| CTRI Number |
CTRI/2025/10/095620 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
to find the effectiveness of homoeopathy in sleeplessness versus placebo trial |
|
Scientific Title of Study
|
A Randomised Placebo Controlled Clinical Trial To Assess The Effectiveness Of Individualised Homoeopathic Medicine Versus Placebo In The Management Of Insomnia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjana Balot |
| Designation |
PG Scholor |
| Affiliation |
Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur |
| Address |
Room no 4 Department of Materia Medica Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
7727910110 |
| Fax |
|
| Email |
balotsanjana3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonia Tuteja |
| Designation |
Professor |
| Affiliation |
Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur |
| Address |
Room no 4 Department of Materia Medica Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9530454132 |
| Fax |
|
| Email |
drsoniatuteja@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Sonia Tuteja |
| Designation |
Professor |
| Affiliation |
Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur |
| Address |
Room no 4 Department of Materia Medica Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9530454132 |
| Fax |
|
| Email |
drsoniatuteja@yahoo.in |
|
|
Source of Monetary or Material Support
|
| OPD 4 Girendra pal homeopathic medical college hospital and research center constituent of Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Center saipura sanganer jaipur rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur |
| Address |
Room no 4 Department of Materia Medica Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur 302029 |
| 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 Sonia Tuteja |
Dr Girendra Pal Homoeopathic hospital and Research Centre |
Room no 4 Department of Materia Medica Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur
Jaipur
RAJASTHAN |
9530454132
drsoniatuteja@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Homoepathy University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised medicine |
Potency according to susceptibility three times a day every 2 weeks |
| Comparator Agent |
Placebo |
According to susceptibility three times a day every 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age Group – 19 years to 60 years of age.
Both genders
Diagnosed with primary insomnia based on DSM-5 criteria |
|
| ExclusionCriteria |
| Details |
Patient with secondary insomnia and psychiatric conditions
Immuno-compromised patients such as suffering from HIV, Hepatitis B/C etc.
Pregnant women and lactating mothers will not be included in the study.
Cases with multi-systemic illness will be excluded from the study, and cases with advanced pathology.
Patients who are not willing to give consent.
Patients taking other treatments for insomnia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
From this study, we expect that individualized homoeopathic medicine has statistically significant beneficial
effect in improving the quality and duration of sleep in patient suffering from insomnia when compared to
placebo. |
The study will be undertaken for a period of 12 months, out of which cases will be registered in the first 9 months,
so that a minimum of 3 months of follow-ups and each follow-up in 15 days can be obtained. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
21/10/2025 |
| 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="0"
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
|
The synopsis presents a randomised placebo-controlled trial to test the effectiveness of individualized homoeopathic medicine in insomnia. 60 patients (40 on homoeopathy, 20 on placebo), aged 19–60, will be included and assessed using the Insomnia Severity Index over 3 months. The study aims to generate evidence on whether homoeopathy improves sleep quality and duration better than placebo, offering a safe, patient-centered alternative for managing insomnia |