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CTRI Number  CTRI/2024/04/065298 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical study to assess the effects of Homoeopathic medicines in nightmare disorder 
Scientific Title of Study   An Assessment to understand the Hahnemanns guidelines to mental diseases in the Homoeopathic management of nightmare disorder in age group 10-40 years. 
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 Saloni Raje 
Designation  Doctor, PG Scholar 
Affiliation  BVDU homoeopathic medical college and hospital 
Address  Bharati Vidyapeeth(Deemed to be university) Homoeopathic medical college and hospital, Dept of post graduate and research Centre, Pune-Bangalore highway, Pune,411043 Maharashtra, India.

Pune
MAHARASHTRA
411043
India 
Phone  7768800405  
Fax    
Email  saloniraje78@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ass Prof Dr Vinodini Patil 
Designation  MD(HOM), Ass. Prof. Dept. of Oraganon of Medicine 
Affiliation  BVDU Homoeopathic medical college and hospital 
Address  Bharati Vidyapeeth(Deemed to be university) Homoeopathic medical college and hospital, Dept of post graduate and research Centre, Pune-Bangalore highway, Pune,411043 Maharashtra, India.

Pune
MAHARASHTRA
411043
India 
Phone  9890127840  
Fax    
Email  vinodini.patil@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Ass Prof Dr Vinodini Patil 
Designation  MD(HOM), Ass. Prof. Dept. of Oraganon of Medicine 
Affiliation  BVDU Homoeopathic medical college and hospital 
Address  Bharati Vidyapeeth(Deemed to be university) Homoeopathic medical college and hospital, Dept of post graduate and research Centre, Pune-Bangalore highway, Pune,411043 Maharashtra, India.

Pune
MAHARASHTRA
411043
India 
Phone  9890127840  
Fax    
Email  vinodini.patil@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth(Deemed to be university) Homoeopathic medical college and hospital, Dept of post graduate and research Centre, Pune-Bangalore highway, Pune,411043 Maharashtra, India. 
 
Primary Sponsor  
Name  Dr. Saloni Raje 
Address  Bharati vidyapeeth(deemed to be university)Homoeopathic Medical college and hospital, Dept of post graduation and research centre Pune Bangalore highway, Pune, 411043  
Type of Sponsor  Other [self] 
 
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 Saloni Raje  BVDU Homoeopathic Medical College and Hospital, Dept of post graduate and research centre  Room No.3, Dept of Homoeopathic Philosophy & Organon of Medicine , Bharati vidyapeeth(deemed to be university)homoeopathic medical college and hospital , dept of post graduation and research centre, pune- banglore highway, Pune, MAHARASHTRA
Pune
MAHARASHTRA 		 7768800405

saloniraje78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F515||Nightmare disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicines  Homoeopathic medicine will be prescribed at the beginning of the study and at every follow up ( with duration of every 15th day for 10 weeks).Potentised homoeopathic medicine will be used in the form of pills or powder. Route of administration: Oral Selection of potency: The drug will administered in various potencies(30,200,1M etc) as per the need of patient. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients fulfilling the diagnostic criteria.
2.Patients opting for homoeopathic treatment for their illness.
3.Patients complying for regular follow up. 
 
ExclusionCriteria 
Details  1.Patients undertaking any other mode of treatment along with homoeopathic mode of treatment
2.Patients who have not filled the consent form
3.Pregnant & lactating females. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Hahnemann’s guidelines of mental diseases in the homoeopathic management of
nightmare disorder in both sexes of age group 10-40 years 		 The nightmare distress scale will be used for the assessment. For effective evaluation, disease intensity is going to be graded in every patient based on their presentation observed during case taking.  
 
Secondary Outcome  
Outcome  TimePoints 
To find out the efficacy of homoeopathic
medicines in the
management of nightmare disorder.  		 The follow ups taken for about two & a half months ( on every 15th day of the subsequent 10 weeks) will be used to assess the efficacy of Homoeopathic medicines in the management of nightmare disorder by using nightmare distress scale before & after the treatment. 
 
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 
Date of First Enrollment (India)   20/04/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Title: An Assessment to understand Hahnemann’s guidelines to mental diseases in the homoeopathic management of Nightmare disorder in the age group of 10-40 years.

It is a non-randomized interventional study with duration of 18 months on 30 patients at BVDUHMC Pune.
The primary objective will be to study the effectiveness of Hahnemann’s guidelines of mental diseases in the homoeopathic management of nightmare disorder.
And, the secondary objectives will be: 1. To study the effectiveness of Homoeopathic medicines in the treatment of nightmare disorder. 2. To review the homoeopathic literature pertaining to dreams.

Firstly, survey will be done through google screening forms which will be in three languages i.e. English, Hindi, Marathi. About 60-70 patients will be screened for nightmare disorder. Cases justifying case definition will be taken. Following screening using inclusion & exclusion criteria, eligible patients will be recruited into the study. A proper case taking & individualisation of each case will be done. Appropriate homoeopathic remedy will be selected based upon the homoeopathic principles. The time duration of the study will be 18 months. Follow up will be every 15 days. 
 
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