| CTRI Number |
CTRI/2024/05/067109 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic medicine in 50-millesimal
scale in the management of insomnia associated with stress |
|
Scientific Title of Study
|
Role of individualised homoeopathic medicine in 50-millesimal
scale in the management of insomnia associated with stress- an
open label single arm pre-post comparison trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Saxena |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no: 14,
Department of Organon of Medicine.
National Institute of Homoeopathy, GE Block, Sector - III, Salt lake,
Kolkata - 700106
West Bengal
India
Kolkata WEST BENGAL 700106 India |
| Phone |
8920317130 |
| Fax |
|
| Email |
akankshasaxena22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Subhas Singh |
| Designation |
Professor and HOD |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no: 14,
Department of Organon of Medicine.
National Institute of Homoeopathy, GE Block, Sector - III, Salt lake,
Kolkata - 700106
West Bengal
India
Kolkata WEST BENGAL 700106 India |
| Phone |
9830644223 |
| Fax |
|
| Email |
drssubhas@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Subhas Singh |
| Designation |
Professor and HOD |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no: 14,
Department of Organon of Medicine.
National Institute of Homoeopathy, GE Block, Sector - III, Salt lake,
Kolkata - 700106
West Bengal
India
WEST BENGAL 700106 India |
| Phone |
9830644223 |
| Fax |
|
| Email |
drssubhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, GE Block, Sector- III, Salt lake, Kolkata- 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
GE Block, Sector- III, Salt lake, Kolkata- 700106 |
| 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 Akanksha Saxena |
National Institute of Homoeopathy |
OPD no: 14
Department Of
Organon of Medicine,
GE Block, Sector – III,
Salt Lake, Kolkata –
700106
Kolkata
WEST BENGAL Kolkata WEST BENGAL |
8920317130
akankshasaxena22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine in 50-millesimal
scale |
All patients will be prescribed Individualized Homoeopathic Medicine after detailed case taking in accordance with the directions given by Dr. Samuel Hahnemann in Organon of Medicine 6th Edition.Patient will be given Individualized Homoeopathic Medicine in 50 millesimal
potencies after repertorisation as per need and consulting the homoeopathic Materia
Medica.
Repetition of dose will be done following strict homoeopathic
principles.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of all sexes suffering from Insomnia (ICD-10-CM Diagnosis code: G47.01
)
associated with stress.
2. Patients from all religion and socio-economic backgrounds.
3. Patient who are aged between 18-65 years.
4. Patients with ability to read/write/understand Hindi or English or Bengali.
5. Patient who are willing to participate in the study and giving informed written
consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are too sick for consultation
2.Patient not willing to take part in the study and not ready to give written consent for
the same.
3.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
4.Lactating or Pregnant Women.
5. Undergoing Homoeopathic treatment for any chronic disease from other physician.
6. Patients who are taking allopathic medicines for Insomnia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insomnia Severity Index (ISI) |
at Baseline and after 6th Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perceived Stress Scale(PSS) |
at Baseline & after 6th Month |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Sleep disorder like Insomnia remains a prevalent public health concern, impacting substantial portions of the population at various stages in their lives. Insomnia refers to the condition of experiencing inadequate sleep, typically characterized by challenges in both falling asleep as well as staying asleep and might result in daytime sleepiness. Insomnia disorder affects around 10% of the adult population, whereas approximately 20% of individuals experience occasional symptoms of insomnia. Furthermore, it tends to persist as a chronic condition, with a 40% prevalence rate over a span of five years.Stress, anxiety and depression are among the most common. Studies show that stress in day-to-day life negatively impacts sleep quality and quantity. Dissatisfaction with sleep often exacerbates the stress and this becomes a vicious cycle. Individuals afflicted with insomnia often express dissatisfaction with their sleep patterns, which in turn can significantly impair their ability to perform effectively in various domains such as work, school, and social interactions. Studies show that stress plays an important factor in development of various psychosomatic and somatic disorders and hence it is very important that its relationship with insomnia must be studied in great depth. Homoeopathy is a holistic system of medicine which considers man as a whole, taking note of all the alterations in mind, disposition and body and forms the totality of symptoms which becomes the basis of prescription. Hence homoeopathy works well in treating cases of insomnia that may be associated with changes in mind and disposition.Accordingly, the purpose of this investigation is to evaluate the efficacy of individualized homeopathic medicine in alleviating insomnia symptoms in patients who report experiencing significant stress. A Prospective, Non randomized, Open label, Single arm, Pre- Post Comparison trial with a sample size of 40 patients of Insomnia associated with stress satisfying inclusion and exclusion criteria shall be enrolled for the study. The primary objective is to determine the role of individualized homoeopathic medicine in 50 millesimal scale in the patients of insomnia associated with stress by evaluating changes in Insomnia Severity Index (ISI) at baseline and after 6 months of treatment. The secondary objective is to evaluate changes in Perceived Stress Scale (PSS) using individualized homeopathic medicine in 50 millesimal scale in patients of insomnia associated with stress at baseline and after 6 months of treatment.The sociodemographic data, Insomnia Severity Index and Perceived Stress Scale Score data will be collected once at the Baseline and then after 6 months.The descriptive data will be recorded in terms of absolute values, percentages etc. as appropriate. The score obtained by the patients will be compared and result analysed as per appropriate statistical methods and inference will be done thereafter. The result will be published in scientific journals.
|