| CTRI Number |
CTRI/2023/01/049340 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Of Constitutional
Homoeopathic Medicines In Stress Induced Insomnia |
|
Scientific Title of Study
|
A Clinical Study Of The Role Of Constitutional Prescribing In Cases Of Stress Induced Insomnia In The Age Group Of 20-40 Years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruti Deepak Dube |
| Designation |
PG Scholar |
| Affiliation |
B.V.D.U. Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept of Post Graduate And Research Centre, Dept of Organon, Third floor, Pune-Banglore Highway, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9822075079 |
| Fax |
|
| Email |
shrutid489@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Babar |
| Designation |
MD (HOM) Assistant Professor Of Organon Of Medicine And Homoeopathic Philosophy |
| Affiliation |
B.V.D.U. Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept of Post Graduate And Research Centre, Dept of Organon, Third floor, Pune-Banglore Highway, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
7738140654 |
| Fax |
|
| Email |
anuradha.babar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Deepak Dube |
| Designation |
PG Scholar |
| Affiliation |
B.V.D.U. Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept of Post Graduate And Research Centre, Dept of Organon, Third floor, Pune-Banglore Highway, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9822075079 |
| Fax |
|
| Email |
shrutid489@yahoo.com |
|
|
Source of Monetary or Material Support
|
| B.V.D.U. Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre |
|
|
Primary Sponsor
|
| Name |
DR SHRUTI DEEPAK DUBE |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital, Dept of Post Graduate And Research Centre, Pune-Banglore Highway, Pune. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Shruti Deepak Dube |
BVDUHMC, Dept of Post Graduate and Research Centre, Dept of Organon of medicine and Philosophy |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital, Dept of Post Graduate And Research Centre, Pune-Banglore Highway, Pune- 411043
Pune
MAHARASHTRA |
9822075079
shrutid489@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Vidyapeeth (DTU) HMC, Pune |
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 |
Constitutional Homoeopathic Medicine |
Constitutional Homoeopathic Medicine will be administered in the form of globules and powder through oral route. Further doses will be administered according to the requirement of the patient.
Dose - Dose will depend on the susceptibility of patient.
Frequency - It will be decided according to requirement of the patient.
Route of Administration - Oral route.
Duration of Therapy - 3 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
(1) Subjects Should fulfil the diagnostic criteria by DSM-V. (2) Subjects within the range of age group of 20-40 years of both sexes. (3) Subjects fulfilling assessment of stress. |
|
| ExclusionCriteria |
| Details |
1.Subjects having Drug induced insomnia and insomnia due to other Neurological causes.
2.Subjects taking conventional treatment for insomnia.
3.Pregnant women and lactating mothers will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of homoeopathic constitutional medicines in cases of stress induced insomnia in the age group of 20-40 years. |
Score of the Insomnia Severity Index (ISI) will be calculated at the time of enrollment and at the end of 5 follow ups. The score of SATED Questionnaire will be calculated at the time of enrollment of patient and at every 15 days of follow ups for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the efficacy of homoeopathic constitutional medicine in relief of Stress induced Insomnia.
2.To improve the sleep quality in terms of duration, episodes of awakening in middle of the night, efficiency and satisfaction.
3.To improve general quality of life by reducing sleepiness during the day and increasing working abilities.
|
Score of the Insomnia Severity Index (ISI) will be calculated at the time of enrollment and at the end of 5 follow ups. The score of SATED Questionnaire will be calculated at the time of enrollment of patient and at every 15 days of follow ups for 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2023 |
| Date of Study Completion (India) |
11/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To study the efficacy of homoeopathic constitutional medicines in cases of stress induced insomnia in the age group of 20-40 years. The study will be done on 30 patients at BVDUHMC, Pune. The patients will be followed up after every 15 days and will be asked questions from SATED Questionnaire to assess sleep health. Outcome assessment will be done based on the data collected from the score of the Insomnia Severity Index (ISI) and the score of SATED Questionnaire before and after giving Homoeopathic constitutional medicine.
|