| CTRI Number |
CTRI/2017/08/009577 [Registered on: 31/08/2017] Trial Registered Prospectively |
| Last Modified On: |
23/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Epalrestat and Benfotiamine in Reducing Nerve Damage in Patients with Diabetes Mellitus (Type 2 Diabetes) |
|
Scientific Title of Study
|
Efficacy of Epalrestat and Benfotiamine in Patients with Diabetic Neuropathy. A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Priyadarsini |
| Designation |
Junior Resident (Postgraduate) |
| Affiliation |
JIPMER |
| Address |
Department of Pharmacology,
Institute Block, III Floor, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9790820215 |
| Fax |
|
| Email |
priya3491@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Manikandan |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Pharmacology,
Institute Block, III Floor, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443774648 |
| Fax |
|
| Email |
drsmanikandan001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeswari Aghoram |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Neurology, SSB, II Floor, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9790209240 |
| Fax |
|
| Email |
rajeswari.a@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund, Admin Block, 1st Floor, JIPMER Campus, Dhanvantri Nagar, Puducherry - 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER Intramural fund |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvanthri Nagar, Puducherry-605006 |
| 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 B Priyadarsini |
JIPMER hospital |
Department of Pharmacology, Institute Block (Third Floor), JIPMER campus, Dhanvantri Nagar
Pondicherry
PONDICHERRY |
9790820215
priya3491@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee (Human studies) JIPMER, Reg.n o.ECR/687/Jipmer/Inst/ PY/2013 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic Neuropathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Benfotiamine |
Benfotiamine 100mg three times a day for 3 months in addition to standard background therapy |
| Intervention |
Epalrestat |
Epalrestat 50mg three times a day for 3 months in addition to standard background therapy |
| Comparator Agent |
NIL |
Not Applicaple |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with type 2 diabetes mellitus presenting to the
diabetology clinic of Medicine outpatient department (OPD) diagnosed to have diabetic neuropathy with symptoms of paresthesia,
dysesthesia, numbness, hypoesthesia (but not anesthesia). |
|
| ExclusionCriteria |
| Details |
1. Patients with peripheral vascular diseases
2. Patients taking Vitamin B12, Vitamin B6, alpha lipoic acid, gabapentin,
pregabalin, duloxetine and amitryptiline.
3. Patients with renal and hepatic dysfunction and congestive cardiac failure
4. Patients without reasonably good levels of HbA1c(>8.5) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Sensory nerve conduction velocity in median and sural nerves
2. Motor nerve conduction velocity in median and common peroneal nerves |
1.Baseline, 3rd month end
2.Baseline, 3rd month end |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Sensory Nerve Action Potential (SNAP) - Median and Sural nerves
2. F Wave Latency (FWL) - Median and Common Peroneal nerves
3. Compound Muscle Action Potential (CMAP) - Median and Common Peroneal
nerves
4. Distal Motor Latency- Median and Common Peroneal Nerves
5. Vibration Perception Threshold- Median, Common Peroneal and Sural nerves
6. Diabetic Neuropathy Symptom Score (DNS)
7. Toronto Clinical Scoring System (TCSS)
8. Adverse Effect Profile |
1. Baseline, at the end of 3rd month
2. Baseline, at the end of 3rd month
3. Baseline, at the end of 3rd month
4. Baseline, at the end of 3rd month
5. Baseline, at the end of 3rd month
6. Baseline, at the end of 3rd month
7. Baseline, at the end of 3rd month
8. 1st, 2nd and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
22/09/2017 |
| 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="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetic neuropathy is one of the most common complications of diabetes and causes maximum morbidity to the patients. The prevalence of diabetic neuropathy varies between 10-90%. The risk increases with duration of diabetes. There is a huge economic burden which is caused both to the patients and the health care sector due to irreversible diabetic neuropathy. Hence early diagnosis and management is imperative in the improvement of quality of life of the patients failing which serious consequences including disability and amputation can occur.The current treatment of diabetic neuropathy is purely symptomatic and does not stop the progression of the disease. Hence research has been undertaken in the development of disease modifying agents. Epalrestat which is an aldose reductase inhibitor can inhibit the polyol pathway and benfotiamine which is a thiamine analog can inhibit the formation of advanced glycation end products and combat oxidative stress. These drugs may be used as disease modifying agents in the treatment of diabetic neuropathy if given at an early stage, before irreversible damage sets in. Studies have shown the beneficial effect of these drugs in diabetic neuropathy. But the superiority of one over the other is not yet investigated. The results of this trial may establish the superiority of one of the drug over the other in the treatment of diabetic neuropathy. If the treatment is initiated at an early stage it can reverse the pathology, reduce the morbidity caused due to diabetic neuropathy and improve the quality of life in these patients.
Research Question:
Is three months of therapy with epalrestat more efficacious than benfotiamine in the treatment of diabetic neuropathy in patients with type 2 diabetes mellitus?
Research Hypothesis:
Three months of therapy with epalrestat is more efficacious than benfotiamine in the treatment of diabetic neuropathy in patients with type 2 diabetes mellitus.
|