| CTRI Number |
CTRI/2024/03/064757 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of chronic sleeplessness |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the management of chronic insomnia in adults: Double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-5442 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saima Shamim |
| Designation |
Reader |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept.of Materia Medica (PG2 OPD) and Medicine OPD(Room no. 1) of 12, Gobinda Khatick Road, Tangra, Kolkata-700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
7059526218 |
| Fax |
|
| Email |
drsaima_7@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bidisha Ray |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept.of Materia Medica (PG2 OPD) and Medicine OPD(Room no. 1) of 12, Gobinda Khatick Road, Tangra, Kolkata-700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9163969154 |
| Fax |
|
| Email |
bidisharay66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bidisha Ray |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept.of Materia Medica (PG2 OPD) and Medicine OPD(Room no. 1) of 12, Gobinda Khatick Road, Tangra, Kolkata-700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9163969154 |
| Fax |
|
| Email |
bidisharay66@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata -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 |
| Dr Saima Shamim |
D. N. De Homoeopathic Medical College and Hospital |
Department of Medicine (room no 1) and Materia Medica OPD (PG2), 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
7059526218
drsaima_7@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee of D. N. De Homoeopathic Medical College and Hospital |
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 |
| Comparator Agent |
Identical looking placebo plus concomitant care |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm.
Duration of therapy: 3 months.
Both medicines and placebos will be re-packed in identical glass bottles and labelled with code, name of medicine, potency, and will be dispensed according to the random number list.Concomitant care: All the enrolled patients will be given concomitant care during this 3 months of therapy which are as follows: a) the-bedroom dark, quiet and cool. (b)Avoidance of sleep disturbing substances, such as caffeine, nicotine and alcohol, vigorous exercises particularly close to bedtime. (c)Additionally, a wind down routine can be helpful in readying a patient for bed.This should include discontinuation of arousing activities, including exposure to bright light (e.g., computer screen), which can negatively affect ones circadian rhythms.(d) Relaxation and paradoxical intention(e) Diaphragmatic breathing, the tensing and relaxing of muscle groups, and possibly visual imagery. Paradoxical intention is premised on the idea that anxiety about falling asleep is inhibiting sleep onset. Using this technique, patients are asked to stay as long as possible, which leads to reduced anxiety and easier sleep onset. (g) A high intake of fish and vegetables, milk and dairy products has a positive effect on sleep. Fatty fish is rich in vitamin D and omega-3 fatty acids. Vitamin D deficiency is associated with sleep disorders, Carbohydrate quality is important in determining sleep quality.(h)Yoga therapy: Yoga Nidra,kundalini yoga, viparita Karani, padangusthana, Baddha konasana, Uttana shishosana, Brahmi pranayama etc. Duration of therapy: 3 months |
| Intervention |
Individualized homoeopathic medicines in centesimal potency plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Provision will be kept to change the medicines or potencies and adjust the dosage in subsequent visits whenever required following the principles of classical homoeopathy and such instances will be compared between groups.
Duration of therapy: 3 months.
Concomitant care: All the enrolled patients will be given concomitant care during this 3 months of therapy which are as follows: a) the-bedroom dark, quiet and cool. (b)Patients should also be reminded not to consume sleep disturbing substances, such as caffeine, nicotine and alcohol, particularly close to bedtime. (c)Similarly, vigorous exercise three to four hours prior to bedtime should be avoided. (d)Additionally, a wind down routine can be helpful in readying a patient for bed.This should include discontinuation of arousing activities, including exposure to bright light (e.g., computer screen), which can negatively affect ones circadian rhythms.(e) Relaxation and paradoxical intention: These behavioural techniques complement stimulus control and sleep restriction by providing the patient with tools for decreasing arousal prior to bedtime and in the event of nighttime awakenings.(f) Relaxation techniques vary, but typically include diaphragmatic breathing, the tensing and relaxing of muscle groups, and possibly visual imagery. Using this technique, patients are asked to stay as long as possible, which leads to reduced anxiety and easier sleep onset. (g) A high intake of fish and vegetables, milk and dairy products has a positive effect on sleep. Fatty fish is rich in vitamin D and omega-3 fatty acids. Vitamin D deficiency is associated with sleep disorders, Carbohydrate quality is important in determining sleep quality.(h)Yoga therapy: Yoga Nidra,kundalini yoga, viparita Karani, padangusthana, Baddha konasana, Uttana shishosana, Brahmi pranayama etc. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient suffering from Chronic insomnia [ICD 11 Code: 7A00]
2.Insomnia severity index score more than 7.
3.Age 18 to 65 years and of either sex.
4.Participants having prior experience or knowledge of the treatment. Example- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
|
|
| ExclusionCriteria |
| Details |
1.presence of a significant current medical like cancer or neurological disorder such as dementia, Parkinson disease which compromises sleep.
2.presence of a major psychopathology like major depressive disorder, anxiety disorders.
3.Alcohol or drug abuse during the past year.
4.Evidence of another sleep disorder such as sleep apnea that is apnea-hypopnea index more than 15 or periodic limb movements during sleep that is myoclonic index with arousal more than 15.
5.A score of 7 or low on Insomnia Severity Index
6.Use of psychotropic or other medications known to alter sleep (e.g. bronchodilators) and (g)use of a sleep-promoting agent (e.g. benzodiazepines).
7.Uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life.
8.Patients who are too sick for consultation.
9.Pregnant and puerperal women, and lactating mothers.
10.Substance abuse and/or dependence.
11.Self-reported immune-compromised state.
12.Undergoing Homoeopathic treatment for any chronic disease within last 6 months.
13.Uncontrolled hypertension, diabetes, nephritic syndrome, renal insufficiency, uncontrolled hypothyroidism, severe or active liver diseases or any other uncontrolled systemic diseases affecting quality of life or organ failure.
14.Vulnerable population- unconscious, non-ambulatory, too sick for consultation, differently abled, terminally and critically ill patient, mentally unstable patients.
15.Patient not providing with written informed consent voluntarily.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pittsburg Sleep Quality Index (PSQI) |
At baseline, every month, 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Insomnia Severity Index (ISI) |
At baseline, every month, up to 3 months |
| Daily Sleep Diary with Master Sleep Diary Calculator (MSD) |
At baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/04/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsaima_7@yahoo.com and bidisharay66@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 30-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Insomnia is defined by the presence of an individual’s report of difficulty with sleep. Chronic insomnia is a frequent and persistent difficulty of initiating or maintaining sleep that occurs despite adequate opportunity and circumstances for sleep and that results in general sleep dissatisfaction and some form of daytime impairment. Daytime symptoms typically include fatigue, depressed mood or irritability, general malaise and cognitive impairment. The sleep disturbances and associated with symptoms occurs at least several times per week for at least 3 months. Absence of daytime symptoms are not considered as chronic insomnia. The Diagnostic and statistical Manual of Mental Disorders, 5th edition and ICSD-3, which have similar criteria for making the diagnosis. These criteria specify that symptoms must cause clinically significant functional distress or impairment be present for at least 3 nights/week for at least 3 months and not linked to other sleep, medical or mental disorders. In homoeopathy 4 randomized controlled trials done in which compared homoeopathic medicines to placebo. All involved small number of patients and were low methodological quality. None demonstrated a statistically significant difference in outcomes between groups, although two showed a trend favouring homoeopathic medicines and 3 demonstrated significant improvement from baseline in both groups. Existing RCTs were of poor quality and were likely to have been underpower. So there is need to undertake a trial to assess whether IHMs could produce any significant effect differ than placebo in adults suffering from chronic insomnia. Primary outcome measure will be used in this trial PSQI and Secondary outcome measures will be ISI and Daily Sleep Diary with Master Chart Calculator. All the outcome measures will be assessed at baseline, every month up to 3 months of follow up. Group differences will be measured statistically. Results will be published in a scientific journal. |