| CTRI Number |
CTRI/2020/03/024235 [Registered on: 25/03/2020] Trial Registered Prospectively |
| Last Modified On: |
17/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effect of tablet pregabalin and tablet duloxetine with tablet pregabalin and tablet nortriptyline in neuropathic pain after herpes and changes in HLA-A33 and HLA-B44 GENES. |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE STUDY EVALUATING
THE EFFICACY OF PREGABALIN AND DULOXETINE
Versus PREGABALIN AND NORTRIPTYLINE AND THE
MODULATION OF mRNA EXPRESSION OF HLA-A33 AND
HLA-B44 GENES IN PATIENTS OF POST-HERPETIC NEURALGIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Kumar |
| Designation |
Professor,Head of Department, |
| Affiliation |
University College Of Medical Sciences and GTB Hospital |
| Address |
Department Of Anaesthesiology and Critical Care,Second Floor,GTB Hospital,University College of Medical Sciences,Dilshad Garden,New Delhi
Department Of Anaesthesiology and Critical Care,Second Floor,GTB Hospital,University College of Medical Sciences,Dilshad Garden,New Delhi
East
DELHI
110095
India |
| Phone |
9810431367 |
| Fax |
|
| Email |
profashoksaxena2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Professor,Head of Department, |
| Affiliation |
University College Of Medical Sciences and GTB Hospital |
| Address |
Department Of Anaesthesiology and Critical Care,Second Floor,GTB Hospital,University College of Medical Sciences,Dilshad Garden,New Delhi
Department Of Anaesthesiology and Critical Care,Second Floor,GTB Hospital,University College of Medical Sciences,Dilshad Garden,New Delhi
East
DELHI
110095
India |
| Phone |
9810431367 |
| Fax |
|
| Email |
profashoksaxena2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna Vasudev |
| Designation |
Post Graduate student |
| Affiliation |
University College Of Medical Sciences and GTB Hospital |
| Address |
Department Of Anaesthesiology and Critical Care,Second Floor,GTB Hospital,University College of Medical Sciences,Dilshad Garden,New Delhi
Department Of Anaesthesiology and Critical Care,Second Floor,GTB Hospital,University College of Medical Sciences,Dilshad Garden,New Delhi
East
DELHI
110095
India |
| Phone |
9717819078 |
| Fax |
|
| Email |
vasudevprerna2@gmail.com |
|
|
Source of Monetary or Material Support
|
| University college of medical sciences and GTB Hospital,Dilshad Garden,New Delhi-110095 |
|
|
Primary Sponsor
|
| Name |
University College Of Medical Sciences |
| Address |
University College of Medical Sciences,Dilshad Garden,New Delhi |
| 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 |
| Dr Prerna Vasudev |
University College of Medical Sciences and GTB Hospital |
Department of anaesthesiology and critical care,second floor,university college of medical sciences and GTB hospital,Dilshad garden,new delhi
East
DELHI |
9717819078
vasudevprerna2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Tablet Pregabalin and Tablet Duloxetine in comparison with tablet Pregabalin and tablet Nortriptyline in patients of post herpetic neuralgia. |
Tablet Pregabalin 75mg BD and Tablet Duloxetine 20mg BD in comparison with Tablet Pregabalin 75 mg BD and tablet Nortriptyline 10mg BD in patients of post herpetic neuralgia. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients should have a diagnosis of PHN with evident hyperalgesia and allodynia.
2. Patients of PHN should have pain for at least 12 weeks after the healing of rash.
3.Pain intensity ≥ 4 on 10 of NRS-pain scale |
|
| ExclusionCriteria |
| Details |
1.Patients with history of neurological intervention for PHN.
2.Evidence of other sources of chronic or acute pain that may confound the diagnosis
3. Known history of intake Pregabalin or Duloxetine for PHN in past 4 weeks.
4. Patients with past h/o MI, DM, pancreatitis and vasculitis.
5. Patients with evidence of renal impairment/history of alcohol consumption and smoking.
6.Patients with psychiatric or substance abuse disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients achieving NRS-pain score of 4/10 at the end of 12th week in both
the groups.
2. The neuropathic component of pain using NPSI score in both the groups. |
At baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. NRS-sleep score in the two groups at various designated intervals.
2. PDQ score in both the groups at various designated intervals.
3. The quality of life (QoL) using SF-12 score in the two groups at various designated
intervals.
4. Modulation in mRNA expressions of HLA-A33 and HLA-B44 genes at baseline and after
12 weeks of treatment. |
At baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| 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)?
|
|
Brief Summary
|
The present randomized comparative study evaluating the efficacy of pregabalin and duloxetine versus Pregabalin and Nortriptyline and the modulation of mRNA expression of HLA-A33 and HLA-B44 genes in the management of post-herpetic neuralgia.Patients with diagnosis of PHN with evident hyperalgesia and allodynia or patients of PHN having pain for at least 12 weeks after the healing of rash or Pain intensity ≥ 4 on 10 of NRS-pain scale will be included.Patients will be excluded if there is history of neurological intervention for PHN or evidence of other sources of chronic or acute pain that may confound the diagnosis or Known history of intake Pregabalin or Duloxetine for PHN in past 4 weeks or past h/o MI, DM, pancreatitis and vasculitis or any evidence of renal impairment/history of alcohol consumption and smoking or psychiatric or substance abuse disorder.Patients suffering from PHN will be divided into two groups of twenty-five patients each by random allocation. One group will receive combination of Pregabalin plus Duloxetine and other group Pregabalin and Nortriptyline. Assessment of pain will be done at baseline and at the end of 1st week,2nd week,4th week,8th week and 12th week.The sample size for the study will be 25 patients in each group.Primary outcome measure is NRS-pain score. Secondary outcome measures are NPSI, NRS-sleep score,PDQ score ,quality of life (QoL) using SF-12 score. Modulation in mRNA expressions of HLA-A33 and HLA-B44 genes at baseline and after 12 weeks of treatment. |