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临床试验/CTRI/2025/10/096052
CTRI/2025/10/096052尚未招募不适用

TO STUDY THE UTILITY OF RUBRICS FROM SYNTHESIS REPERTORY VERSION 9.1 BY Dr.FREDERICK SCHROYENS IN THE MANAGEMENT OF GENERAIZED ANXIETY DISORDER IN THE AGE GROUP OF 18 - 35 YEARS - AN EXPERIMENTAL NON CONTROLLED STUDY

DR SURBHI OHAL1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年10月30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
34
试验地点
1
主要终点
Outcome assessment will be done based on the improvement of signs and symptoms of Generalized Anxiety Disorder at end of treatment and pre and post score of Hamilton Anxiety Rating Scale

研究概览

简要总结

INTRODUCTION

The prevalence of Generalized Anxiety Disorder is increasing. It is more common in young adult population. Generalized Anxiety Disorder is excessive anxiety and worry about multiple events or activities for more days than not atleast for six months. In conventional medicine Generalized Anxiety Disorder is treated with Benzodiazipines, Venlafaxine, Selective Serotonin Reuptake Inhibitors. Generalized Anxiety Disorder is the manifestation of the symptoms of anxious mind. The disease is the outwardly reflected picture of internally dearranged vital force. In Homoeopathy not only the disease part is considered the man in disease is considered as whole, the mental generals and the physical general symptoms are also considered to form the picture of the disease. The Homoeopathic Repertory consists of symptoms in the form of rubrics. The medicines are given corresponding for each rubric. There are rubrics for anxiety with medicines which can be used for treating Generalized Anxiety Disorder. The Synthesis Repertory Version 9.1 by Dr. Frederick Schroyens is based on the philosophy of Deductive logic. It includes many general, particular, diagnostic, clinical rubrics. This Repertory includes many rubrics related to anxiety, so it can be used during repertorization for medicine in treating Generalized Anxiety Disorder

AIMS AND OBJECTIVES

1.To Study the Utility of Rubrics from the Synthesis Repertory version 9.1 by Dr. Frederick Schroyens in the management of Generalized Anxiety disorder in the age group of 18 to 35years.

2.To study pre and post scores of Hamilton Anxiety Rating Scale for Generalized Anxiety Disorder.

3.To study Clinical presentation of Generalized Anxiety Disorder.

4.To study the utility of Homoeopathic medicines in the management of Generalized Anxiety Disorder.

MATERIALS AND METHODOLOGY

  1. TYPE OF STUDY DESIGNAn Experimental Non-Controlled Study

2)SETTING  Clinically diagnosed cases of Generalized anxiety disorder will be collected from the OPD of the Institute.

  1. DURATION OF STUDY: 18 months.

  2. METHODS OF SELECTION OF STUDY SUBJECTS: 4.1. Inclusion Criteria: a. Patients of age group 18yrs – 35yrs

b. Patients of all Gender.

c. Clinically diagnosed patients of Generalized Anxiety Disorder.

d. Mild and Mild to Moderate Severity of Generalized Anxiety Disorder which scores 0 to 24 on Hamilton Anxiety Rating Scale.

Exclusion Criteria

a. Patients with Comorbidity of depression and Agoraphobia b. Patients with other Psychiatric disorders. c. Patients with Uncontrollled Systemic comorbidity. d. Suspected Immunocompromised individuals. e. Pregnant and lactating Female. f. Patient on medication for psychiatric complaints or Herbal medicines.

Subject withdrawal criteria: a. Patients who do not wish to continue the treatment. b. Patients who do not follow up regularly. c. Patient requiring any Emergency Medical treatment.

  1. METHOD OF SELECTION OF COMPARISON OR CONTROL GROUP: Not Applicable

  2. MATCHING CRITERIA: Not Applicable

  3. SPECIFICATION OF INSTRUMENTS AND RELATED MEASUREMENTS • Homoeopathic Case Taking Proforma • OUTCOME ASSESSMENT TOOL: Table 1: Prevalidated Scale - Hamilton Anxiety Rating Scale

The outcome is assessed in terms of

1.      Improved

2.       Not Improved

Which is done of following basis

1.The pre and post Hamilton Anxiety Rating Scale score before and after Homoeopathic treatment will be considered.

2.The patient will be considered as improved only after satisfying both the above criteria that is Clinical Signs and Symptoms and Hamilton Anxiety Rating Score.

  1. SAMPLE SIZE: 34 subjects will be selected.

  2. SAMPLING TECHNIQUE: Non-Probability Purposive Sampling.

  3. Methods of data collection relevant to objectives

  1. Non Probability Purposive sampling will be done.

  2. Homoeopathic Case Taking Proforma.

  3. Cases will be recorded from the Institutes OPD.

  4. Each case will be studied at the interval of 15 days till date of improvement whichever is earlier.

  4) Study Instrument or Data Collection Tools

  1. Homoeopathic case taking format to form a totality.

  2. Rubrics from Synthesis Repertory version 9.1 to from repertorial totality.

  3. Anxiety assessment tool – Hamilton Anxiety Rating Scale.

  4. Appropriate reference books like Psychiatric books, Medicine books, Homoeopathic Materia Medica, Repertory Textbooks, different Homoeopathic journals and research papers will be considered.

5.RADAR Software will be used for repertorization through Synthesis Repertory version 9.1

  1. Data management and analysis Procedure:
  1. Duration of study – 18 months.

  2. Duration of each case – Each case will be studied upto 8 months.

  3. Duration of follow up of each case is 15 days or earlier if required.

4.Clinical outcome assessment will be done at base line of 1,4 and 8 months.

  1. Plan for Statistical analysis Statistical analysis

Data collected will be compiled on to a MS Office excel worksheet and will be subjected to statistical analysis using an appropriate package like SPSS software. Descriptive statistics like frequency and percentage of categorical data, mean and Standard deviation of numerical data in each time interval will be depicted. Normality of numerical data will be checked using Shapiro  Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data statistical tests will be determined.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)

入选标准

  • Patients of age group 18yrs – 35yrs.
  • Patients of all Gender.
  • Clinically diagnosed patients of Generalized Anxiety Disorder.
  • Mild and Mild to Moderate Severity of Generalized Anxiety Disorder which scores 0 to 24 on Hamilton Anxiety Rating Scale.

排除标准

  • Patients with Comorbidity of depression and Agoraphobia Patients with other Psychiatric disorders.
  • Patients with Uncontrollled Systemic comorbidity.
  • Suspected Immunocompromised individuals.
  • Pregnant and lactating Female.
  • Patient on medication for psychiatric complaints or Herbal medicines.

结局指标

主要结局

Outcome assessment will be done based on the improvement of signs and symptoms of Generalized Anxiety Disorder at end of treatment and pre and post score of Hamilton Anxiety Rating Scale

时间窗: Duration of study 18 months. | Duration of each case is each case will be studied upto 8 months. | Duration of follow up of each case 15 days or earlier if required. | Clinical outcome assessment will be done at base line of 1 month 4 month and 8 months.

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
DR SURBHI OHAL
申办方类型
Other [OTHER (SELF SPONSORED)]
责任方
Principal Investigator
主要研究者

DR SURBHI OHAL

DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPIATL AND PG INSTITUTE

研究点 (1)

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