| CTRI Number |
CTRI/2025/06/089240 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic medicine for reducing insomnia in generalized anxiety disorder |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine for reducing insomnia in generalized anxiety disorder single arm prospective 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 VAISHALI GUPTA |
| Designation |
Post Graduate Scholar, |
| Affiliation |
National Homoeopathic Research Institute in Mental Health |
| Address |
Dept of Psychiatry ,room number-8
National Homoeopathic Research Institute in Mental Health
Kottayam KERALA 686532 India |
| Phone |
09044639849 |
| Fax |
|
| Email |
guptavaishali97099@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S KARUNAKARA MOORTHI |
| Designation |
PROFESSOR AND RESEARCH OFFICER (H), SCIENTIST III |
| Affiliation |
National Homoeopathic Research Institute in Mental Health |
| Address |
Department of psychiatry,room number-4
National Homoeopathic Research Institute in Mental Health
Kottayam KERALA 686532 India |
| Phone |
8281502571 |
| Fax |
|
| Email |
drjaiguru@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S KARUNAKARA MOORTHI |
| Designation |
PROFESSOR AND RESEARCH OFFICER (H), SCIENTIST III |
| Affiliation |
National Homoeopathic Research Institute in Mental Health |
| Address |
Department of psychiatry,room number-4
National Homoeopathic Research Institute in Mental Health,
Kottayam KERALA 686532 India |
| Phone |
8281502571 |
| Fax |
|
| Email |
drjaiguru@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL HOMOEOPATHIC RESEARCH INSTITUTE IN MENTAL HEALTH Sachivothamapuram p.o Kurichy Kottayam kerala 686532
india |
|
|
Primary Sponsor
|
| Name |
DR VAISHALI GUPTA |
| Address |
National Homoeopathic Research Institute in Mental
Health,Sachivothamapuram p o, kurichy, kottayam,
kerala-686532,India.
|
| 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 Vaishali Gupta |
National Homoeopathic Research Institute in Mental Health |
OPD, IPD, Camps and
Peripheral Units Department of
Psychiatry, National
Homoeopathy
Research Institute in
Mental Health,
Kottayam KERALA
Kottayam
KERALA Kottayam KERALA |
8281502571
guptavaishali97099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee -National Homoeopathic Research Institute in Mental Health, Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, (2) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
individualized homoeopathic medicines |
After enrollment the case will be
repertorised. Appropriate
potentized Individualised
Homoeopathic Medicine will be
administered in minimum dose
in appropriate potency
according to the need of the
case. Medicine is administered
orally. Repetition will be done
when improvement comes to a
standstill in a higher potency ofthe same medicine and if the
medicine is not found to be
effective the case will be
retaken then another
appropriate medicine is given.
The above homoeopathic
intervention will be given for a
period of 1 year. |
| Comparator Agent |
NOT APPLICABLE |
NOY APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group between 18-60 of both sexes.
2) Participants fulfilling the DSM-5 criteria for GAD with insomnia.
3) ISI scores greater than or equal 8
|
|
| ExclusionCriteria |
| Details |
1)Participants with insomnia in psychiatric disease other than GAD.
2) Substance induced anxiety disorder.
3) Serious systemic illness (uncontrolled DM, uncontrolled HTN)
4) Pregnant and lactating women.
5) Participants with suicidal ideation.
6) Organic cause of insomnia.
7) Participants those who are taking treatment from other system of medicine for insomnia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of insomnia by assessing changes in ISI scale score.
|
Every from baseline till the conclusion of the
study (12 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of anxiety by assessing changes in HAM-A scale score. |
Every from baseline till the conclusion of the
study (12 months) |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="8" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [guptavaishali97099@gmail.com].
- For how long will this data be available start date provided 26-06-2025 and end date provided 11-11-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This open-label clinical research aims to assess the effectiveness of individualized homoeopathic treatment in reducing insomnia associated with Generalized Anxiety Disorder (GAD). The primary objective is to reduce insomnia symptoms in GAD patients using the Insomnia Severity Index (ISI). Secondary objectives include evaluating anxiety reduction before and after treatment using the Hamilton Anxiety Rating Scale (HAM-A).Participants diagnosed with insomnia in the context of GAD who visit the Outpatient Department (OPD), Inpatient Department (IPD), or Peripheral OPD at the National Homoeopathic Research Institute in Mental Health (NHRIMH), Kottayam, will be subjected to a structured screening process. Those meeting the DSM-5 diagnostic criteria for insomnia related to GAD will be enrolled after providing written informed consent..A psychiatrist will confirm the diagnosis and record a detailed case history. Routine and specific investigations will be carried out as required to eliminate other potential medical causes. Baseline assessments will include both ISI and HAM-A scores.An individualized homoeopathic totality will be constructed for each participant, and repertorization will be carried out using RADAR software in conjunction with the Synthesis Repertory. Remedies will be selected based on Homoeopathic Materia Medica. Participants will be evaluated periodically for their clinical progress. If there’simprovement, a higher potency of the same medicine may be prescribed. If there is no change, the case will be reassessed, and a new remedy may be selected.Acute symptoms will be treated as needed. Monthly follow-ups will be conducted, and both ISI and HAM-A scores will be reviewed at each visit. Participants missing three consecutive visits will be marked as dropouts and excluded from the study, though they may return later. The goal is to evaluate the effect of individualized homoeopathy in reducing insomnia in patients with GAD. |