跳至主要内容
临床试验/CTRI/2025/03/082801
CTRI/2025/03/082801尚未招募Phase 3 4

Approach to the mental illness especially hysterical cases in clinical medicine And therapeutic utility of the homoeopathic remedies

Rajkot homoeopathic medical college1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月16日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Approach To The Mental Illness Especially Hysterical Cases In Clinical Medicine And Therapeutic Utility Of The Homoeopathic Remedies

研究概览

简要总结

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

OBJECTIVEPrimary 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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 20-60 years.
  • Both genders (Male and Female) will be considered.
  • DSM-5 SCORE ICD-11 SCORE.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: The follow-up of cases will be done up to 4 - 6 follow – ups every 15 days.

次要结局

  • Clinical Symptom Relief(Etiological Insights)

研究者

发起方
Rajkot homoeopathic medical college
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Dharmesh Savaj

Rajkot homoeopathic medical college

研究点 (1)

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