| CTRI Number |
CTRI/2024/11/076634 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study is to compare how efficiently the two medications, Duloxetine and Gabapentin separately prevent or retard the progression of peripheral nerve damage which is caused by long standing uncontrolled diabetes disease in the patients presenting in the medicine OPD of a tertiary care hospital. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON EFFICACY AND SAFETY OF DULOXETINE AND GABAPENTIN AMONG PATIENTS WITH DIABETIC POLYNEUROPATHY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilam Nigam |
| Designation |
Professor |
| Affiliation |
Rama Medical College Hospital and Research Centre, Kanpur |
| Address |
Department of Pharmacology and Therapeutics, Rama Medical College, Mandhana, Kanpur, Uttar Pradesh, India-209217
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
9140190479 |
| Fax |
|
| Email |
drnilamnigam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilam Nigam |
| Designation |
Professor |
| Affiliation |
Rama Medical College Hospital and Research Centre, Kanpur |
| Address |
Department of Pharmacology and Therapeutics, Rama Medical College, Mandhana, Kanpur, Uttar Pradesh, India-209217
UTTAR PRADESH
209217
India |
| Phone |
9140190479 |
| Fax |
|
| Email |
drnilamnigam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruquaiya Khatoon |
| Designation |
Junior Resident |
| Affiliation |
Rama Medical College Hospital and research Centre, kanpur |
| Address |
Department of Pharmacology and Therapeutics, Rama Medical College, Mandhana, Kanpur, Uttar Pradesh, India-209217
132/325 Babu Purwa, Kanpur, Uttar Pradesh, India-208023
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
7007234362 |
| Fax |
|
| Email |
ruquaiyakhatoon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural Suppoert by Rama Medical College Hospital and Research centre
Department of Pharmacology and Therapeutics and Department of Medicine, Rama Medical college Hospital and Research centre, Mandhana, Kanpur, Uttar Pradesh, India-209217 |
|
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Primary Sponsor
|
| Name |
Rama Medical College Hospital and research centre |
| Address |
Mandhana, Kanpur, Uttar Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nilam Nigam |
Rama medical college hospital and research centre |
Department of Pharmacology and therapeutics, second floor, room no 02158, Medical college building, RMCH&RC, Mandhana, Kanpur-209217
Kanpur Nagar
UTTAR PRADESH |
914090479
drnilamnigam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Rama Medical College Hospital And research centre |
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: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
duloxetine - Serotonin and noradrenaline reuptake inhibitors SNRI |
Tab Duloxetine 60mg one tab od
administered to group I daily for 12 weeks |
| Comparator Agent |
Gabapentine - Cyclic GABA analogue |
tab Gabapentin 300mg one tab od administered to group II for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient of both the sexes 20-70 years of age, having Diabetes mellitus type 2 having diabetic polyneuropathy pain attending medicine OPD will be included in our study.
Cooperative and conscious patient.
Patient who will give written and informed consent and and are willing to go for follow up.
Patient not taking any previous medication for diabetic neuropathy.
Patient willing to undergo all pre and post treatment, investigation and willing to complete the prescribed course of treatment. |
|
| ExclusionCriteria |
| Details |
Patients having Diabetes mellitus type 2 and is diagnosed with other types of neuropathy and disorders & B12 deficiency will be excluded from the study.
Patients who are already on medication for diabetic polyneuropathy.
Patients with renal impairment, hepatic impairment and cardiac disease will be excluded from the study.
Patients on drugs which increases the blood sugar level eg. steroids, adrenaline.
Patients who are planning to conceive will be excluded.
Pregnant and lactating women will be excluded.
Mentally retarded and with altered state of mind will be excluded.
Immunocompromised and drug abuse.
Patients of Hepatic impairment.
Patients having history of hypersensitivity to any of study drugs. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
VAS score
Physical Examination
Biochemical Examination |
Day 0, 4th week, 8th week, 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
Day 0, 4th week, 8th week, 12th week |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study of comparison of safety and efficacy of DULOXETINE and GABAPENTIN among patients with diabetic polyneuropathy at Rama Medical College Hospital & Research Centre, Kanpur.
In 2019, diabetes affected 9.3% of individuals aged 20–79 globally, with prevalence ranging from 4.7–12.2%. The countries with the highest diabetic populations were China (116.4 million), India (77 million), the United States (31 million), Pakistan (19.4 million), Brazil (16.8 million), and Mexico (12.8 million).
Diabetic peripheral neuropathy is identified by symptoms and signs of peripheral nerve damage in diabetes patients, excluding other potential causes. It ranks among the most common long-term complications of diabetes, impacting approximately 60% of diabetic individuals.
It stands as the primary cause of lower leg amputation in both the USA (50–75%) and India (76–78%) among amputations linked to diabetes or neuropathy. Neurological complications are equally prevalent in both Type 1 and Type 2 diabetes mellitus patients. Neuropathic pain is reported in 11–32% of individuals experiencing polyneuropathy.
Symptomatic relief for diabetic neuropathy, not effectively managed through glycemic control, involves using drugs such as amitriptyline, duloxetine, gabapentin, or pregabalin. According to National Institute for Health and Clinical Excellence guidelines, the choice among these drugs is based on assessing the risk and benefit for each patient. If there’s inadequate response or severe side effects with one drug, the treatment may be shifted to an alternative from the listed options.
Duloxetine and gabapentin, both FDA-approved oral agents, are typically the initial choices for addressing pain linked to diabetic neuropathy in the United States.
OBJECTIVES - To monitor the adverse drug reactions for safety profile of the drugs.
- To monitor the efficacy of Duloxetine and Gabapentin.
- Comparison of compliance in patients treated with DULOXETINE and GABAPENTIN.
Materials and methods:
Place of Study: Department of Pharmacology with Department of Internal Medicine at Rama Medical College Hospital & Research Centre, Kanpur, UP. Type of study: The study will be observational, comparative, computer randomized, open labelled parallel group study. Study Duration: Research study will be 1 year(April 2024-March 2025). Sample size: 150 patients of Type 2 diabetes mellitus with diabetic neuropathic pain
All the patients diagnosed with diabetic polyneuropathy pain attending outpatient department of Internal Medicine, fulfilling inclusion criteria and willing to give written informed consent will be included in the study. An appropriate number of patients will be enrolled and will be divided into two groups via computer generated, ramdomized method. - Group I - will be administered Duloxetine 60mg OD for 12 weeks
- Group II - will be administered Gabapentin 300mg OD for 12 weeks
Patients unable to continue the prescribed treatment protocol will be cancelled to continue the treatment. Failure to which will be excluded from the study. Patients will be assessed with the relief of symptoms at the interval through Visual Analogue Scale of 0-10 and other clinical evaluation at every 4 weeks interval at 0, 4, 8 and 12 weeks respectively.
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