| CTRI Number |
CTRI/2025/10/096585 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study about safety, effectiveness and improvement in quality of life achieved by duloxetine and desvenlafaxine in adult patients of diabetic peripheral neuropathy |
|
Scientific Title of Study
|
A comparative study of safety, efficacy and quality of life outcomes of duloxetine with desvenlafaxine in adult patients of diabetic peripheral neuropathy : A Randomized Controlled Academic Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prarthana Deori |
| Designation |
Post-Graduation Trainee, MD Pharmacology |
| Affiliation |
Dr. Rajendra Prasad Government Medical College, Kangra at Tanda |
| Address |
Room 816, Department of Pharmacology
Dr. Rajendra Prasad Government Medical College, Tanda
Dist Kangra, H.P.
Dr. RPGMC, Tanda
Kangra, Himachal Pradesh
HIMACHAL PRADESH
176001
India |
| Phone |
7577971625 |
| Fax |
|
| Email |
deoriprarthana30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atal Sood |
| Designation |
Professor & Head of Department |
| Affiliation |
Dr. Rajendra Prasad Govt. Medical College, Kangra at Tanda |
| Address |
Dr. Rajendra Prasad Government Medical College, Tanda
Dist. Kangra, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418063191 |
| Fax |
|
| Email |
atalsood7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prarthana Deori |
| Designation |
Post-Graduation Trainee, MD Pharmacology |
| Affiliation |
Dr. Rajendra Prasad Government Medical College, Kangra at Tanda |
| Address |
Room 816, Department of Pharmacology
Dr. Rajendra Prasad Government Medical College Tanda, Dist Kangra
Dr. RPGMC, Tanda
Dist. Kangra, Himachal Pradesh
HIMACHAL PRADESH
176001
India |
| Phone |
7577971625 |
| Fax |
|
| Email |
deoriprarthana30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Prasad Government Medical College, Kangra at Tanda
PIN 176001
Dist. Kangra, Himachal Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Dr. Rajendra Prasad Government Medical College, Kangra at Tanda
PIN 176001
Dist. Kangra, Himachal Pradesh, India |
| 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 Prarthana Deori |
Dr. Rajendra Prasad Government Medical College, Kangra at Tanda |
Room 816, Department of Pharmacology, Paraclinical Block
Dr. Rajendra Prasad Government Medical College, Kangra at Tanda
Dist. Kangra, Himachal Pradesh, India
Kangra
HIMACHAL PRADESH |
7577971625
deoriprarthana30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr. RPGMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Desvenlafaxine |
Desvenlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI) causing increased synaptic concentrations of these neurotransmitters serotonin and norepinephrine in CNS. There’s a lack of alpha1 adrenergic, H1 histaminic and cholinergic receptor blocking property unlike TCAs.
It will be given orally 50 mg once daily for a duration of 4 weeks before the next review. |
| Intervention |
Duloxetine |
Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI). In diabetic peripheral neuropathy, duloxetine demonstrates efficacy in reducing neuropathic pain, improving sleep disturbances and mood.
Duloxetine inhibits presynaptic reuptake of serotonin and norepinephrine by blocking SERT
(Serotonin Transporter) and NET (Norepinephrine Transporter) that leads to increased synaptic
concentrations of serotonin and norepinephrine, ultimately enhancing the neurotransmission in pain inhibitory pathways and mood regulatory pathways.
It will be given orally 60 mg once daily for a duration of 4 weeks before the next review. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients willing to give written informed consent and are diagnosed with diabetic peripheral neuropathy will be included. |
|
| ExclusionCriteria |
| Details |
1. Less than 18 years of age
2. Pregnant and lactating women
3. Patients diagnosed with epilepsy
4. Chronic alcohol consumers
5. Participants with neuropathy due to other causes like vitamin B12 deficiency, thyroid dysfunction, occupational exposure to heavy metals like arsenic, lead, etc.
6. Patients allergic or with known contraindications to either duloxetine or desvenlafaxine |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A comparative study of safety, efficacy, quality of life outcomes of duloxetine with desvenlafaxine in adult patients of diabetic peripheral neuropathy. |
Baseline, 4 weeks, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/11/2025 |
| 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 Yet Recruiting |
| 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
|
Diabetic peripheral neuropathy is a chronic complication of diabetes mellitus, primarily involving the peripheral sensory nerves, and it presents with symptoms such as pain, tingling, burning sensations and numbness in the extremities. These symptoms significantly increase the risk of foot ulcers and lower limb amputations.
We will be comparing among two drug regimens, duloxetine and desvenlafaxine in the treatment of diabetic peripheral neuropathy in adult patients.
Publications will be done using the data and results obtained during the study. |