| CTRI Number |
CTRI/2020/10/028710 [Registered on: 28/10/2020] Trial Registered Prospectively |
| Last Modified On: |
29/10/2020 |
| 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 sleep disturbance |
|
Scientific Title of Study
|
Double-blind, randomized, placebo-controlled, pilot evaluation of individualized homoeopathic medicines in insomnia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1259-6877 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asit Bhowmick |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD no. 1; 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007561011 |
| Fax |
|
| Email |
asitbhowmick900@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhasish Ganguly |
| Designation |
Professor and Head |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD no. 1; 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
ganguly.subhasish@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Shyamal Kumar Mukherjee |
| Designation |
Principal and Administrator |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Community Medicine, Division 10 (PG 1), 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 |
| 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 |
| Asit Bhowmick |
D. N. De Homoeopathic Medical College and Hospital |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD no. 1; 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046
Kolkata
WEST BENGAL |
9007561011
asitbhowmick900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All the participants will be encouraged to develop good sleep hygiene and habits such as not using bed for anything except sleep, maintaining regular sleep timings, avoiding behaviours such as napping after 3:00 pm, caffeine after lunchtime etc. which may interfere with sleep physiology. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Route of administration of medicine: Oral. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All the participants will be encouraged to develop good sleep hygiene and habits such as not using bed for anything except sleep, maintaining regular sleep timings, avoiding behaviours such as napping after 3:00 pm, caffeine after lunchtime etc. which may interfere with sleep physiology. Route of administration of medicine: Oral. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from chronic insomnia (ICD-10-CM G47.0)
2. Patients of either sex
3. Age 18-65 years
4. Literate patients; ability to read Bengali and/or English
5. Patients willing to participate in the study and giving written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients who are too unwell to take part
2. Diagnosed cases of unstable psychiatric complaints or other systemic diseases affecting quality of life
3. Currently receiving standard therapy for insomnia and/or homoeopathic treatment for any chronic condition(s)
4. Pregnant, puerperial and lactating women
5. Self-reported immune compromised conditions
6. Substance abuse and/or dependence. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Daily Sleep Diary |
At baseline and every month up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Insomnia Severity Index (ISI) |
At baseline and every month up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/10/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published later |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Insomnia can be defined as “chronic inability to fall asleep or remain asleep for an adequate length of time". The worldwide prevalence of insomnia is 10-30%. It is associated with impaired day-time functioning, reduced quality of life (QoL), increased risk of morbidity and substantial societal cost. Many patients perceived homoeopathy to be effective for such problems and several trials suggested that homoeopathy is an effective treatment for insomnia. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 60 patients suffering from insomnia will be randomized to either individualized homoeopathic medicines (verum; n=30) or identical-looking placebo (control; n=30). e aim to investigate whether there are any differences in outcomes between these two groups over 3 months of intervention. Daily sleep diary and insomnia severity index (ISI) scores will be used as the primary an secondary outcome measures respectively. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals. |