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
|
|
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
|
|
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. |