FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092910 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Can personalized homeopathic remedies help people sleep better? A study using the Insomnia Severity Index scale 
Scientific Title of Study   Effectiveness of individualized homoeopathic remedies in treating non-organic insomnia assessed using insomnia severity index scale- A clinical 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 Jovitha J 
Designation  PG Scholar 
Affiliation  Sarada krishna homoeopathic medical college 
Address  Room no:513, 4th floor, Department of Psychiatry, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District Tamil Nadu Kanniyakumari TAMIL NADU 629161 India

Kanniyakumari
TAMIL NADU
629161
India 
Phone  7395888335  
Fax    
Email  jovishree03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Diana R 
Designation  Associate professor & Head 
Affiliation  Sarada krishna homoeopathic medical college 
Address  Room no:510, 4th floor, Department of Psychiatry, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District Tamil Nadu Kanniyakumari TAMIL NADU 629161 India

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9663475174  
Fax    
Email  dr.diana.r@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Diana R 
Designation  Associate professor & Head 
Affiliation  Sarada krishna homoeopathic medical college 
Address  Room no:510, 4th floor, Department of Psychiatry, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District Tamil Nadu Kanniyakumari TAMIL NADU 629161 India

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9663475174  
Fax    
Email  dr.diana.r@gmail.com  
 
Source of Monetary or Material Support  
Institution- Sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari, Tamilnadu 629161 
 
Primary Sponsor  
Name  Post Graduate research funded by sarada krishna homoeopathic medical college 
Address  Sarada Krishna Homoeopathic Medical College Kulasekharam Kanniyakumari 629161 
Type of Sponsor  Private medical college 
 
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 Jovitha J  Sarada krishna homoeopathic medical college  Room no 513, Fourth fllor Department of psychiatry
Kanniyakumari
TAMIL NADU 
7395888335

jovishree03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Srada krishna homoeopathic medical college-Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homoeopathic remedies  After detailed case taking Individualized Homoeopathic Remedy is prescribed based on symptom similarity remedies will be selected either by repertorized or non repertorized approach. Medicines would be changed based on the symptoms during future follow ups. Follow up is done every two weeks of medication and the case is followed up to a duration of 6 months 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients suffering with insomnia with duration more than 1 month
Etiological factors- Inadequate sleep environment, Work schedule, Poor sleep habits, Caffeine intake, Soft drinks intake, Usage of technologies included
 
 
ExclusionCriteria 
Details  Patients with history of psychiatric disorders
Patients with organic causes of insomnia
Patients with current use of medications that interferes with sleep patterns
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment is done every two weeks of medication and the case is followed up to a period of 6 months  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
The effectiveness of Individualized Homoeopathic Remedies in non-organic insomnia will be assessed based on improvement in the sleep pattern using Insomnia Severity Index score.   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)   30/08/2025 
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="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  

Insomnia is a condition of unsatisfactory quantity and/or quality of sleep, which persists for a considerable period of time. The actual degree of deviation from what is generally considered as a normal amount of sleep should not be the primary consideration in the diagnosis of insomnia because some individuals obtain a minimal amount of sleep and yet do not consider themselves as insomniacs.  The individualized homoeopathic remedy is prescribed in assessing the efficacy in treating non organic insomnia and the potency selected is based on the severity of symptom and the susceptibility of the patient suffering from non organic insomnia.  When left untreated it might lead to cognitive impairment  general malaise decreased mood and irritability with prior daytime impairment Procedure- The patient is assessed with Insomnia Severity Index Scale for assessing the severity of nonorganic insomnia before homoeopathic intervention. After detailed case taking individualized homoeopathic remedy is prescribed. Medicine would be changed based on the symptoms during future follow-ups. Outcome-Assessment is done every two weeks of medication and the case is followed up to a period of 6 months

 
Close