| 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
|
|
|
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
|
|
|
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 |