| CTRI Number |
CTRI/2023/07/055566 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Homoeopathic medicines in the treatment of insomnia by using Kent"s repertory. |
|
Scientific Title of Study
|
Effectiveness of Homoeopathic medicines in the treatment of insomnia by using repertory of the homoeopathic materia medica by J.T.Kent.An open observational prospective clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMPA RANI ROY |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Case taking and Repertory. OPD no.10
NATIONAL INSTITUTE OF HOMOEOPATHY,Block-GE,Sector-3,Saltlake .
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7029330537 |
| Fax |
|
| Email |
roysamparani11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Case taking and Repertory. OPD No.10. NATIONAL INSTITUTE OF HOMOEOPATHY,Block-GE,Sector-3,Saltlake .
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7003178867 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Case taking and Repertory. OPD No.10. NATIONAL INSTITUTE OF HOMOEOPATHY,Block-GE,Sector-3,Saltlake .
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7003178867 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy. Block-GE,Sector-3,Saltlake,Kolkata-700106 |
|
|
Primary Sponsor
|
| Name |
National institute of homoeopathy |
| Address |
OPD no 10, department of case taking and repertory,Block-GE,Sector -3,Saltlake,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 |
| Sampa Rani Roy |
National Institute of Homoeopathy |
Department of Case taking and Repertory. Room No.10.Block-GE,Sector-3,Saltlake ,Kolkata-700106
North Twentyfour Parganas
WEST BENGAL |
7029330537
roysamparani11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee ,National Institute of Homoeopathy. |
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 |
Homoeopathic medicine after repertorisation done using Repertory Repertory of Homoeopathic Materia Medica byJ.T.Kent. |
Patients qualifying to inclusion criteria will be included in the study. proper case taking of all enrolled patients will be done in standerdized case taking proforma which is being used in National Institute of Homoeopathy.The score of the patients using Self assessment score for insomnia questionnaire will be recorded at baseline ,at 3rd month and at 6th month.Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorisation using Kent"s Repertory.Indicated homoeopathic remedy will be administered as decided appropriate to the case or condition in appropriate potency and doses.Medicines will be given orally.Each case will be followed up at regular interval as per requirement.Each patient will be studied for 6 months after enrollment in study.Outcome assessement of the patients will be carried out after 6 months of homoeopathic medication based on Self assessment score for insomnia recorded at baseline and at the 6th months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Suffering from insomnia at least 3 months.
b. Patients of both sexes.
c. Different religion and socioeconomic status.
d. Age-18-60years age group,
e. Patients who can read/write /understand either English, Hindi or Bengali languages.
f. Patients willing to take part in the study and ready to give informed consent for the same.
|
|
| ExclusionCriteria |
| Details |
a. Patients who are too sick for consultation
b. Patient not willing to take part in the study and not ready to give written consent for the same.
c. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure
d. Lactating or Pregnant Women.
e. Undergoing Homoeopathic treatment for any chronic disease from other physician.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Self Assessment Score for Insomnia |
At baseline & at 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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)
|
04/08/2023 |
| 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 - NO
|
|
Brief Summary
|
Insomnia is the disturbance in the sleep .Patient may experienced with delayed sleep, difficulty in remaining asleep or early rising with unrefreshed feeling. According to ICD-10-CM codes the diagnostic code G47.0 is used for insomnia. Self assessment score for insomnia is using for the outcome assessment .Kent"s Repertory contains a lots of rubrics related Insomnia .Conducting a prospective clinical study using general Repertory like kent"s Repertory will help in verifying the homoeopathic principles and enriching the study of our Materia Medica. |