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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [guptavaishali97099@gmail.com].

  6. 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.

  7. 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.
 
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