| CTRI Number |
CTRI/2024/02/063098 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicines in the treatment of Sleeplessness |
|
Scientific Title of Study
|
A Clinical Study on the Effectiveness of Homoeopathic Remedies Selected Based on Kent Repertory in Reducing the Severity of Chronic 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 |
NAWAS M |
| Designation |
PG SCHOLAR |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi PO Salem TAMIL NADU 636308 India
Salem
TAMIL NADU
Salem
TAMIL NADU
636308
India |
| Phone |
9600383242 |
| Fax |
|
| Email |
nawasm461@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa prasad |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory
Vinayaka Missions Homoeopathic Medical College and Hospital
NH 47 Sankari Main Road
Seeragapadi Post
Salem
TAMIL NADU
636308
India |
| Phone |
8281292904 |
| Fax |
|
| Email |
shilpaprasad007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa prasad |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory
Vinayaka Missions Homoeopathic Medical College and Hospital
NH 47 Sankari Main Road
Seeragapadi Post
Salem
TAMIL NADU
636308
India |
| Phone |
8281292904 |
| Fax |
|
| Email |
shilpaprasad007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi PO Salem TAMIL NADU 636308 India
Salem
TAMIL NADU |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH 47 Sankari Main Road
Seeragapadi Post
Salem
Tamil Nadu
636308
India
|
| 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 NAWAS M |
VINAYKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
PG
Department of
Repertory OPD Medical
Unit III Ground Floor
Hospital Block
Vinayaka Missions
Homoeopathic Medical
College and Hospital
NH 47 Sankari Main
Road Seeragapadi PO
Salem TAMIL NADU
636308 INDIA
Salem
TAMIL NADU
Salem
TAMIL NADU |
9600383242
nawasm461@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College And Hospital Salem |
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 |
Homoeopathic Remedy |
Homoeopathic medicines are
selected based on
individualization of the patient.
Based on the susceptibility of
the patient the dose is selected.
Medicine is administered via
oral route. Follow up is taken
once in every one month maximum treatment period per patient under study is 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Insomnia, screened using Sleep Condition Indicator with
score less than or equal to 16 and diagnosed based on Diagnostic and Statistical
Manual of Mental Disorders, Fifth edition (DSM-5) code 307.42 (F51.01) |
|
| ExclusionCriteria |
| Details |
Cases with life threatening conditions. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that the proposed study will be useful in reducing the severity of insomnia |
At baseline and at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of patient with insomnia is done based upon the insomnia severity index scale |
At baseline and at the end of study |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
31/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 defined as difficulties initiating or maintaining sleep, or early morning
awakening, associated with impaired daytime functioning, for example, reduced cognitive
performance, fatigue or mood disturbances. In India, 9% of people experience Insomnia, while up to 30% of people
have sleeping difficulties at some point in their lives. The Neurological Society of India
estimates that difficulty falling and staying asleep affects at least 28% of the population.Women has been noted to experience Insomnia at higher rates than men. Compared to younger
adults, older adults report more sleep difficulty and more frequent nocturnal awakenings. Subjects with chronic Insomnia have a poor quality of life, reduced work productivity
including absenteeism, increased risk of accidents, higher healthcare utilization and increased
mortality risk. Homoeopathy is a mode of treatment which is based on individualization and its holistic
approach treats effectively without adverse effect. Homoeopathy removes the cause of the disease
and restore the healthy state of the body. The Homoeopathic similimum is one of the fundamental
therapeutic procedures to treat various diseases. The present study aims at effectiveness of
homoeopathic medicines in reducing the severity of Insomnia patients using Kent repertory. Kent
repertory contains physical and mental general symptoms along with particular symptoms and
corresponding group of medicines. The remedy is selected on the basis of Generals (mental and
physical) symptoms. It can be used for repertorization of cases rich in general symptoms either
physical generals or mental generals or both along with few modalities and concomitants which
gives the complete picture of individual. |