| CTRI Number |
CTRI/2022/09/045692 [Registered on: 20/09/2022] Trial Registered Prospectively |
| Last Modified On: |
13/09/2022 |
| 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 in Primary Insomnia |
|
Scientific Title of Study
|
A clinical study on the efficacy of homoeopathic medicines in the treatment of Primary Insomnia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prajakta Udmale |
| Designation |
Assistant Professor |
| Affiliation |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673489910 |
| Fax |
|
| Email |
prajakta.udmale@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tilottama Galande |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822508664 |
| Fax |
|
| Email |
tilottama.galande@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajakta Udmale |
| Designation |
Assistant Professor |
| Affiliation |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673489910 |
| Fax |
|
| Email |
prajakta.udmale@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Udmale |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, 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 Prajakta Udmale |
Dr. D.Y.Patil Homoeopathic Medical College and Research Centre |
1st floor, OPD and IPD of Dr.D.Y.Patil Homoeopathic Medical College, Pimpri
Pune
MAHARASHTRA |
9673489910
prajakta.udmale@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, pImpri, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines with the stimulus control therapy and sleep restriction therapy. |
Constitutional Homoeopathic Medicine by oral route of administration alongwith the stimulus control therapy and sleep restriction therapy after every 15 days for 1 month. |
| Comparator Agent |
Placebo with the stimulus control therapy and sleep restriction therapy. |
Placebo dose by oral route of administration alongwith stimulus control therapy and sleep restriction therapy every 15 days for 1 month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both the sex and between the age group of 20 years to 45 years and suffering from primary insomnia |
|
| ExclusionCriteria |
| Details |
Patients suffering from other systemic illnesses, hypothyroidism and hyperthyroidism and on any medication, Patients who have undergone any surgery within the past 6 months, Patient on the course of narcolepsy, or suffering from breathing-related sleep disorder, sleep apnea, circadian rhythm sleep disorder or parasomnia, Patient suffering from any another mental disorder such as major depressive disorder, generalized anxiety disorder, a delirium, neurological disorders, Patient suffering from insomnia due to the direct physiological effects of a substance, on alcoholism, tobacco addiction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of homoeopathic medicines in the treatment of primary insomnia |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To clinically evaluate the efficacy of homoeopathic medicines in the treatment of primary insomnia |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
24/09/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 medicines in the treatment of primary insomnia. Group 1: The indicated homoeopathic medicine will be administered with the stimulus control therapy and sleep restriction therapy. Group 2: Placebo with the stimulus control therapy and sleep restriction therapy will be administered to this group. Study Duration 1 month with follow up at every 15th and last on 30th day |