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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  
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 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  
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 
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.

 
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