| CTRI Number |
CTRI/2024/07/070178 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study done inorder to access the sleep disturbance in people who are having increased screen time and also the action of the homoeopathic medicine Nux Vomica in treating the sleep disturbance |
|
Scientific Title of Study
|
Prospective study on the effectiveness of Nux vomica in Insomnia due to increased screen time by Insomnia severity index |
| 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 JINO SAIRA KOSHY |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
4th floor, Department of
Psychiatry, Sarada Krishna Homoeopathic Medical
College, Kulasekharam, Kanniyakumari District
Tamil Nadu
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
8903489348 |
| Fax |
|
| Email |
koshyjino98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr DIANA R |
| Designation |
Associate Professor and Head |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
4th floor, Department of
Psychiatry, Sarada Krishna Homoeopathic Medical
College, Kulasekharam, Kanniyakumari District
Tamil Nadu
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 and Head |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
4th floor, Department of
Psychiatry, Sarada Krishna Homoeopathic Medical
College, Kulasekharam, Kanniyakumari District
Tamil Nadu
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 District
Tamil Nadu, India
Pin :-629161
|
|
|
Primary Sponsor
|
| Name |
Post Graduate research funded by Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada Krishna Homoeopathic Medical
College, Kulasekharam, Kanniyakumari District
Tamil Nadu
Pin :-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 JINO SAIRA KOSHY |
Sarada Krishna Homoeopathic Medical College |
4th floor, Department of
Psychiatry, Sarada Krishna Homoeopathic Medical
College, Kulasekharam, Kanniyakumari District
Tamil Nadu
Room no :-510 Kanniyakumari TAMIL NADU |
8903489348
koshyjino98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NUX VOMICA |
Nux vomica will be prescribed according to symptom similarity.
Potency will be selected based on the susceptibility of patient. Follow up will be done every 3 weeks for a period of 6 months. Medicine will be administered orally. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group between 19 to 64years
Both sexes.
Patient who uses screen for more than 8 hours.
|
|
| ExclusionCriteria |
| Details |
Patients who are suffering from insomnia due to other etiological factors.
Conditions like Anxiety, Depression, Schizophrenia or any other physical factors. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness of Homoeopathic Medicine Nux Vomica will be assessed based on the improvement in the score of Insomnia severity index scale of the patients suffering with Insomnia. |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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="2" Months="0" 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 disturbance of normal sleep patterns commonly characterized by difficulty in initiating or maintaining sleep. Screen time is the amount of time spent using a device with a screen such as smartphone, computer, television. The positive or negative health effects on screen are influenced by the level of exposure. Screen time can impact the quality of sleep. Screens emit blue light known to suppress melatonin production, a hormone crucial for regulating sleep. It can decrease both sleep duration and quality. According to ICD-11, Insomnia (7A0) or sleeplessness is characterized by the complaint of persistent difficulty with sleep initiation, duration, consolidation or quality that occurs despite adequate opportunity and circumstances for sleep, and results in some form of daytime impairment and disturbance of normal sleep patterns commonly characterized by difficulty in initiating or maintaining sleep. Nux vomica finds as an effective medicine in treating Insomnia. It is helpful for those who have difficulty in falling asleep due to overactive mind or work-related stress.The assessment of the quality of sleep will be done using Insomnia Severity Index. A regular followup for 6 months will be done for each patient. |