| CTRI Number |
CTRI/2020/03/023789 [Registered on: 05/03/2020] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Prescriber Based, Active Post Marketing Surveillance Study (PMS) to Generate The Safety & Efficacy Data Of Diazepam and Propranolol in The Treatment of Chronic Anxiety & Insomnia in Actual Field Conditions Of Use. |
|
Scientific Title of Study
|
Prescriber Based, Active Post Marketing Surveillance Study (PMS) to Generate The
Safety & Efficacy Data Of Diazepam and Propranolol in The Treatment of Chronic Anxiety & Insomnia
in Actual Field Conditions Of Use. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nimesh Patel |
| Designation |
M.D. General Medicine |
| Affiliation |
Sanjeevani Heart & Medical Hosptial |
| Address |
Sanjeevani Complex,near Devasya Clinic, Opposite Mehsana Society, Vadaj road
Ahmadabad
GUJARAT
380013
India |
| Phone |
27641742 |
| Fax |
|
| Email |
dr_nimesh_patel@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimesh Patel |
| Designation |
M.D. General Medicine |
| Affiliation |
Sanjeevani Heart & Medical Hosptial |
| Address |
Sanjeevani Complex,near Devasya Clinic, Opposite Mehsana Society, Vadaj road
Ahmadabad
GUJARAT
380013
India |
| Phone |
27641742 |
| Fax |
|
| Email |
dr_nimesh_patel@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimesh Patel |
| Designation |
M.D. General Medicine |
| Affiliation |
Sanjeevani Heart & Medical Hosptial |
| Address |
Sanjeevani Complex,near Devasya Clinic, Opposite Mehsana Society, Vadaj road
Ahmadabad
GUJARAT
380013
India |
| Phone |
27641742 |
| Fax |
|
| Email |
dr_nimesh_patel@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| AN Pharmacia Laboratories Pvt ltd |
|
|
Primary Sponsor
|
| Name |
AN Pharmacia Laboratories Pvt ltd |
| Address |
21-23, Industrial Area, Mehatpur, dist – Una, Himachal Pradesh |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Nimesh Patel |
Sanjeevani Heart and Medical Hospital |
Sanjeevani complex, Opposite Mehsana Society, Nava Vadaj Road, Ahmedabad
Ahmadabad
GUJARAT |
7927641742
dr_nimesh_patel@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committee |
Approved |
| Ethics committe Sanjeevani Hospital |
Approved |
| Institutional Ethics Committee, NIMS University Rajasthan, Jaipur |
Approved |
| Shri Durgamba Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Diazepam and Propranolol |
Treatment of Chronic anxiety & Insomnia
Frequency: Twice a day
Dose: Combination of Diazepam 2.5mg and Propanol Hydrochloride 20mg
Route of administration: Oral |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Both Male and Female patient.
2. Ages: > 18 years and < 65 years.
3. Patients with Chronic Anxiety and Insomnia.
4. Confirmed diagnosis of primary insomnia (as defined by
the Diagnostic and Statistical Manual for Mental
Disorders-IV [DSM-IV-TR]) present at the time of
evaluation for at least 3 months
5. Baseline Hamilton Rating Scale for Anxiety (HAMA)
scores ≥18
6. Patient with history of primary insomnia
7. Women of child bearing age willing to take contraceptive
measure to prevent pregnancy during the study
8. Patients willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to the study drugs
2. Chronic heart failure, respiratory failure or chronic liver and renal failure.
3. Patient with active cancer
4. Female who is pregnant, planning a pregnancy (during the course of the study) or nursing a child
5. Certain medications that may interfere with the study medication and worsen the patient condition (these will be identified by the study Investigator).
6. Patients with a history of chronic hepatitis B or C infection, HIV infection.
7. Clinically significant disorder that may unsuitable for study participation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment based on HAMA scale, Clinician Global Impression (CGI) and Patient Global Impression (PGI) scales |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate efficacy of this FDC in treatment of Chronic Anxiety and Insomnia. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
09/03/2020 |
| Date of Study Completion (India) |
03/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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)?
|
|
Brief Summary
|
Prescriber Based, Active Post Marketing Surveillance Study (PMS) to Generate The Safety & Efficacy Data Of Diazepam and Propranolol in The Treatment of Chronic Anxiety & Insomnia in Actual Field Conditions Of Use.
The secondary
objective of this PMS trial is to find out efficacy of the product by clinician
global assessment. |