| CTRI Number |
CTRI/2026/03/106061 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment in Generalized Anxiety Disorder |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Role of Individualized Homoeopathic Medicine among adults having Generalized Anxiety Disorder using Hamilton Anxiety Rating Scale (HAM-A) |
| 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 Sumera |
| Designation |
Post graduate scholar |
| Affiliation |
National Institute Of Homoeopathy, Delhi, A-8,Chaudhary Ramdev Chowk, Narela, Delhi-110040 |
| Address |
OPD Number 122, Department of Psychiatry, National Institute Of Homoeopathy, Delhi, A-8,Chaudhary Ramdev Chowk, Narela, Delhi-110040
North
DELHI
110040
India |
| Phone |
9205502115 |
| Fax |
|
| Email |
siddiquisumera644@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uran Tomar |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Homoeopathy, Delhi, A-8,Chaudhary Ramdev Chowk, Narela, Delhi-110040 |
| Address |
OPD number 122, Department of Psychiatry, National Institute Of Homoeopathy, Delhi, A-8,Chaudhary Ramdev Chowk, Narela, Delhi-110040
North
DELHI
110040
India |
| Phone |
9630930363 |
| Fax |
|
| Email |
uranviren11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumera |
| Designation |
Post graduate scholar |
| Affiliation |
National Institute Of Homoeopathy, Delhi, A-8,Chaudhary Ramdev Chowk, Narela, Delhi-110040 |
| Address |
OPD number 122, Department of Psychiatry, National Institute Of Homoeopathy, Delhi, A-8,Chaudhary Ramdev Chowk, Narela, Delhi-110040
North
DELHI
110040
India |
| Phone |
9205502115 |
| Fax |
|
| Email |
siddiquisumera644@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF HOMOEOPATHY,Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Sumera |
| Address |
National Institute Of Homoeopathy, Delhi, A-8,Chaudhary Ramdev Chowk, Narela, Delhi-110040 |
| 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 Sumera |
National Institute Of Homoeopathy, Delhi-110040 |
OPD Number 122, Department of Psychiatry, Sector A-8,Chaudhary Ramdev Chowk, Narela, Delhi-110040
North
DELHI |
9205502115
siddiquisumera644@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Homoeopathy,delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE |
prescribed according to the totality of symptoms. potency ,dose and repetition will be as per homoeopathic principle. all the medicine will be administered orally for 3 months. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18–65 years diagnosed with Generalized Anxiety Disorder as per Diagnostic and statistical manual of mental disorder 5 Text Revision diagnostic criteria.
2.Participants of all gender and from all socioeconomic and religious backgrounds will
be included.
3.Patients with Hamilton Anxiety scale defined mild 8–14 and moderate 15–23 anxiety are included.
4.Participants willing to participate and giving written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patients who develop severe anxiety during the study period such cases will be referred for appropriate care and excluded from the study
2.Patient currently receiving allopathic medications for anxiety disorder.
3.Presence of psychiatric comorbidities such as schizophrenia, bipolar disorder, severe depression with suicidal risk.
4.Presence of unstable or serious medical illnesses such as uncontrolled diabetes, thyroid disease, cardiovascular disease, hepatic or renal failure, neurological disorders that may interfere with treatment or assessment.
5.Pregnant and lactating mother
6.Patient taking homoeopathic medicine for any other systemic disease since last 6 month
7.Simultaneous participation in any other clinical trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered instrument for
assessing the severity of generalized anxiety disorder.
|
assessment at baseline and after 3 months of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)The causal relationship between the intervention and the clinical outcome will be
evaluated using the Modified Naranjo Criteria for Homeopathy (MONARCH)
2) Based on the MONARCH score, the therapeutic outcome will be categorized as:
(Certain equal or more than 9, Probable 5 – 8, Possible 1 – 4, Unlikely equal or less than 0).
3)ADR probability scale will be used to assess the adverse drug reactions (if any)
throughout the study.
|
Timepoint: will be measured after 3 months of treatment.
|
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 3 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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="0"
Months="6"
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
|
Generalized Anxiety Disorder (GAD) is a Chronic psychiatric condition characterized by excessive anxiety and worry occurring more days than not for at least 6 months, about a number of events or activities often accompanied by symptoms such as restlessness, fatigue, irritability, muscle tension, and sleep disturbance. It significantly affects daily functioning and quality of life. Homoeopathy emphasizes individualized treatment based on the principle of similia similibus curentur, where a medicine is selected according to the totality of symptoms of the patient. Individualized homoeopathic medicines aim to restore mental and physical balance and improve overall well-being. This single-arm pre–post clinical study aims to evaluate the role of individualized homoeopathic medicine in adults with Generalized Anxiety Disorder. A total of 38 participants aged 18–65 years diagnosed with GAD according to DSM-5 criteria and having mild to moderate anxiety (HAM-A score 8–23) will be enrolled from the OPD and IPD of the National Institute of Homoeopathy, Narela, Delhi. total study duration will be 6 months. Participants will receive individualized homoeopathic treatment for 3 months, with follow-up every two weeks. The primary outcome will be the change in anxiety severity measured using the Hamilton Anxiety Rating Scale (HAM-A) at baseline and after 3 months of treatment. The Modified Naranjo Criteria for Homeopathy (MONARCH) will be used to evaluate the causal relationship between the intervention and clinical outcome. If any ADR occur ,we will report to the competent authority and nearest pharmacovigilance centre. |