| CTRI Number |
CTRI/2023/04/051877 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Anxiety Related Insomnia and Homeopathy |
|
Scientific Title of Study
|
Study on anxiety Related Insomnia and their Homoeopathic Management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilay |
| Designation |
Assistant Professor |
| Affiliation |
RBTS, Govt. Homeopathic Medical College & Hospital |
| Address |
O.P.D.no 1,5 and 6 and I.P.D. of RBTS, Govt. Homeopathic Medical College and Hospital, Ramdayalu Nagar , Muzaffarpur, Bihar
Department of Materia Medica and Practice of medicine
Muzaffarpur
BIHAR
842002
India |
| Phone |
9135066687 |
| Fax |
|
| Email |
dr.nilay76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilay |
| Designation |
Assistant Professor |
| Affiliation |
RBTS, Govt. Homeopathic Medical College & Hospital |
| Address |
OPD no 1,5 and 6 and IPD of RBTS, Govt. Homeopathic Medical College and Hospital, Ramdayalu Nagar , Muzaffarpur, Bihar
Department of Materia Medica and Practice of Medicine
Muzaffarpur
BIHAR
842002
India |
| Phone |
9135066687 |
| Fax |
|
| Email |
dr.nilay76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilay |
| Designation |
Assistant Professor |
| Affiliation |
RBTS, Govt. Homeopathic Medical College & Hospital |
| Address |
OPD no 1,5 and 6 and IPD of RBTS, Govt. Homeopathic Medical College and Hospital, Ramdayalu Nagar , Muzaffarpur, Bihar
Department of Materia Medica and Practice of Medicine
Muzaffarpur
BIHAR
842002
India |
| Phone |
9135066687 |
| Fax |
|
| Email |
dr.nilay76@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Government Homoeopathic Medical college and Hospital,ramdayalunagar,Muzaffarpur,Bihar,Pin-842002 |
|
|
Primary Sponsor
|
| Name |
DrNilay |
| Address |
RBTS Government Homoeopathic Medical College and Hospital,Ramdayalunagar,Muzaffarpur,Bihar |
| 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 Nilay |
RBTS Government Homoeopathic Medical College and Hospital |
OPD no 1 ,5and 6 and IPD of RBTS govt hom.mefical college and hospital ramdayalunagar,Muzaffarpur
Muzaffarpur
BIHAR |
9135066687
dr.nilay76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RBTS Govt.Hom.Med.College and Hospital Muzaffarpur,Bihar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F519||Sleep disorder not due to a substance or known physiological condition, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Drugs |
Homoeopathic drugs as detailed in the pharmacopeia will be used in the study on the basis of symptoms similarity. The medicine used for trial shall be procured from a GMP certified company.medicine will dispensed in globules of standard size 30 and they will be adminstered in single dose in sac lac followed by Placebo until the end of follow up with maximum ofthree months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having insomnia for last 3 month
2. Patient age between 15-50 years
3. Both sexes
|
|
| ExclusionCriteria |
| Details |
1. Insomnia less than 3 month
2. Patient suffering from severe illness or co-morbidity
3. Patient unwilling to take part or not giving the consent for study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome: the response of the treatment of the patient suffering from insomnia. All outcome will be assessed by changes in the symptoms of insomnia. At base line and after 3 month
|
10 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| What are the other factors responsible for Insomnia |
10 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/04/2023 |
| Date of Study Completion (India) |
27/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to assess the effectiveness of Homoeopathic remedy in anxiety related insomnia.It is prospective,single blind,one arm clinical trial.Total duration of study is 10 months.The study will be conducted in O.P.D. and I.P.D. of R.B.T.S. Government Homoeopathic Medical College and Hospital.Study population includes patients having insomnia for last 3 months,age group 15-50 years,both sexes,it excludes patients with comorbidity,who are unable to take Homoeopathic medicines. |