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CTRI Number  CTRI/2017/05/008450 [Registered on: 02/05/2017] Trial Registered Prospectively
Last Modified On: 20/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathic treatment of sleeplessness 
Scientific Title of Study   Efficacy of Individualized Homoeopathic Treatment of Insomnia; Double Blind, Randomized, Placebo Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1195-7691  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  James Michael 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  OPD No. 5, Dept. of Organon of Medicine, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone    
Fax    
Email  jamesmichael312@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subhas Singh 
Designation  Reader, Dept. of Organon of Medicine 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  OPD No. 5, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  9830644223  
Fax    
Email  drssubhas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  James Michael 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  OPD No. 5, Dept. of Organon of Medicine, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone    
Fax    
Email  jamesmichael312@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt Lake, Kolkata, West Bengal 700106, India 
 
Primary Sponsor  
Name  National Institute of Homoeopathy Ministry of AYUSH Govt of India 
Address  Block GE, Sector III, Salt Lake, Kolkata, West Bengal 700106, India 
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 
James Michael  National Institute of Homoeopathy, Govt. of India  OPD 5, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal 700106, India; Monday to Saturday, 9 am to 2 pm
Kolkata
WEST BENGAL 
7044515049

jamesmichael312@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Insomnia,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Individualized homeopathic medicine in centesimal or 50 millesimal potencies  In centesimal potencies, each dose consisted of 4 cane sugar globules no. 30, moistened with a single drop of the indicated medicine, preserved in 90% v/v ethanol; repetition depending upon the individual requirement of the case and as per homeopathic principles. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) was dissolved in 90 ml of distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. Each dose was directed to be taken orally on clean tongue with empty stomach. Duration of such therapy was 3 months. 
Comparator Agent  Placebo  Each dose in centesimal scale consisted of 4 cane sugar globules no. 30, moistened with a single drop of rectified spirit; identical in appearance with and indistinguishable from the medicine. In 50 millesimal scale, a single non-medicated cane sugar globules of poppy seed size (no. 10) was dissolved in 90 ml of distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. Dosage and instructions were same as in the intervention arm. Each dose was directed to be taken orally on clean tongue with empty stomach. Duration of therapy was 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Both male and female patients
2. Age between 18 and 65 years
3. Patients with known but controlled systemic diseases
4. Patients giving written consent to participate 
 
ExclusionCriteria 
Details  1. Cases suffering from uncontrolled systemic illness or life-threatening infections
2. Cases already undergoing homoeopathic treatment elsewhere for any chronic disease
3. Self-reported immune-compromised state
4. Substance abuse and/or dependence
5. Pregnant or lactating women
6. Patients with psychiatric diseases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Sleep diary  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Insomnia Severity Index (ISI) questionnaire  3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/05/2017 
Date of Study Completion (India) 28/06/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Insomnia is the most common sleep-related complaint with a prevalence of 6-18% in the general population. In South India, 18.6% of respondents reported insomnia. Chronic insomnia, if untreated, can have social, economic and occupational impacts on the individual. Insomnia is associated with impaired day-time functioning, reduced Quality of Life, increased risk of morbidity and substantial societal cost. There are multiple placebo controlled trials with results supporting the efficacy of homoeopathic medication in insomnia; still, one systematic review recommended that future trials of homeopathy and insomnia be conducted using adequate and rigorous study designs. In this trial, the investigators intend to assess the efficacy of individualized homoeopathic treatment for insomnia on 60 patients in a double blind, randomized, parallel arm, placebo controlled design in the outpatients of National Institute of Homoeopathy, Salt Lake, Kolkata 700106, West Bengal, India. The patients will be prescribed either individualized homoeopathic medicines or identical placebo, and will be followed up for 3 months. Data will be gathered at baseline and after 3 months using sleep diary and insomnia severity index questionnaire. Randomization will be pharmacy-controlled. Code will be broken at the end of the trial after the database is frozen. The Intention to treat (ITT) population will be subjected to statistical analysis.
 
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