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CTRI Number  CTRI/2024/10/075116 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 27/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Role of Homoeopathic medicine in Insomnia  
Scientific Title of Study   Role of Individualised Homoeopathic medicine in cases of insomnia by using 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 Durvi Pathak 
Designation  PG Scholar 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College and Hospital 
Address  Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University,P.O.Limda, Ta.Waghodia, Dist. Vadodara, Vadodara.

Vadodara
GUJARAT
391760
India 
Phone  7778012021  
Fax    
Email  durvi.in@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devendra Jadav 
Designation  PROFESSOR, PRACTICE OF MEDICINE DEPARTMENT 
Affiliation  Jawaharlal Nehru Homoeopathic Medical college and Hospital 
Address  Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University,P.O.Limda, Ta.Waghodia, Dist. Vadodara, Vadodara.

Vadodara
GUJARAT
391760
India 
Phone  9825222758  
Fax    
Email  devendrasinhjadav207@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Durvi Pathak 
Designation  PG Scholar 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College and Hospital 
Address  Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University,P.O.Limda, Ta.Waghodia, Dist. Vadodara, Vadodara.

Vadodara
GUJARAT
391760
India 
Phone  7778012021  
Fax    
Email  durvi.in@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Homoeopathic Medical College And Hospital, Parul University, P.O.Limda, Ta.Waghodia, Dist. Vadodara, Vadodara, Gujarat 391760 India 
 
Primary Sponsor  
Name  Jawaharlal Nehru Homoeopathic Medical And Hospital 
Address  Jawaharlal Nehru Homoeopathic Medical College, Department of Practice of Medicine, Post graduation division, Parul University, P.O.Limda, Ta.Waghodia, Dist.Vadodara, Vadodara, Gujarat 391760 
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 Durvi Pathak  Jawaharlal Homoeopathic Medical College And Hospital  Jawaharlal Nehru Homoeopathic Medical College,Department of Practice of Medicine,Post graduation division, Parul University, P.O.Limda,Ta.Waghodia,Dist. Vadodara.
Vadodara
GUJARAT 		 7778012021

durvi.in@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Homoeopathic Medical College And Hospital INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G470||Insomnia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualistic Homoeopathic medicine   An Individualized homeopathic medicine of potency 30,200 or 1M to be given in BD, TDS or frequent repetition as per need,follow up is to be done every 15 days for consecutive three months 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Cases pre-diagnosed or with clinical presentation of insomnia will be randomly
selected. Patients fulfilling the diagnostic criteria by DSM 5
2.Age- between 18 years to 60 years
3.Gender- both male and female.
4.All socio economic status 
 
ExclusionCriteria 
Details  1.Cases having advanced pathology.
2.Cases with other systemic disease.
3.Cases with irregular follow up.
4.Pregnant and lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TO ASSESS THE IMPROVEMENT OF INSOMNIA USING INSOMNIA
SEVERITY INDEX (ISI) WITH HOMOEOPATHIC INDIVIDUALISED
MEDICINES BEFORE AND AFTER TREATMENT 		 follow up to be done after 15 days, Assesement to be done every month for next three month from first visit. 
 
Secondary Outcome  
Outcome  TimePoints 
TO STUDY THE HOMOEOPATHIC MEDICINES WHICH ARE USEFUL IN
TREATMENT OF INSOMNIA 		 3 months 
 
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   N/A 
Date of First Enrollment (India)   15/10/2024 
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   The study is Prospective Interventional Non-randomized study. To study about role of Individualised Homoeopathic medicine in cases of insomnia which diagnosed by DSM5 criteria and assess the improvement of insomnia by  using INSOMNIA SEVERITY INDEX (ISI) with  Individualised Homoeopathic medicines before and after treatment and to study the  Homoeopathic medicines which are useful in treatment of insomnia. 



 
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