| CTRI Number |
CTRI/2026/02/104137 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
To study the effectiveness of Homoeopathic treatment in Generalized anxiety disorder and quality of life |
|
Scientific Title of Study
|
Assessment of effectiveness of individualized Homoeopathic medicine on Generalized anxiety disorder and quality of life -A quasi experimental 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 Pragati Ningappa Muddikol |
| Designation |
PG scholar |
| Affiliation |
Dr B D Jatti Homoeopathic medical college hospital and P G research centre Dharwad Karnataka |
| Address |
Dept of Homoeopathic Materia Medica
Medicine Division OPD No 1
Dr B D Jatti Homoeopathic medical college hospital and P G research centre Dharwad Karnataka
Dharwad
KARNATAKA
580001
India |
| Phone |
6361079303 |
| Fax |
|
| Email |
pragatinm99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar C Gaddi |
| Designation |
Professor and HOD |
| Affiliation |
Dr B D Jatti Homoeopathic medical college hospital and P G research center Dharwad Karnataka |
| Address |
Dept of Homoeopathic Materia Medica
Medicine Division OPD No 1
Dr B D Jatti Homoeopathic medical college hospital and P G research centre Dharwad Karnataka
Dharwad
KARNATAKA
580001
India |
| Phone |
9880252994 |
| Fax |
|
| Email |
kcgaddi76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragati Ningappa Muddikol |
| Designation |
PG scholar |
| Affiliation |
Dr B D Jatti Homoeopathic medical college hospital and P G research centre Dharwad Karnataka |
| Address |
Dept of Homoeopathic Materia Medica
Medicine Division - OPD No 1
Dr B D Jatti Homoeopathic medical college hospital and P G research centre Dharwad Karnataka
Dharwad
KARNATAKA
580001
India |
| Phone |
6361079303 |
| Fax |
|
| Email |
pragatinm99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr PRAGATI NINGAPPA MUDDIKOL Dr B D JATTI HOMOEOPATHIC MEDICAL COLLEGE
HOSPITAL AND P G RESEARCH CENTER
DHARWAD 580001
|
|
|
Primary Sponsor
|
| Name |
Dr Pragati Ningappa Muddikol |
| Address |
Dr B D Jatti Homoeopathic medical college hospital and P G research centre Dharwad Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pragati Ningappa Muddikol |
Dr B D Jatti Homoeopathic Hospital Dharwad |
Dept of Homoeopathic Materia Medica
Medicine Division OPD No 1
Dr B D Jatti Homoeopathic medical college hospital and P G research centre Dharwad Karnataka
Dharwad
KARNATAKA |
63610 79303
pragatinm99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr B D JATTI HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL P G RESEARCH CENTER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
All subjects will be followed up every two weeks and as per the need of each case for a period of 24 weeks
Dose and Potency will be administered orally as per the susceptibility of each case |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who have given consent for the study
2. Subjects satisfying the DSM 5 Diagnostic Criteria for Generalized Anxiety Disorder
3. All adults in the age group 20 to 60 irrespective of socioeconomic status gender and ethnic group
4. Subjects with mild and moderate anxiety according to the Hamilton Anxiety Rating Scale
|
|
| ExclusionCriteria |
| Details |
1. Subjects with severe anxiety and no anxiety according Hamilton Anxiety Rating Scale
2. Subjects who are suffering from panic disorder phobias OCD PTSD and major depressive disorder
3. Subjects who are suffering from other systemic diseases and are receiving any medical treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in score of the Hamilton Anxiety Rating Scale and WHOQOL BREF at the end of 6 months of follow up |
Reduction in the clinical score of HAM A and WHOQOL BREF at the end of 6 month of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the clinical symptoms of generalised anxiety disorder and improvement in quality of life |
All subjects will be followed up every 15 days and as per the need of each case for a period of 6 months |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
28/02/2026 |
| 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
|
“Generalized anxiety disorder (GAD) is defined as excessive anxiety and worry about several events or activities for most days during at least a 6-month period. The worry is difficult to control and is associated with somatic symptoms, such as muscle tension, irritability, difficulty in sleeping, and restlessness”. GAD is one of the important subtypes of anxiety disorders affecting a person’s ability to live well, work well and have a productive life.
The specific cause of GAD is idiopathic. Probable causes may be of biological (Neurochemical imbalance, familial heredity), psychological (low self-esteem, poor coping abilities) or of social (Chronic stress, poverty, trauma, lack of support and urban living)origins. GAD affects not only the psychological sphere but also the somatic component of the person’s life. The overall quality of life is significantly affected by reduced work quality and a lack of enjoyment in life. Homoeopathy, with its holistic and individualized approach, focuses on treating the person as a whole by addressing their susceptibility to illness. It offers a potential avenue for safe, gentle, and long-lasting relief. Homoeopathic remedies are prescribed considering the person as a whole and not their individual parts. Thus, showing immense scope in its treatment, which is an understudied area. So, here is a sincere effort to assess the effectiveness of individualized Homoeopathic medicines in the treatment of GAD.
RESEARCH HYPOTHESIS: Individualized Homoeopathic medicines may be effective in the treatment of Generalized Anxiety Disorder. NULL HYPOTHESIS: Individualized Homoeopathic medicines may not be effective in the treatment of Generalized Anxiety Disorder. |