9 months

7 Selection criteria

Inclusion criteria

1 Patient covering DSM5 criteria for Substance induced Anxiety disorder

2 Patient of 18 to 45 years of age group

3 Adults of all the socio economical status will be included

4 Both sex will be included

 

Exclusion criteria

1 Below 18 and above 45 years of age group is excluded

2 Individuals already on anti anxiolytics

Individuals with other substance abuse

4 Individuals with Comorbid conditions like Cardiovascular diseases Stroke Heart disease Peripheral vascular disease Respiratory disease Asthma COPD Lung Cancer Cancer Type II DM Hypertension that can be exacerbated due to smoking will be excluded

5 Individuals having habit of chain smoking will be excluded

 

Data analysis and methods

Scale - Hamilton Anxiety Scale

Improved - Subjects showing a clinically marked decreased in score of the respective scale with decrease in craving of tobacco smoking

Not Improved - No clinically favourable improvement after medicinal interventions Adults with aggravated scores in their respective scoring scales

Left the treatment - Subjects who will not maintain followups till advised to discontinue treatment

 

7-4 DOES THE STUDY REQUIRE ANY INVESTIGATION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS

The diagnosis of the case will be done on the basis of the case history and clinical findings Special investigations will be done as and when required

 

7-5 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTE

YES

 

8 BIBLIOGRAPHY

 

1 Hughes JR HDJDL Am J Psychiatry Online 1986 Available from httpsdoiorg101176ajp1438993

2 Organisation WH Geneva WHO Online 2024 Available from httpswwwwhointnewsroomfactsheetsdetailtobacco

3 Lasser K BJWSHDMDBD Online 2002 Available from httpsdoiorg101001jama284202606

4 S H Organon of Medicine In B Jain Publishers 2002 p 6970

5 Association AP Diagnostic and Statistical manual of mental disorders 5th ed 2022

6 Sukumar GM BPDVNSVSBAea Online 2022 Available from httpsdoiorg1018332tpc155190

7 Dani JA BD Online 2007 Available from httpsdoiorg101146annurevpharmtox47120505105214

8 Benwell ME BDAJ Online 1988 Available from httpsdoiorg101111j147141591988tb10614x

9 Fuxe K AKEPHAAL Online 1989 Available from httpsdoiorg10160306453089900042

10 Organisation WH International Classification of Diseases 11th revision ICD11 Geneva WHO 2022

11 Boericke WB Materia Medica with Repertory B Jain Publishers 2007

 

 
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