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CTRI Number  CTRI/2024/04/065217 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Investigation to evaluate the effectiveness of kalium phosphoricum and individualized homoeopathic medicine in cases of chronic insomnia  
Scientific Title of Study   A comparative study to assess the efficacy of individualized homoeopathic medicine and kalium phosphoricum in cases of chronic insomnia  
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 Ristez Chowdhury 
Designation  MD(PG Scholar) 
Affiliation  Bharati vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital 
Address  Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College And Homoeopathic Hospital,Dept Of Post Graduate And Research Centre Pune Bangalore Highway,Pune

Pune
MAHARASHTRA
411043
India 
Phone  8777451290  
Fax    
Email  dr.ristezchowdhury@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha VJadhavrao 
Designation  Asst.prof 
Affiliation  Bharati vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital 
Address  Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College And Homoeopathic Hospital,Dept Of Post Graduate And Research Centre Pune Bangalore Highway,Pune

Pune
MAHARASHTRA
411043
India 
Phone  9923003441  
Fax    
Email  neha.jadhavrao@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ristez Chowdhury 
Designation  MD(PG Scholar) 
Affiliation  Bharati vidyapeeth (deemed to be university) Homoeopathic Medical College and Homoeopathic Hospital 
Address  Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College And Homoeopathic Hospital,Dept Of Post Graduate And Research Centre Pune Bangalore Highway,Pune

Pune
MAHARASHTRA
411043
India 
Phone  8777451290  
Fax    
Email  dr.ristezchowdhury@gmail.com  
 
Source of Monetary or Material Support  
B.V.D.U. Homoeopathic Medical College and Hospital,Dept.of post graduate and Research centre. 
 
Primary Sponsor  
Name  Dr Ristez Chowdhury 
Address  Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College And Homoeopathic Hospital,Dept Of Post Graduate And Research Centre Pune Bangalore Highway,Pune  
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 Ristez Chowdhury  BVDU Homoeopathic Medical College and Hospital,Dept Of Post Graduate And Research Centre  Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College And Homoeopathic Hospital,Dept Of Post Graduate and Research centre Pune-Bangalore Highway,Pune
Pune
MAHARASHTRA 		 8777451290

dr.ristezchowdhury@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: G470||Insomnia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic Medicine  Potentised Homoeopathic medicine in the form of pills or powder.Route of administration:Oral selection Potency: The drug will be administered in various potencies(30,200,1M)as per need of the patient. 
Comparator Agent  Kalium Phoshphoricum  The drug will be administered in required (lower potency to 1M)potency in centesimal scale 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects Should fulfil the diagnostic criteria by ICSD III (Insomnia should be 3 nights/week for more than 3 months).Subjects within the range of age group of 18-60 years of any sexes.The patient is willing and able to comply with trial requirements. 
 
ExclusionCriteria 
Details  Subjects having drug- induced insomnia, substance abuse and/or dependence.Those cases suffering from uncontrolled systemic illness (like benign hypertrophy of prostate, diabetes mellitus and hypertension) or life-threatening infections, cases already undergoing homoeopathic treatment for any chronic disease, patients with psychiatric diseases and self-reported immune-compromised states. Pregnant and lactating women. Subjects having Insomnia due to lack of opportunity and circumstances for sleep. Previous participation in any clinical trial/proving in the last 3 months. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study and prescribe Homoeopathic medicine in cases of Chronic insomnia.  To study and prescribe Homoeopathic medicine in cases of chronic insomnia.Every follow up will be taken after 7-15 days for 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effectiveness of Individualised Homoeopathic medicine & Kalium phosphoricum in cases of Chronic Insomnia.  The follow up taken for 3 months will be assessed by Sleep Diary & Insomnia severity index scales during every follow up. 
 
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)  Open to Recruitment 
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
Modification(s)  		 This study is a randomized, single-blinded comparative clinical trial to study and prescribe medicines in cases of chronic insomnia. The duration of treatment is 3 months and will be done on 30 patients at BVDUHMC, Pune. The results of patients will be assessed by using sleep diary and insomnia severity index scales before and after treatment.  
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