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临床试验/CTRI/2025/07/091315
CTRI/2025/07/091315尚未招募不适用

To Study Anxiety Induced by Tobacco Smoking in Adults and its Homoeopathic Management.

C D Pachchigar College of Homoeopathic Medicine And Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Assess the role of Homoeopathy in anxiety due to tobacco use.

研究概览

简要总结

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

3 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

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 1 Patient covering DSM 5 criteria for Substance induced Anxiety disorder.
  • 2 Adults of all the socio economical status will be included.

排除标准

  • 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.

结局指标

主要结局

Assess the role of Homoeopathy in anxiety due to tobacco use.

时间窗: 6 months

次要结局

  • Identify risk factors of anxiety among adult smokers.(Reduce recurrence of anxiety episodes in tobacco users.)

研究者

发起方
C D Pachchigar College of Homoeopathic Medicine And Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shivani Ashwinkumar Mamkhau

C D Pachchigar College Of Homoeopathic Medicine And Hospital

研究点 (1)

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