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CTRI Number  CTRI/2025/10/096052 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy
Other (Specify) [Clinically diagnosed patients of Generalized Anxiety Disorder]  
Study Design  Other 
Public Title of Study   TO STUDY THE UTILITY OF RUBRICS FROM SYNTHESIS REPERTORY VERSION 9.1 IN THE MANAGEMENT OF GENERALIZED ANXIETY DISORDER IN THE AGE GROUP OF 18 – 35 YEARS 
Scientific Title of Study   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  
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 SURBHI OHAL 
Designation  PG STUDENT 
Affiliation  DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPIATL AND PG INSTITUTE 
Address  OPD NO 2 [MEDICINE]DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG INSTITUTE INSTITUTIONAL AREA SECTOR 4 KHARGHAR NAVI MUMBAI- 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  7304176842  
Fax    
Email  ohalsurbhi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR UTTARA AGALE  
Designation  GUIDE AND ASSOCIATE PROFESSOR 
Affiliation  DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPIATL AND PG INSTITUTE 
Address  DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG INSTITUTE INSTITUTIONAL AREA SECTOR 4 KHARGHAR NAVI MUMBAI- 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9850869404  
Fax    
Email  uttaraagale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR UTTARA AGALE 
Designation  GUIDE AND ASSOCIATE PROFESSOR 
Affiliation  DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPIATL AND PG INSTITUTE 
Address  DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING OPD NO 2 [MEDICINE] DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG INSTITUTE INSTITUTIONAL AREA SECTOR 4 KHARGHAR NAVI MUMBAI- 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9850869404  
Fax    
Email  ohalsurbhi@gmail.com  
 
Source of Monetary or Material Support  
DR GD POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG INSTITUTE KHARGHAR NAVI MUMBAI 
 
Primary Sponsor  
Name  DR SURBHI OHAL 
Address  INSTITUTIONAL AREA SECTOR 4 KHARGHAR NAVI MUMBAI- 410210 
Type of Sponsor  Other [OTHER (SELF SPONSORED)] 
 
Details of Secondary Sponsor  
Name  Address 
DR UTTARA AGALE  DR GD POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG INSTITUTE INSTITUTIONAL AREA SECTOR 4 KHARGHAR NAVI MUMBAI- 410210 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SURBHI OHAL  DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE AND PG INSTITUTE  DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING OPD NO 2 [MEDICINE] GROUND FLOOR DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG INSTITUTE INSTITUTIONAL AREA SECTOR 4 KHARGHAR NAVI MUMBAI 410210
Raigarh
MAHARASHTRA 
7304176842

ohalsurbhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR G D POL FOUNDATION YMT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG INSTITUTE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mild and Mild to Moderate Severity of Generalized Anxiety Disorder which scores 0 to 24 on Hamilton Anxiety Rating Scale in 18 to 35 yrs. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  TO STUDY THE UTILITY OF RUBRICS FROM SYNTHESIS REPERTORY VERSION 9.1 BY Dr FREDERICK SCHROYENS IN THE MANAGEMENT OF GENERALIZED ANXIETY DISORDER IN THE AGE GROUP OF 18 to 35 YEARS to AN EXPERIMENTAL NON CONTROLLED STUDY   The pre and post Hamilton Anxiety Rating Scale score before and after Homoeopathic treatment will be considered.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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
 
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.
 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   30/10/2025 
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="1"
Months="6"
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  

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.

3) DURATION OF STUDY: 18 months.

4) 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.

5) METHOD OF SELECTION OF COMPARISON OR CONTROL GROUP: Not Applicable

6) MATCHING CRITERIA: Not Applicable

8) 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

5) 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.

6) 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.

 
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