| CTRI Number |
CTRI/2025/02/080042 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of generalised anxiety disorder |
|
Scientific Title of Study
|
A study to assess the role of an individualised homoeopathic medicine in the management of generalised anxiety disorder in young and middle age group patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUKRITI JAISWAL |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
STATE NATIONAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL LUCKNOW |
| Address |
Department of Organon of medicine and Homoeopathic philosophy ,State National Homoeopathic Medical College and hospital,1 viraj khand gomtinagar lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9453271995 |
| Fax |
|
| Email |
sjnhmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VISHWAJEET GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
STATE NATIONAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL LUCKNOW |
| Address |
Department of community medicine ,State National Homoeopathic Medical College and hospital 1 viraj khand gomtinagar lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9893371517 |
| Fax |
|
| Email |
drvishwajeetgupta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VISHWAJEET GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
STATE NATIONAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL LUCKNOW |
| Address |
Department of community medicine ,State National Homoeopathic Medical College and hospital 1 viraj khand gomtinagar lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9893371517 |
| Fax |
|
| Email |
drvishwajeetgupta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and hospital 1 viraj khand gomtinagar, lucknow , Uttar Pradesh 226010 |
|
|
Primary Sponsor
|
| Name |
SUKRITI JAISWAL |
| Address |
Department of Organon of medicine and Homoeopathic philosophy ,State National Homoeopathic Medical College and hospital,1 viraj khand gomtinagar lucknow Uttar Pradesh 226010 |
| 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 |
| SUKRITI JAISWAL |
State National Homoeopathic Medical College and Hospital |
Department of Organon of medicine and Homoeopathic philosophy, State National Homoeopathic Medical College and Hospital Virajkhand 1 Gomti Nagar Lucknow U P 226010
Lucknow
UTTAR PRADESH |
9453271995
sjnhmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE OF STATE NATIONAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
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 |
INDIVIDUALISED HOMOEOPATHIC MEDICINE |
Intervention is planned as administering individualised homoeopathic medicine to a group of 30 patients suffering from generalised anxiety disorder after detailed case taking and repertorisation. Individualised homoeopathic medicine will be given in varying potencies of centesimal scale depending upon susceptibility of patients.Dose shall consist of 4 to 5 globules of cane sugar medicated with single medicine to be taken orally on empty stomach. Dosage and repetition will depend on individual requirement of the cases. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The sample includes patients of 14 to 60 years old age group of both sexes.
Patient fulfilling Diagnostic and statistical manual of mental disorders 5 criteria
Diagnosed cases taken after psychiatric consultation.
Informed and written consent.
Patients willing to have regular follow ups.
|
|
| ExclusionCriteria |
| Details |
Patients below the age of 14 and over the age of 60 years.
Patients with any endocrine disease i.e Hyperthyroidism, Cushing’s syndrome etc.
Patients with chronic systemic illness.
Subjects with developmental disorders like autism and down’s syndrome.
Subjects with comorbid anxiety disorder like OCD, panic disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hamilton anxiety rating scale |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified naranjo criteria for Homeopathy |
BASELINE AND 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/02/2025 |
| 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
|
|
It is a study to assess the role of an individualised Homoeopathic
medicine in management of Generalised anxiety disorder in young and middle
age group patients. The improvement of the patients will be measured using Hamilton anxiety rating scale . This study uses an individualised Homoeopathic medicine selected on the basis of symptom similarity. The doses and repetition of medicine will be as per the susceptibility of patients. It involves analysis of the case and proper repertorisation on basis of totality of symptoms. Sample size involves 30 patients. Followups will be done up to 6 months at interval of 15 days. This study also shortlists the group of medicines that will be effective in management of Generalised anxiety disorder. This study will also help in improving the quality of life of patients suffering from Generalised anxiety disorder.
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