| CTRI Number |
CTRI/2021/02/031068 [Registered on: 08/02/2021] Trial Registered Prospectively |
| Last Modified On: |
06/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing the benefit of tablet PREGABALIN with tablet DULOXETINE and only tablet PREGABALIN in nerve pain in diabetes and relation with PPARG and Akt gene |
|
Scientific Title of Study
|
A Randamized double-blind comparative study evaluating the efficacy of a combination of PREGABALIN and DULOXETINE versus PREGABALIN alone and the modulation of mRNA expression of PPARG and Akt genes in patients of painful Diabetic peripheral neuropathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIMISHA T |
| Designation |
POST GRADUATE STUDENT 1st YEAR |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL |
| Address |
Department of anaesthesia and critical care
second floor
university college of medical sciences and GTB hospital
dilshad garden delhi
East
DELHI
110095
India |
| Phone |
8281343461 |
| Fax |
|
| Email |
nimisha2292@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHOK KUMAR |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL |
| Address |
Department of anaesthesia and critical care
second floor
university college of medical sciences and GTB hospital
dilshad garden delhi
East
DELHI
110095
India |
| Phone |
9810431367 |
| Fax |
|
| Email |
profashoksaxena2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NIMISHA T |
| Designation |
POST GRADUATE STUDENT 1st YEAR |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL |
| Address |
Department of anaesthesia and critical care
second floor
university college of medical sciences and GTB hospital
dilshad garden delhi
East
DELHI
110095
India |
| Phone |
8281343461 |
| Fax |
|
| Email |
nimisha2292@gmail.com |
|
|
Source of Monetary or Material Support
|
| UNIVERSITY COLLEGE OF MEDICAL SCIENCES,GATE NO 2, TAHIRPUR ROAD, GTB ENCLAVE, DILSHAD GARDEN,110095 |
|
|
Primary Sponsor
|
| Name |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES |
| Address |
Department of anaesthesia and critical care
second floor
university college of medical sciences and GTB hospital
dilshad garden 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 |
| NIMISHA T |
University college of medical sciences and GTB Hospital |
Department of Anaesthesiology and Critical care,2nd floor,University college of medical science and GTB Hospital ,Dilshad garden,110095,delhi
East
DELHI |
8281343461
nimisha2292@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee- Human Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E134||Other specified diabetes mellituswith neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of Tablet PREGABALIN 75 mg and Tablet DULOXETINE 30 mg |
Combination of Tablet PREGABALIN 75 mg and Tablet DULOXETINE 30 mg from the start of recruitment of patients till 12 weeks |
| Comparator Agent |
Tablet PREGABALIN 75 MG, |
Tablet PREGABALIN 75MG twice a day orally, from the start of recruitment of patients till 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patients’ ≥ 18 years of age with pain due to diabetic peripheral neuropathy
caused by type -I or II Diabetes mellitus for at least 3 months with confirmed diagnosis
on Michigan Neuropathy Screening instrument with score ≥3 at the time of screening.
2.Patients must have average pain severity of ≥ 4/10 on NRS.
3. Brief Pain Inventory- Modified short form (BPI- MSF) ≥ 4.
4.Patients should have stable glycemic control with HbA1C < 12%. |
|
| ExclusionCriteria |
| Details |
1.Patients who had received duloxetine or pregabalin in the past except for less than 15
days course.
2. Evidence of other sources of pain that may confound the diagnosis or recent history of
surgery.
3.Patients with past history of MI, liver disease, pancreatitis and vasculitis, heart failure,
seizure, & arrhythmia.
4. Patients with evidence of renal impairment, diabetic foot ulcer/gangrene of the foot &
history of alcohol consumption and smoking. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
1)Proportion of patients achieving NRS Pain score of ≤ 3/10 at the end of 12th week in both
the groups
2)The neuropathic component of pain using NPSI scores between the two groups |
Baseline, 2nd, 4th and 8th and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NRS-Sleep score,
BPI-MSF score,
PDQ score,
SF-12 score
Modulation of mRNA expression of PPARG and Akt gene at baseline and at the end of 12th week |
Baseline, 2nd, 4th and 8th and 12th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2021 |
| 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
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a prospective double blind randomized compararive trial evaluating the efficacy of a combination of pregabalin and duloxetine versus pregabalin alone and the modulation of mRNA expression of PPARG and Akt genes in patients of diabetic peripheral neuropathy and primary objective is to assess the Numerical Rating Scale (NRS) and Neuropathic Pain Symptom Inventory (NPSI) scores in both the groups at baseline 2nd ,4th,8th and 12th week.Patients with established diagnosis of DPN will be referred from Department of Endocrinology to the pain relief clinic under the Department of Anesthesiology. Patients having a diagnosis of DPN with pain intensity ≥ 4/10 on Numerical Rating Scale for pain (NRS-pain) will be taken up for the study. Following diagnosis of DPN, baseline assessments will be made for pain and quality of life. Two ml venous blood samples will be collected and in total two samples will be extracted and mRNA expression of PPARG and Akt genes will be performed at base line and at 12 weeks of treatment by using Real Time Quantitative PCR. Patients suffering from DPN will be divided into two groups of thirty patients each by random allocation. One group will receive combination of Pregabalin plus Duloxetine and other group will receive Pregabalin monotherapy. Primary outcomes of the trial are to assess the proportion of patients achieving NRS-pain score of ≤ 3/10 following drug therapy i.e. at the end of 12th week in both the groups and neuropathic component of pain using NPSI score in both the groups. Secondary outcome measures the NRS- Sleep score in the 2 groups at various designated intervals, BPI-MSF score in both the groups at various designated intervals, PDQ score in both the groups at various designated intervals, Quality of life using SF-12 score in 2 groups at various designated intervals and modulation in mRNA expressions of genes PPARG & Akt at baseline and after 12 weeks of treatment.
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