| CTRI Number |
CTRI/2026/02/103768 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effect of homoeopathic medicine on Anxiety Disorder |
|
Scientific Title of Study
|
Effect of individualized homoeopathic treatment on generalized anxiety disorder in adults assessed by the generalized anxiety disorder 7 (GAD-7) scale: 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 Pushkar Ramesh Mahajan |
| Designation |
Ph.D. Scholar |
| Affiliation |
DKMM Homoeopathic Medical College and Hospital |
| Address |
Department of materia medica, DKMM Homoeopathic Medical College and Hospital, shri guru ganesh nagar,behind bibi ka maqbara, Chh. Sambhajinagar
Aurangabad
MAHARASHTRA
431004
India |
| Phone |
7588052480 |
| Fax |
|
| Email |
mahajanpushkar11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini R Ankushe |
| Designation |
Professor Homoeopathic Materia Medica |
| Affiliation |
DKMM Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic materia medica,DKMM Homoeopathic Medical College and Hospital, shri guru ganesh nagar,behind bibi ka maqbara, Chh. Sambhajinagar
Aurangabad
MAHARASHTRA
431004
India |
| Phone |
9421867691 |
| Fax |
|
| Email |
shaliniankushe123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushkar Ramesh Mahajan |
| Designation |
Ph. D. Scholar |
| Affiliation |
DKMM Homoeopathic Medical College and Hospital |
| Address |
Department of materia medica, DKMM Homoeopathic Medical College and Hospital, shri guru ganesh nagar,behind bibi ka maqbara, Chh. Sambhajinagar
Aurangabad
MAHARASHTRA
431004
India |
| Phone |
7588052480 |
| Fax |
|
| Email |
mahajanpushkar11@gmail.com |
|
|
Source of Monetary or Material Support
|
| DKMM HMC AND HOSPITAL CHH SAMBHAJINAGAR MAHARASHTRA INDIA PIN 431004 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Pushkar R Mahajan |
DKMM HMC AND HOSPITAL |
OPD no 1, Ground floor, Below Girls Hostel, DKMM HMC and Hospital,Shri guru ganesh nagar, behind bibi ka maqbara, Chh Sambhajinagar PIN 431004
Aurangabad
MAHARASHTRA |
7588052480
mahajanpushkar11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DKMM Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, (2) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Individualized Homoeopathic medicine with appropriate potency selected by detail case taking based on homoeopathic principal and GMP certified company medicine will be given in globules , 4 globules on tongue based on need they may be repeated infrequently or frequently which will be decided by susceptibility assessment. Homoeopathic treatment given for 6 months. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(1) Diagnosed as generalized anxiety disorder as per DSM V diagnostic criteria.
(2) Patients in age group 18 to 60 years at a time of enrollment
(3) Patients of both the sexes taken.
(4) Minimum duration of treatment should be at least 6 months.
(5) Generalized Anxiety Disorder 7 scale score ranging from 5 to 14.
(6) Patients are willing to only Homoeopathic treatment for the GAD.
(7) Able to provide written informed consent and able to understand study procedures and questionnaires in the study language.
(8) No psychotropic medication for at least 4 weeks prior to baseline
|
|
| ExclusionCriteria |
| Details |
(1) Current primary psychiatry diagnosis other than GAD that requires immediate alternative management (Eg. Psychotic disorders, bipolar disorder)
(2) Cases diagnosed with severe major depression disorder with active suicidal ideation or intent (assessed clinically); any participants with imminent suicidal risk should be referred to urgent care and excluded.
(3) Current substance use disorder (moderate–severe) or active dependence on alcohol or illicit drugs in the past 3 months.
(4) Use of new psychotropic medication, psychotherapy, or other formal anxiety treatment initiated within 4 weeks prior to baseline
(5) Patient having uncontrolled Thyroid disease or severe cardiac diseases, diagnosed case of cancer.
(6) Pregnant or breastfeeding women during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To measure the pre- and post- changes in anxiety levels and intensity such as nervousness on edge, being able to control worry, worrying about different things, trouble relaxing, restlessness, irritability, anticipation assessed by Generalized Anxiety Disorder 7 (GAD 7) scale which will be assessed before and after six months of the Homoeopathic treatment among the adults suffering from Generalized Anxiety Disorders. |
1. To measure the pre- and post- changes in anxiety levels and intensity, assessed by Generalized Anxiety Disorder 7 (GAD 7) scale will be assessed before and six months after the Homoeopathic treatment among the adults suffering from Generalized Anxiety Disorders. GAD 7scale is applied two times firstly before homoeopathic intervention and secondly after six months of homoeopathic treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the therapeutic indications of the commonly prescribed and clinically relevant individualized homoeopathic medicines effective for the treatment of GAD among adults.
2. To describe the distinguishing Materia Medica features that aid in differentiating among the most frequently indicated homoeopathic medicines prescribed for GAD.
|
6 months to 12 months |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
25/02/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim- To evaluate change in anxiety levels among the adults diagnosed with generalized anxiety disorder following individualized homoeopathic treatment , as measured using GAD 7 scale . To explore the therapeutic indication and differential materia medica features of commonly prescribed homoeopathic medicines in the management of GAD. Study Type - A Quasi-Experimental study with pre and post test study Outcome - Evidence based Efficacy of homoeopathy in managing GAD |