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CTRI Number  CTRI/2025/01/078886 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role Of Homoeopathy In Chronic Anxiety 
Scientific Title of Study   To Study The Cases Of Generalized Anxiety Disorder In Light Of Aphorism 225 With Practical Implementation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Binita Ashokbhai Chauhan 
Designation  M D Scholar Part 2 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Organon Of Medicine and Homoeopathic Philosophy Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9537534020  
Fax    
Email  binitachauhan2303@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Snehaben Ajitkumar Patel 
Designation  Associate Professor Organon Of Medicine And Homoeopathic Philosophy Department 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Organon Of Medicine and Homoeopathic Philosophy Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9428392287  
Fax    
Email  snehugopi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Snehaben Ajitkumar Patel 
Designation  Associate Professor Organon Of Medicine And Homoeopathic Philosophy Department 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Organon Of Medicine and Homoeopathic Philosophy Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9428392287  
Fax    
Email  snehugopi@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Anand Mangal Society Udhana Magdalla Road Surat 395001 Gujarat India 
Peripheral Centre and regular camp visit of C D Pachchigar College of Homoeopathic medicine and hospital 
 
Primary Sponsor  
Name  C D Pachchigar College Of Homoeopathic Medicine And Hospital  
Address  C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Anand Mangal Society Udhana Magdalla Road surat 395001  
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 Binita Ashokbhai Chauhan  C D Pachchigar College Of Homoeopathic Medicine And Hospital  Department Of Organon Of Medicine and Homoeopathic Philosophy Division Of MD 2nd floor
Surat
GUJARAT 
9537534020

binitachauhan2303@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: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicines   Homoeopathic Medicine Dose As Per Requirement Of Case Through Sublingual Mode Of Administration Within Time Duration Of 9 Month 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Who Fit Under The Criteria Of DSM-5 For Generalized Anxiety Disorder 
 
ExclusionCriteria 
Details  Patient With Autoimmune Disease And Irreversible Pathology
Critically Ill Patients
Patients With Somato-Psychic Complains
Not Follow The Criteria Of DSM-5 For Generalized Anxiety Disorder 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Role Of Homoeopathy In Management Of Generalized Anxiety Disorder  9 Month 
 
Secondary Outcome  
Outcome  TimePoints 
Study The Practical Applicability And Co-relation Of Apho-225 Mention
In Organon Of Medicine By Master Hahnemann Through The Cases Of Generalized Anxiety Disorder 
9 Month 
 
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)   28/01/2025 
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  


BRIEF RESUME OF INTENDED WORK

 


 

NEED  FOR THE STUDY

 

·         Every coin has two sides, this is same apply for anxiety, in one side anxiety is become a progenitor of success and in other hand it can be destroy everything. Anxiety is not necessarily a bad thing, it can help us to stay alert, aware of risk and motivate us to solve a problem. But when it goes out of control and start interfering in life than it become a problem. It is very scary to imagine that anxiety controlling us and we are helpless. It is like we put the key of our happiness in someone else pocket. That’s why control over them is needed. In any battle if we want to win, we know our enemy very well. Especially when the enemy is invisible, study is more important.

·         In all over India 40 million people suffering from anxiety disorder & 6.8 million adult suffer from generalized anxiety disorder. (1) And this number increase day by day. This numbers catch the attention. Not just a number but how this disease affect the quality of human life it is more important. Generalized anxiety disorder not limited to mental sphere but also affect the physique.

·         This disease gets benefits of system also, unawareness in patient regarding psychosomatic concept because medicine has historically separated disease in to mind or the body. Those who silently suffering with physical complains & unaware about their internal derangement. People are still not expressive about their mental disturbance. People are afraid of being called as a mad man. In this type of disease role of homoeopathy is so important. Because homoeopath see patient as a whole individual. Master Hahnemann understands the role of mind in disease. Master Hahnemann clearly stated that “emotional disease can derange the physical health in aphorism 225 in organon of medicine”.

“The body achieves what the mind believes”- Nepoleon hill

·         So beautifully Master Hahnemann explained mental disease years back with classification. That’s why as a student of homoeopathy not a need but it is necessary to shifting our focus on knowing to applying the things which is written in organon of medicine. It is the main aim of the research to study the one aphorism of organon of medicine was written years back how to apply in most prevalence disease of modern world. That’s why here my title is to study the cases of generalized anxiety disorder in light of aphorism 225 with practical implementation.

 

 

 

 


REVIEW OF LITERATURE:

 

Anxiety is a normal phenomenon, characterised by apprehension due to anticipation of danger. Normal anxiety becomes pathological when it causes significant subjective distress or impairment in the functioning of an individual. (2)

GAD is a chronic condition characterised by excessive, uncontrollable and often irrational worry about everyday things, accompanied by a variety of somatic symptoms that cause significant impairment in social or occupational functioning or marked distress in the patient.  (2) (3)

 

DEFINITION:-

·         Generalized anxiety disorder is defined as excessive anxiety and worry about a number of events or activities at least for 6 month and most of days. (4)

 

EPIDEMIOLOGY

·         Generalized anxiety disorder is most common type of anxiety disorder, affecting 6.8 million adult or 3.1% India populations  (1)

·         GAD is often estimated to affect approximately 3–6% of adults. (5)

·         It is more common in female than in male (4)

·         The prevalence of the diagnosis peaks in middle age and declines across the later years of life  (4)

ETIOLOGY:-

1.    Temperamental (4) and personality  (3)

2.    Environmental factor (4)  and Life Experience (6)

3.    Genetics (4)

4.    Brain structures (6)

5.    Lifestyle and social factor  (6)

CLINICAL/DIAGNOSTIC FEATURES:-

·         The essential characteristics of generalized anxiety disorder are sustained and excessive anxiety and worry accompanied by either motor tension or restlessness.  (7)

·         Intensity, duration & frequency of anxiety and worry out of proportion. (4)

·         Individual finds it is difficult to control worry and to keep worrisome thoughts from interfering with attention to tasks at hand. (4)

·         Worries associated with generalized anxiety disorder are more pervasive, pronounced and distressing, have a longer duration and frequency occur without precipitant. (4)

DSM-5 DIAGNOSTIC CRITERIA FOR GENRALIZED ANXIETY DISORDER (4)

A. Excessive anxiety and worry (apprehensive expectation), occurring more days than not for at least 6 months, about a number of events or activities.

B. The individual finds it difficult to control the worry

C. The anxiety and worry are associated with three (or more) of the following six symptoms (with at least some symptoms having been present for more days than not for the past 6 months):

1.    Restlessness or feeling keyed up or on edge.

2.    Being easily fatigued.

3.    Difficulty concentrating or mind going blank.

4.    Irritability.

5.    Muscle tension.

6.    Sleep disturbance

 D. The anxiety, worry, or physical symptoms cause clinically significant distress or impairment in social, occupational, or other areas of functioning.

 E. The disturbance is not attributable to the physiological effects of a substance

 F. The disturbance is not better explained by another medical disorder.

 

TREATMENT  (7) (5)

1.    Psychotherapy.

·         Cognitive behavioural therapy(CBT)

2.    Pharmacotherapy

·         Selective serotonin reuptake inhibitor(SSIR)

·         Benzodiazepines, venlaflexine

 

MASTER HAHNEMANN AND MENTAL DISEASES

 

·         Master Hahnemann gives a much attention to mental diseases. He sees the mentally ill patient as a whole sick individual who need proper care and treatment. In organon of medicine aphorism 210 to 230 mental diseases are mentioned. The psychosomatic diseases mentioned in aphorism 225 in this aphorism he states that the physique slightly changed or indisposed by psychological causes such as continued anxiety, worry vexation, stress and long lasting excessive fear and fright. These psychological diseases affect the physical health & may affect the physique in high degree. (8)

·          APHORISM 225-“There are, however, as has just been stated, certainly a few emotional diseases which have not merely been developed into that form out of corporeal diseases, but which, in an inverse manner, the body being but slightly indisposed, originate and are kept up by emotional causes, such as continued anxiety, worry, vexation, wrongs and the frequent occurrence of great fear and fright. This kind of emotional disease in time destroys the corporeal health, often to a great degree”  (9)

 

APHORISM 225 AND GENREALIZED ANXIETY DIOSRDER

·          Here the generalized anxiety disorder itself a chronic emotional disease and also include the somatic symptoms. So this somatic symptoms not the associated features but developed due to the chronic anxiety. But how it affected?

·         Several regions of the brain that mediate the processing of stimuli associated with fear, anxiety, memory, and emotion like amygdala, insula and frontal cortex. In the amygdale there is a basolateral amygdala complex recognizes sensory information and activates GABAergic neurons which can cause somatic symptoms of anxiety. GABAergic neurons control the nervous system by reducing feelings of stress, anxiety, and fear. When there is inadequate number of GABAergic neurons, those negative feelings become apparent and can release somatic responses of stress. (5)

·         Homoeopathy treats the patient as a whole in mental and physical plane together based on symptom similarity. Homoeopathy rejects mind-body duality. According to the homoeopathic principle, mind and body are dynamically interconnected and all chronic diseases, if studied carefully, will show decided & characteristic mental symptoms long before physical changes can be discovered in the body. (10)

 

HOMOEOPATHIC MANAGEMENT (9)

1.    In APHORISM 226- Master Hahnemann advice to give psychological therapies and give counselling to patients.

           Display of confidence –behavioural therapy

           Interpersonal therapy- friendly exhortations and sensible advice.

It is apply in cases when it recent origin and not damage corporeal health to a great degree.

 

2.    APHORISM 227, when the fundamental cause in case is psoric miasm. In this case anti psoric treatment is required.

 

VIEWS OF PIONEERS- (11)

·         J T KENT- Mind is the centre of the whole functioning of the organism and that it is also the focal point from which the disease process starts.

·         WILLIAM BOERICKE- Mental states & emotions are evident primary causes or contributing factors to the production or continuance of disease.

·         C. M. BOGER- The relative time for the appearance of each symptom naturally varies with the speed of the disease. From, this we reason that the earliest mental manifestations are decidedly the most important of all symptoms.

 

 

 

 


OBJECTIVE OF STUDY

 

1.    To show the practical applicability and co-relation of apho-225 mention in organon of medicine by Master Hahnemann through the cases of generalized anxiety disorder.

2.    Understand the clinical presentation of generalized anxiety disorder.

3.    Role of homoeopathic in managing generalized anxiety disorder and in improving quality of life.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


MATERIAL AND METHOD

 


SOURCE OF DATA

Project site:

1.    O.P.D & I.P.D of C. D. Pachchigar College of Homoeopathic Medicine & Hospital; Near Navjivan Circle, Udhana Magdalla Road, Surat. 395001

2.    Peripheral centre O.P.D allotted By C.D.Pachchigar College of Homoeopathic Medicine & Hospital; Near Navjivan Circle, Udhana Magdalla Road, Surat. 395001


MATERIAL

      Materials utilized in study consist of-

1.   Standard case taking format of C.D.Pachchigar College of Homoeopathic Medicine & Hospital; Near Navjivan Circle, Udhana Magdalla Road, Surat. 395001

2.   Homoeopathic computer software: ZOMEO (version 13.8.0)

3.   Books- psychiatry, organon of medicine, psychology, materia medica, & repertory. All homoeopathic and allied literature related to my topic &

Soft or hard research material.

4.   Scale- Hamilton anxiety scale.

 


METHOD OF COLLECTION OF DATA

·         Study design-  Prospective Analytical study

·         Sample size- 30 cases

·         Sample technique- simple randomized

·         Study duration- 9 month

·         Selection criteria-

Inclusion criteria-

1)    Who fit under the criteria of DSM-5 for generalized anxiety disorder

2)    Both sex

3)    Age group above 20 years

 

Exclusion criteria-

1)    Patient with autoimmune disease and irreversible pathology.

2)    Critically ill patients.

3)    Patients with Somato-psychic complains

4)    Not follow the criteria of DSM-5 for generalized anxiety disorder.

 

·         Case taking will be done according to guidelines mentioned by Dr. Hahnemann in Aphorisms 83-104 & College O.P.D standard case taking format.

·         After proper analysis and evaluation of symptoms, totality of symptoms will be formed.

·         Totality formation will be done as per the instructions given by Dr. Hahnemann in organon of medicine.

·         Investigations for diagnosis of the disease will be done as per the requirement of the case.

·         The remedy will be selected on the basis of totality of symptoms and either from reportorial or non-reportorial approach.

·         The remedies will be used in various potency as per the requirement of the cases.

·         Remedies will be administered as per guidelines given by Dr. Hahnemann in organon of medicine.

·         The remedies will be repeated as per the requirement of the case.

·         Homoeopathic remedies will be dispensed from C. D. Pachchigar College of Homoeopathic Medicine & Hospital; Near Navjivan Circle, Udhana Magdalla Road, Surat. 395001

 

·         Response will be analysed in to 3 criteria-

1.    Significance improvement –

General improvement at all levels with the feeling of well being both mentally and physically with disappearance of the presenting symptoms.

2.    Mild  improvement-

General senses of well being with reduce in intensity and duration of presenting symptoms.

3.    Not improved –

A complain will continue to progress.

 

 


 

DOES THE STUDY REQUIRING ANY INVESTIGATION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

 

 

 

AS PER REQUIREMENT OF THE CASE

 


 

HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTE?

 

 

YES

 

 

 


BIBLIOGRAPHY

 

1.

www.maxlab.co.in. [Online].; 2022 [cited 2024 1 27. Available from: https://www.maxlab.co.in/blogs/anxiety-disorder-causes-symptoms-treatment-and-prevention.

2.

moorthi k, p r. Homoeopathy in Management of Generalized Anxiety Disorder : A Case Report. indian journal of research in homoeopathy. 2023 Mar 24; 17(1).

3.

Ankita. article on generalized anxiety disorder(GAD). international journal of science and research. 2020 Nov; 9(11).

4.

Association AP. Diagnostic and Statistical Manual of Mental Disorders (DSM-5). In. ARLINGTON: American Psychiatric Publishing; 2013. p. 222-225.

5.

WC. Wikipedia. [Online].; 2019. Available from: https://en.wikipedia.org/wiki/Generalized_anxiety_disorder.

6.

will meek P. www.verywellmind.com. [Online].; 2018 [cited 2024 1 27. Available from: https://www.verywellmind.com/gad-causes-risk-factors-1392982.

7.

sadock BJ, sadock VA, ruiz p. Kaplan & Sadock’s Synopsis of psychiatry: Behavioral sciences/clinical Psychiatry. 11th ed. Philadelphia: Wolters Kluwer; 2015. p. 407-412.

8.

sv dg, rj dv, p di. An overview of psychosomatic diseases and homoeopathy. International Journal of Homoeopathic Sciences. 2022 Oct; 6(4): p. 147-149.

9.

hahnemann S. Organon of medicine. 6th ed. new delhi: indian books and periodical publishers; 2013. p. 239-240.

10.

Thakur T. The Concept of Mind and Treatment of Mental Diseases in Homoeopathy. Journal of AYUSH: Ayurveda, Yoga,Unani ,Siddha and Homeopathy. 2022 Mar; 11(1): p. 1-5.

11.

Samaran DR, Vivek dr. Concept of psychosomatic disorders in homoeopathy. International Journal of Homoeopathic Sciences. 2020 Jun; 4(2).

 

 


 
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