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CTRI Number  CTRI/2025/03/082801 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Homeopathy for Mental Illness 
Scientific Title of Study   Approach to the mental illness especially hysterical cases in clinical medicine And therapeutic utility of the homoeopathic remedies  
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dharmesh Savaj 
Designation  Pg scholar 
Affiliation  Rajkot homoeopathic medical college 
Address  Depatment of practice of medicine Rajkot homoeopathic medical college Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat

Surat
GUJARAT
394107
India 
Phone  9879836979  
Fax    
Email  dsavaj39@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hitarth Mehta 
Designation  Principal and HOD Departmetn of practice of medicine 
Affiliation  Rajkot homoeopathic medical college 
Address  Depatment of practice of medicine Rajkot homoeopathic medical college Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat

Rajkot
GUJARAT
360002
India 
Phone  9825340073  
Fax    
Email  hitarth.mehtarhmc@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Dharmesh Savaj 
Designation  Pg scholar 
Affiliation  Rajkot homoeopathic medical college 
Address  Depatment of practice of medicine Rajkot homoeopathic medical college Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat

Surat
GUJARAT
394107
India 
Phone  9879836979  
Fax    
Email  dsavaj39@gmail.com  
 
Source of Monetary or Material Support  
Depatment of practice of medicine Rajkot homoeopathic medical college Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat  
 
Primary Sponsor  
Name  Rajkot homoeopathic medical college 
Address  Depatment of practice of medicine Rajkot homoeopathic medical college Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat  
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 Dharmesh Savaj  Sainath homoeopathic hospital under Rajkot homoeopathic medical college  Rajkot homoeopathic medical college Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat pin 360002
Rajkot
GUJARAT 
9879836979

dsavaj39@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: F447||Conversion disorder with mixed symptom presentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INDIVIDUALIZED HOMOEOPATHIC MEDICINE  Individualized homoeopathic medicine. Mode of Administration: Oral (sublingual) Selection of potency, dose and repetition : individualised medicine will be presecribed in 30, 200, 1 M potency. selection of dosage, potency and repitition will be according to susceptibility of patient and principles of organon of medicine 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 20-60 years.
Both genders (Male and Female) will be considered.
DSM-5 SCORE
ICD-11 SCORE
 
 
ExclusionCriteria 
Details  Patients with other systemic illness or serious pathological conditions.
Patients above 60 years and below 20 years of age.
Patients taking other therapeutic measures for adverse events (AE) or any other diseases
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Approach To The Mental Illness Especially Hysterical Cases In Clinical Medicine And Therapeutic Utility Of The Homoeopathic Remedies  The follow-up of cases will be done up to 4 - 6 follow – ups every 15 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical Symptom Relief
Etiological Insights
Comparison with Conventional Treatments 
The follow-up of cases will be conducted up to four to six follow-ups, scheduled every fifteen days. 
 
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 3/ Phase 4 
Date of First Enrollment (India)   16/07/2025 
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 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  

Definition: "Functional Neurological Symptom Disorder (FNSD) is a condition characterized by neurological symptoms that are inconsistent with or cannot be fully explained by neurological or medical conditions. These symptoms are real and distressing but arise from psychological factors rather than direct physiological damage."

  • Diagnostic Criteria: Briefly outline the diagnostic criteria for FNSD as specified in major classification systems like
  • DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) or

ICD-11 (International Classification of Diseases, 11th Edition):

OBJECTIVE OF THE STUDY

AIM

Approach To The Mental Illness Especially Hysterical Cases In Clinical Medicine And Therapeutic Utility Of The Homoeopathic Remedies

OBJECTIVE

Primary Objective.

Approach To The Mental Illness Especially Hysterical Cases In Clinical Medicine And Therapeutic Utility Of The Homoeopathic Remedies

Secondary Objective

1)      advance approach to treat the different patterns of case of hysterical disorder (also called functional neurological symtoms disorder) by using different homoeopathic remedies

2)      Confirm the Diagnostic Criteria by use of DSM-5 and ICD-11 scale for diagnosing  FNSD .

METHOD OF COLLECTION OF DATA

o   Type of Study – Experimental, Prospective.

o   Sample Size – 40 cases

o   Selection of Cases –Randomly select cases based on the criteria set by "Sainath Homoeopathic Hospital" affiliated with Rajkot Homoeopathic Medical College.

o   Statistical Methods – In the forthcoming analysis, we will employ a comprehensive approach to scrutinize the data, utilizing a range of statistical tools such as frequency tables, percentages, diagrams, and graphs. This extensive examination will not only involve the presentation of descriptive statistics but will also encompass the illustration of results through various visual representations.This multifaceted analysis aims to provide a thorough understanding of the dataset, offering valuable insights into the effectiveness of the treatment under consideration.

CRITERIA FOR WITHDRAWAL AND DROP-OUT

Withdrawal Criteria

o   Withdrawal is also considered if the disease worsens or advances despite treatment.

Drop-Out Criteria:

o   Cases with no follow-ups are considered for drop-out.

o   Cases with inadequate follow-ups (less than 3 irregular follow-ups) are also eligible for drop-out.

INTERVENTION GUIDELINES:

o   Individualized Homoeopathic Medicine selection is based on the Totality of Symptoms for each case as their similimum.

o   Potency, dose, and repetition are determined by the patient’s susceptibility.

EXPECTED OUTCOME

In a prospective evaluation of homoeopathic intervention for hysterical disorder the expected outcomes can be assessed through a DSM-5 CRITERIA AND ICD -11 CRITERIA analysis. The study aims to investigate both the etiology of hysterical disorder and the treatment outcomes following homoeopathic interventions. Here are potential expected outcomes:

1.      DSM-5 CRITERIA :

A rating of 5 would indicate that the symptoms are clearly inconsistent with known neurological or medical conditions, suggesting the possibility of FNSD.

 

A rating of 5 implies strong evidence that the symptoms are not compatible with recognized medical conditions, supporting the diagnosis of FNSD.

 

A rating of 5 would mean that the symptoms cannot be more appropriately explained by another disorder, which is crucial for diagnosing FNSD.

 

A rating of 5 indicates that the symptoms are genuinely experienced and not intentionally produced, which is essential for diagnosing FNSD

 

A rating of 5 would indicate that the symptoms are causing significant and severe impairment, aligning with the DSM-5 requirement for FNSD diagnosis.

 

2.      ICD-11 CRITERIA :

A rating of 5 indicates that the symptoms are clearly altered motor or sensory functions that do not align with known medical or neurological conditions, suggesting the presence of FNSD.

 

A rating of 5 implies strong evidence from clinical examination and diagnostic testing that the symptoms do not align with recognized medical conditions, supporting FNSD.

 

A rating of 5 means that after ruling out other possible conditions, the symptoms cannot be better accounted for by another disorder, reinforcing the diagnosis of FNSD.

 

A rating of 5 would indicate that the symptoms have a profound impact on the patient’s ability to function in various aspects of life, which is essential for the diagnosis of FNSD.

A rating of 5 indicates that the symptoms are genuinely experienced and not deliberately fabricated, which is crucial for diagnosing FNSD.

3.      Clinical Symptom Relief:

      Improvement in overall well-being and quality of life for individuals undergoing   homoeopathic treatment.

4.      Etiological Insights:

Identification and understanding of potential etiological factors contributing to hysterical disorder (FNSD). The study may provide insights into the underlying causes of the condition, facilitating a more targeted and personalized approach to treatment.

5.      Patient Satisfaction and Adherence:

Assessment of patient satisfaction with homoeopathic intervention and evaluation of treatment adherence. Positive patient experiences and adherence are essential for the long-term success of any therapeutic approach.

6.      Comparison with Conventional Treatments:

Comparative analysis of the outcomes of homoeopathic intervention with conventional treatments for hysterical disorder (FNSD). This may include assessing the efficacy, safety, and tolerability of homoeopathic remedies in comparison to standard medical interventions.

It’s important to note that the actual outcomes may vary, and the study should be conducted with rigorous methodology and statistical analysis to ensure the reliability and validity of the results.

Hypothesis:

v  Null Hypothesis (H0):

o   There is no significant difference in the treatment outcomes for hysterical disorder (FNSD) individuals receiving homoeopathic intervention

v  Alternative Hypothesis (H1):

There is a significant difference in the treatment outcomes for hysterical disorder (FNSD) individuals receiving homoeopathic intervention.

BACKGROUND AND PURPOSE

Introduction:

Hysteria is a historical term once used to describe a range of psychological and physical symptoms, often linked to emotional distress or trauma. It was traditionally associated with women and characterized by symptoms like uncontrolled emotions, convulsions, or fainting. The ultimate understanding of hysteria has evolved, and it is now seen as a precursor to more modern diagnoses like conversion disorder or somatic symptom disorder..While conventional medical treatments are widely employed, there is a growing interest in alternative approaches, such as homeopathic intervention. This study aims to prospectively evaluate the efficacy of homeopathic treatments in managing Hysteria in clinical medicine with use of DSM-5 CRITERIA .

Ø  Rising Incidence of Hysterical Disorders.

Today, the focus is on understanding these symptoms through a psychological and neurological lens rather than through the outdated concept of hysteria. Studying past cases highlights the progress from viewing mental health through a purely physiological lens to a more integrated view that considers psychological, neurological, and social factors.

Cultural Impact: The way hysteria was perceived and treated varied across cultures and historical periods. Understanding these variations helps us appreciate the role of cultural context in shaping medical practice and emphasizes the need for culturally sensitive approaches in contemporary care.

Avoiding Past Mistakes: By studying the history of hysteria ,helps prevent misdiagnosis and ensures that current practices are based on scientific evidence rather than outdated beliefs

Treatment Evolution: Historical treatments for hysteria helps us appreciate the advancements in therapeutic approaches and reinforces the importance of evidence-based,human treatments in modern medicine.

Ø  Current Limitations in Conventional Treatments:

Despite advancements in conventional medical treatments, some patients may experience drug dependence, adverse effects, or inadequate responses to quality life care. The study aims to identify whether homeopathic intervention can offer a viable approach to address the limitations of conventional treatments.

Ø  Holistic Approach to Patient Care:

Homeopathy is known for its holistic approach to patient care, considering individual symptoms, lifestyle, and emotional well-being. Examining the holistic aspects of homeopathic treatments may contribute to a more comprehensive understanding of managing cases of hysterical disorder.

Ø  Patient-Centric Outcomes:

The study seeks to evaluate not only the physiological changes but also patient-reported outcomes, considering factors such as quality of life, energy levels, and emotional well-being. Understanding these patient-centric outcomes will contribute to a more comprehensive assessment of the overall effectiveness of homeopathic interventions.

In conclusion, there is a compelling need for this study to address the rising incidence of hysterical disorders , explore alternative treatments, overcome limitations in current approaches, and provide a more holistic perspective on patient care. The use of established scales and analytical tools will ensure a rigorous evaluation of the efficacy of homeopathic interventions in managing hysterical disorder.

 
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