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CTRI Number  CTRI/2024/05/067109 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic medicine in 50-millesimal scale in the management of insomnia associated with stress 
Scientific Title of Study   Role of individualised homoeopathic medicine in 50-millesimal scale in the management of insomnia associated with stress- an open label single arm pre-post comparison trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akanksha Saxena 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy 
Address  OPD room no: 14, Department of Organon of Medicine. National Institute of Homoeopathy, GE Block, Sector - III, Salt lake, Kolkata - 700106 West Bengal India

Kolkata
WEST BENGAL
700106
India 
Phone  8920317130  
Fax    
Email  akankshasaxena22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Subhas Singh 
Designation  Professor and HOD 
Affiliation  National Institute of Homoeopathy 
Address  OPD room no: 14, Department of Organon of Medicine. National Institute of Homoeopathy, GE Block, Sector - III, Salt lake, Kolkata - 700106 West Bengal India

Kolkata
WEST BENGAL
700106
India 
Phone  9830644223  
Fax    
Email  drssubhas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Subhas Singh 
Designation  Professor and HOD 
Affiliation  National Institute of Homoeopathy 
Address  OPD room no: 14, Department of Organon of Medicine. National Institute of Homoeopathy, GE Block, Sector - III, Salt lake, Kolkata - 700106 West Bengal India


WEST BENGAL
700106
India 
Phone  9830644223  
Fax    
Email  drssubhas@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, GE Block, Sector- III, Salt lake, Kolkata- 700106 
 
Primary Sponsor  
Name  National Institute of Homoeopathy 
Address  GE Block, Sector- III, Salt lake, Kolkata- 700106 
Type of Sponsor  Government 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 Akanksha Saxena  National Institute of Homoeopathy  OPD no: 14 Department Of Organon of Medicine, GE Block, Sector – III, Salt Lake, Kolkata – 700106 Kolkata WEST BENGAL
Kolkata
WEST BENGAL 
8920317130

akankshasaxena22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of National Institute of Homoeopathy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised homoeopathic medicine in 50-millesimal scale  All patients will be prescribed Individualized Homoeopathic Medicine after detailed case taking in accordance with the directions given by Dr. Samuel Hahnemann in Organon of Medicine 6th Edition.Patient will be given Individualized Homoeopathic Medicine in 50 millesimal potencies after repertorisation as per need and consulting the homoeopathic Materia Medica. Repetition of dose will be done following strict homoeopathic principles.  
Comparator Agent  Not applicable   Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of all sexes suffering from Insomnia (ICD-10-CM Diagnosis code: G47.01
)
associated with stress.
2. Patients from all religion and socio-economic backgrounds.
3. Patient who are aged between 18-65 years.
4. Patients with ability to read/write/understand Hindi or English or Bengali.
5. Patient who are willing to participate in the study and giving informed written
consent.
 
 
ExclusionCriteria 
Details  1.Patients who are too sick for consultation
2.Patient not willing to take part in the study and not ready to give written consent for
the same.
3.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
4.Lactating or Pregnant Women.
5. Undergoing Homoeopathic treatment for any chronic disease from other physician.
6. Patients who are taking allopathic medicines for Insomnia.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Insomnia Severity Index (ISI)  at Baseline and after 6th Month  
 
Secondary Outcome  
Outcome  TimePoints 
Perceived Stress Scale(PSS)  at Baseline & after 6th Month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   20/05/2024 
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="1"
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  
Sleep disorder like Insomnia remains a prevalent public health concern, impacting substantial portions of the population at various stages in their lives. Insomnia refers to the condition of experiencing inadequate sleep, typically characterized by challenges in both falling asleep as well as staying asleep and might result in daytime sleepiness. Insomnia disorder affects around 10% of the adult population, whereas approximately 20% of individuals experience occasional symptoms of insomnia. Furthermore, it tends to persist as a chronic condition, with a 40% prevalence rate over a span of five years.Stress, anxiety and depression are among the most common. Studies show that stress in day-to-day life negatively impacts sleep quality and quantity. Dissatisfaction with sleep often exacerbates the stress and this becomes a vicious cycle. Individuals afflicted with insomnia often express dissatisfaction with their sleep patterns, which in turn can significantly impair their ability to perform effectively in various domains such as work, school, and social interactions. Studies show that stress plays an important factor in development of various psychosomatic and somatic disorders and hence it is very important that its relationship with insomnia must be studied in great depth. Homoeopathy is a holistic system of medicine which considers man as a whole, taking note of all the alterations in mind, disposition and body and forms the totality of symptoms which becomes the basis of prescription. Hence homoeopathy works well in treating cases of insomnia that may be associated with changes in mind and disposition.Accordingly, the purpose of this investigation is to evaluate the efficacy of individualized homeopathic medicine in alleviating insomnia symptoms in patients who report experiencing significant stress. A Prospective, Non randomized, Open label, Single arm, Pre- Post Comparison trial with a sample size of 40 patients of Insomnia associated with stress satisfying inclusion and exclusion criteria shall be enrolled for the study. The primary objective is to determine the role of individualized homoeopathic medicine in 50 millesimal scale in the patients of insomnia associated with stress by evaluating changes in Insomnia Severity Index (ISI) at baseline and after 6 months of treatment. The secondary objective is to evaluate changes in Perceived Stress Scale (PSS) using individualized homeopathic medicine in 50 millesimal scale in patients of insomnia associated with stress at baseline and after 6 months of treatment.The sociodemographic data, Insomnia Severity Index and Perceived Stress Scale Score data will be collected once at the Baseline and then after 6 months.The descriptive data will be recorded in terms of absolute values, percentages etc. as appropriate. The score obtained by the patients will be compared and result analysed as per appropriate statistical methods and inference will be done thereafter. The result will be published in scientific journals.

 
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