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CTRI Number  CTRI/2024/06/068422 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic Medicine for Mental health 
Scientific Title of Study   A Prospective Study On Understanding And Application Of Aphorism 225 In Cases Of Generalised Anxiety Disorders  
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 Vijay amipara 
Designation  Pg Scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Organon Of Medicine And Homoeopathic Philosophy Rajkot Homoeopathic Medical College,Parul university, behind jainath complex, makkam chowk, gondal road, rajkot
Department of Organon Of Medicine And Homoeopathic Philosophy Rajkot Homoeopathic Medical College,Parul university, behind jainath complex, makkam chowk, gondal road, rajkot
Rajkot
GUJARAT
360002
India 
Phone  9979287705  
Fax    
Email  vijayamipara@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Shroff 
Designation  Professor and HOD of department of organon of medicine and homoeopathic philosophy 
Affiliation  Rajkot Homoeopathic Medical college 
Address  Department of organon of medicine and homoeopathic philosophy room no.103,Rajkot Homoeopathic Medical College, Parul University, behind jaynath complex, makkam chowk,Gondal road, Rajkot
Department of organon of medicine and homoeopathic philosophy,Rajkot Homoeopathic Medical College, Parul University, behind jaynath complex, makkam chowk,Gondal road, Rajkot
Rajkot
GUJARAT
360002
India 
Phone  9898930311  
Fax    
Email  drshroff3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijay amipara 
Designation  PG Scholar 
Affiliation  Rajkot homoeopathic medical college 
Address  Department of organon of medicine and homoeopathic philosophy, Rajkot homoeopathic medical college, Parul unniversity, behind jainath complex, makkam chowk, gondal road,rajkot 360002
Department of organon of medicine and homoeopathic philosophy, Rajkot homoeopathic medical college, Parul unniversity, behind jainath complex, makkam chowk, gondal road,rajkot 360002
Rajkot
GUJARAT
360002
India 
Phone  9979287705  
Fax    
Email  vijayamipara@gmail.com  
 
Source of Monetary or Material Support  
Rajkot homoeopathic medical college,parul university, Rajkot 360002, Gujarat, India 
 
Primary Sponsor  
Name  Rajkot Homoeopathic Medical college Parul University 
Address  behind jainath complex,makkam chowk,gondal road, rajkot 360002 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NA  not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr vijay amipara  Sainath Homoeopathic Hospital Attached with Rajkot Homoeopathic Medical College  Rroom no. 103,Department Of Organon of Medicine and Homoeopathic Philosophy , Rajkot Homoeopathic Medical College, Parul University, behind jaynath complex, makkam chowk,Gondal road, Rajkot 360002
Rajkot
GUJARAT 
9979287705

vijayamipara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research- Rajkot Homoeopathic Medical College (RHMC ), Parul University, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F409||Phobic anxiety disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  application of aphorism 225 in cases of generaliised anxiety  Medicine Based on The Totality Of Symtoms, Similimum Medicine single dose, Use either 30,200 or,1m potency and every 30 days repetation if requirement based on patients susceptibility 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Belonging to the age group 21-60 years.
Pre Diagnosed cases of GAD.
People of both sexes.
People of Different socio-economic status will be considered for the study.
 
 
ExclusionCriteria 
Details  Cases with irreversible, pathological conditions where surgical intervention is needed.
Patients having any other severe systemic diseases like HTN, DM, and CKD etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
there will be some improvement in Anxiety Attacks, symptoms after Prescribing Homoeopathic Medicine   There will Be Some Improvement in Anxiety Attack in 4 weeks After Prescribing Homoeopathic Medicine  
 
Secondary Outcome  
Outcome  TimePoints 
To improve quality of life & bring awareness in the patients suffering from Generalised anxiety disorder  there will be improvement in anxiety in 4 weeks after prescribing suitable homoeopathic medicine 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   15/06/2024 
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="0"
Months="9"
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  

NEED FOR THE STUDY:

   Mental Health refers to a broad array of activities directly or indirectly related to the mental well-being component included in the WHO’s definition of health: "A state of complete physical, mental and social well- being, and not merely the absence of disease". Mental and neurological disorders are highly prevalent worldwide. The mental and neurological disorders are responsible for about one percent of deaths; they account for almost 11 per cent of disease burden the world over. The extension of life expectancy and the ageing of the general populations in both developed and developing countries are likely to increase the prevalence of many chronic and progressive physical and mental conditions including neurological disorders. The proportionate share of the total global burden of disease due to neuropsychiatric disorders is projected to rise to 14.7% by 2020.Neuroses, Psychoses, Personality disorders and Psycho-somatic disorders have now been established as the most common causes of illness, leading to personal unhappiness and socially unacceptable behaviour.[1]

     In India the current weighted prevalence of GAD is 2.57%. Risk factors identified were female gender, 40–59 age group, and urban metro dwellers. Around 60% suffered from the disability of varying severity.[8]

Anxiety disorders are among the most prevalent mental disorders in the general population. They are possibly the most common and frequently occurring mental disorders. Unlike the relatively mild, brief anxiety caused by a stressful event (such as speaking in public or a first date), anxiety disorders last at least 6 months and can get worse if they are not treated. Anxiety disorders commonly occur along with other mental or physical illnesses, including alcohol or substance abuse, which may mask anxiety symptoms or make them worse. Predisposing factors leading to anxiety disorders are a combination of genetic and experiential factors. Abnormal genes predispose to pathological anxiety states; however traumatic life events and stress are also etiologically important. Anxiety disorders are with significant morbidity and often are chronic and resistant to treatment.

    Homeopathy as a science is Holistic in its approach. In Chronic affliction such as anxiety disorders, plaguing mankind since centuries, Homoeopathy has to offer something Associated definite and concrete because only Homoeopathy has particular specified methods to combat the diseased condition of chronic nature without any side effects and procure results that are long lasting. Homeopathic constitutional treatment helps eliminate Anxiety disorders, phobias, prevent relapses as well as rebuild self-esteem and self-confidence.

 RESEARCH QUESTION:

 

Whether patients of generalised anxiety disorder along with understanding of miasmatic expression will get beneficial results after prescribing suitable Homoeopathic Medicines?

●     HYPOTHESIS:

      

●     Null Hypothesis:

There will be no significant improvement in cases of generalised anxiety disorder with its miasmatic expression after prescribing suitable homoeopathic medicines.

●     Alternate Hypothesis:

There will be improvement in cases of generalised anxiety disorder with its miasmatic expression after prescribing suitable homoeopathic medicine.

     ANXIETY

The word anxiety is derived from the Latin "ANXIETAS" (to choke, throttle, trouble, and upset) and encompasses behavioural and cognitive responses to the perception of danger. Anxiety is a normal human emotion. In moderation, anxiety stimulates an anticipatory and adaptive response to challenging or stressful events. In excess, anxiety destabilizes the individual and dysfunctional state results.

Anxiety is considered excessive or pathological when it arises in the absence of challenge or stress, when it is out of proportion to the challenge or stress in duration or severity, when it results in significant distress, and when it results in psychological, social, occupational, biological, and other impairment.[2]

     DEFINITION

It is characterized most commonly as a diffuse, unpleasant, vague sense of apprehension, often accompanied by autonomic symptoms such as headache, perspiration, palpitations, tightness in the chest, mild stomach discomfort, and restlessness, indicated by an inability to sit or stand still for long.[3]

     EPIDEMIOLOGY

The anxiety disorders make up one of the most common groups of psychiatric disorders.

The National Comorbidity Study reported that one of four persons met the diagnostic criteria for at least one anxiety disorder. Women (30.5 percent lifetime prevalence) are more likely to have an anxiety disorder than are men (19.2 percent lifetime prevalence). The prevalence of anxiety disorders decreases with higher socioeconomic status.

     HOMOEOPATHIC ORGANON VIEW

Dr. Hahnemann considers mental disease as one-sided disease of the chronic type affecting the whole psychosomatic entity where the brunt of derangement has been shifted on the mental aspect of the human organism after the physical disturbances have been suppressed by unhomoeopathic treatment or through some other causes. (Sec 215- 216). The mind and body are not two absolutely separate entities but they form an individual whole, inseparable in face but distinguishable by mind for easy understanding. As drug proving show that the actions of a drug manifest themselves more or concomitantly through body and mind so that in every fully proved drug- picture there are corporeal symptoms along with alterations of thoughts, feelings, affections. So in natural diseases the physical disturbances are often found associated with their mental counterparts. In the treatment of so called mental diseases we should always be careful to take past history and should try to elicit the physical symptoms which preceded the present condition (may be long ago) and try to get the full picture of disease comprising physical and mental symptoms on the totality of which a similimum remedy is selected.

According to Homoeopathic Science, diseases are caused due to various morbific agents which deranges dynamic vital force of the human being but this morbific noxious agents, do not possess the power of deranging the health of man unconditionally but is made ill only when the person is sufficiently disposed to and susceptible to the attack of morbific cause(aphorism 31) With alternative system of medicine treatment adopted can cause various side effects and surgical treatment which increases the risk of blood clots and infections as age advances.

 

Aphorism 225

There are, however, as has just been stated, certainly a few emotional diseases which have not merely been developed into that form 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 diseases in time destroys the corporeal health, often to a great degree.

Homoeopathic system of medicine with its holistic approach offers relief ANXIETY improving vitality and without any adverse effects. Dr. Hahnemann used the word miasms which means disease causing factors. A miasm in Homoeopathic terms is an invisible polluting substance which once gains entrance overpowers the Vital Force and pollutes the whole system. Miasm creates weakness or tendency to particular disease. Homoeopathy, the unique art and science of medicine, a boon to mankind treats the sick on the principle of Law of Similars. According to the book Organon of Medicine (5th Edition) given by Dr. Samuel Hahnemann , aphorism 11 states that the spiritual self-acting vital force ,present everywhere in the organism, is primarily deranged by morbific agent of a stronger character and this abnormally deranged vital force manifests itself with abnormal sensations and functions which we call as disease as the deranged vital force is perceptible to the patient and physician with abnormal sensations and functions on those parts of organism susceptible to each individual. And hence the Homoeopathic System of Medicine demands each case to be treated based on the concept of Individualization. Thus in treatment of Chronic diseases as well as GENERALISED ANXIETY DISORDER each Individual is assessed for his physical constitution, his moral and intellect, his occupation, mode of living, his habits, his social and domestic relationships, his age and sexual functions etc. as stated by Dr. Samuel Hahnemann in aphorism 5. Each of the chronic miasm psora, sycosis and syphilis has its own peculiar type or character and it alone or in combination with another leads to signs and symptoms of the disease. Further it becomes essential to treat chronic miasmatic disease because as given in aphorism 78 Fifth Edition of Organon of Medicine that if left untreated even the best mental and corporeal regimen can torment the patient towards end of his life with ever increasing sufferings. In cases of ANXIETY DISORDERS Homoeopathic Remedies in the first place are employed to make a quality of patient’s life arresting the progression of disease and improving vitality.

Homoeopathy thus considers ANXIETY as chronic manifestations of deep-seated miasmatic disorders. If not treated properly with suitable Homoeopathic medicines it will persist throughout the patient’s life and can also be transmitted to next generations. Dr. Hahnemann has recognized three forms of miasms in his book “The Chronic Diseases Their Peculiar Nature and Their Homoeopathic Cure”.

     MIASMATIC MANIFESTATION[12]:

PSORA: Psoric patients are anxious to the point of worry and fear.Anxiety on awakening in the morning which may at times compel them to move about.

SYCOSIS: Anxiety from changes in the weather and from humidity typifies the sycotic patient.

SYPHILIS: In syphilis, anxiety occurs at night.

 

 

 
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