FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071732 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Effectiveness of Homoeopathic medicines in the treatment of Generalised Anxiety Disorder 
Scientific Title of Study   To Assess the Effectiveness of Indiidualised Homoeopathic Medicine in Cases Of Generalised Anxiety Disorder By Using GAD-7 Scale. 
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 Nidhi Rathod 
Designation  PG Scholer 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College 
Address  Jawaharlal Nehru Homoeopathic College,Department of Practice of Medicine,Post Graduation Division,Parul University,P.O.Limda,Ta.Waghodia, Dist.Vadodara, Gujarat 391760.

Vadodara
GUJARAT
391760
India 
Phone  9898630712  
Fax    
Email  drnidhiar20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Samir Gupta 
Designation  ASSISTANT PROFESSOR,PRACTICE OF MEDICINE. 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College 
Address  Jawaharlal Nehru Homoeopathic Medical College,Department of Practice of Medicine, Post Graduatio Division, Parul University,P.O.Limda, Ta.Waghodia, Dist. Vadodara, Gujarat 391760.


GUJARAT
391760
India 
Phone  7709396584  
Fax    
Email  Samir.gupta87142@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Rathod 
Designation  PG Scholer 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College  
Address  Jawaharlal Nehru Homoeopathic College,Department of Practice of Medicine,Post Graduation Division,Parul University,P.O.Limda,Ta.Waghodia, Dist.Vadodara, Gujarat 391760.

Vadodara
GUJARAT
391760
India 
Phone  9898630712  
Fax    
Email  drnidhiar20@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Homoeopathic Medical College and Hospital. 
 
Primary Sponsor  
Name  Jawaharlal Nehru Homoeopathic Medical College And Hospital 
Address  Jawaharlal Nehru Homoeopathic Medical College,Department of Practice of Medicine,Post Graduation Division,Parul University,P.O.Limda,Ta.Waghodia, Dist.Vadodara Gujarat 391760 
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 Nidhi Rathod  Jawaharlal Nehru Homoeopathic Medical College and Hospital  Room number 110, Medicine OPD, Jawaharlal Nehru Homoeopathic Medical College and hospital, Parul University, P.O.Limda, Ta.Waghodia, Dist.Vadodara 391760 Gujarat
Vadodara
GUJARAT 		 9898630712

drnidhiar20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Homoeopathic Medical College And Hospital Institutional Ethics Committee For Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individulised Homoeopathic Medicine  Individualised Homoeopathic Medicine. Duration of Therapy-3 months.Mode Of administration Oral (Sublingual), Selection of Potency,dose and repetition:Individulised medicine will be prescribed in 30,200 and 1M potencies. selection of potency, dosage and Repetition will be done according to the susceptibility of patient and priciples of Organon of Medicine. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Cases diagnosed with DSM-5 TR criteria of Generalized Anxiety Disorders
2.Patients between 18 to 60 years of age.
3.Newly diagnosed and Pre-diagnosed cases.
4.Both gender and all socioeconomic class
5.Patients who will give written consent to participate in the study

 
 
ExclusionCriteria 
Details  1.Patients who scores 15-21 severe anxiety in GAD-
7 scale
2.Patient suffering from other anxiety disorders –
social anxiety disorder, obsessive-compulsive
disorder, suicidal tendency, post traumatic
stress disorder
3.Having disturbance due to substance abuse and
Other Psychiatric emergency
4.Pregnant and lactating women.
5.cases with irregular follow ups, patients who develops panic attacks.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the severity & outcome of patients before & after treatment by using GAD-7 assessment scale for generalized anxiety disorder.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To prepare the list of frequently indicated Homoeopathic medicine for Generalized Anxiety Disorder.  3 Months 
 
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)   12/08/2024 
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="1"
Months="0"
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  

Generalized anxiety disorder involves persistent and excessive worry that interferes with daily activities and may be accompanied by physical symptoms, such as restlessness, easily fatigued or feeling on edge, difficulty concentrating, muscle tension, irritability and sleep disturbance. It is characterised by Excessive, Persistent, and uncontrollable worry about everyday things such as work, health, future, finance, family and relationships. 

 

Homoeopathy treats generalized anxiety disorder (GAD) by addressing individual symptoms and overall well-being through Individualised remedies. Homoeopathy aims to reduce anxiety’s frequency and intensity, improve quality of life, and support emotional and psychological health. 

 

Case taking will be done according to the schema of Dr. Hahnemann, after which the diagnosis will be confirmed using DSM-5 criteria and the severity of generalized anxiety disorder will be assessed using the GAD-7 Scale before and after treatment. Individualised Homoeopathic medicine will be prescribed after thorough case analysis and evaluation, with regular follow up every 14 days or as needed to evaluate patient progress, assess treatment response, and achieve maximum therapeutic benefits.

 

A non-randomised study will be conducted to assess the effect of Individualised Homoeopathic medicine in cases of Generalised Anxiety Disorder. Study will investigate the potential benefits of Homoeopathy in managing Generalised Anxiety Disorder. The study will enroll 40 patients and will be conducted at Jawaharlal Homoeopathic Medical College and Hospital, Parul University, Vadodara, 391760 Gujarat-India. 

 

 
Close