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CTRI Number  CTRI/2026/04/107346 [Registered on: 01/04/2026] Trial Registered Prospectively
Last Modified On: 01/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Evaluation of Efficacy and Safety of Duloxetine, Amitriptyline, and Gabapentin for Diabetic Polyneuropathy patients. 
Scientific Title of Study   Evaluation of Efficacy and Safety of Duloxetine, Amitriptyline, and Gabapentin for Diabetic Polyneuropathy patients: A Prospective Observational Study 
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 Radhika lakhtariya  
Designation  PG Resident department of pharmacology  
Affiliation  GEETANJALI MEDICAL COLLEGE AND HOSPITAL ,UDAIPUR 
Address  room no 601, 6th floor department of pharmacology, Geetanjali medical college and hospital, Eklingpura, Hiranmagari, Udaipur, Rajasthan
PG room,6th floor department of pharmacology, Geetanjali medical college and hospital, Eklingpura, Hiranmagari, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313002
India 
Phone  6355155794  
Fax    
Email  drradhikalakhtariya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangita gupta  
Designation  Professor department of pharmacology  
Affiliation  GEETANJALI MEDICAL COLLEGE AND HOSPITAL UDAIPUR 
Address  room no.602,6th floor, Department of pharmacology, Geetanjali medical college and hospital, Eklingpura, Hiranmagari, Udaipur, Rajasthan
room no.602,6th floor, Department of pharmacology, Geetanjali medical college and hospital, Eklingpura, Hiranmagari, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313002
India 
Phone  9829203024  
Fax    
Email  sangitaarungupta57@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Sangita gupta  
Designation  Professor department of pharmacology  
Affiliation  GEETANJALI MEDICAL COLLEGE AND HOSPITAL UDAIPUR 
Address  room no 602,6th floor,department of pharmacology, Geetanjali medical college and hospital, Eklingpura, Hiranmagari, Udaipur, Rajasthan
room no.602,6th floor, Department of pharmacology, Geetanjali medical college and hospital, Eklingpura, Hiranmagari, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313002
India 
Phone  9829203024  
Fax    
Email  sangitaarungupta57@gmail.com   
 
Source of Monetary or Material Support  
Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India Pin code 313002 
 
Primary Sponsor  
Name  Dr Radhika Lakhtariya 
Address  Department of pharmacology, Resident room , Geetanjali Medical College and Hospital, Udaipur, Rajasthan, Pin code 313002  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Radhika Lakhtariya   Outpatient Department of Neurology, Geetanjali Medical College and Hospital, Udaipur  Room no 102,1st floor, Department of Neurology Geetanjali Medical College and Hospital, Eklingpura, Hiranmagari, Udaipur, Rajasthan, Pin code 313002
Udaipur
RAJASTHAN 		 06355155794

drradhikalakhtariya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E084||Diabetes mellitus due to underlying condition with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Adults 18 years or more than 18 years with clinical diagnosis of diabetic polyneuropathy
2 willingness to provide informed consent and comply with study procedures 
 
ExclusionCriteria 
Details  1 Severe renal or hepatic impairment
2 Use of other neuropathic pain medications
3 History of substance abuse
4 Pregnancy or lactation
5 Hypersensitivity or allergy to study drugs (duloxetine, amitriptyline, and gabapentin)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Primary Outcomes:
o Change in Visual Analog Scale (VAS) for pain from baseline to 6 weeks
o Change in burning sensation severity from baseline to 6 weeks
o Change in anxiety from baseline to 6 weeks
o Change in sleep disturbance from baseline to 6 weeks
 		 from baseline to follow up after 6 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
• Secondary Outcomes:
o Incidence of adverse events: sedation, dizziness, edema, urinary retention, dry mouth etc.
 		 from baseline to follow up after 6 weeks  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   14/04/2026 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drradhikalakhtariya@gmail.com].

  6. For how long will this data be available start date provided 11-04-2026 and end date provided 16-12-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary  

This study will be a prospective, observational  study to evaluate the efficacy and safety of duloxetine, amitriptyline, and gabapentin in patients with diabetic polyneuropathy, conducted in the Departments of Pharmacology and Neurology at Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India. A total of 90 adult patients with clinically diagnosed diabetic polyneuropathy confirmed by nerve conduction study, newly prescribed duloxetine 30 mg once daily, amitriptyline 10 mg at bedtime, or gabapentin 300 mg once daily, will be included. Primary outcomes will include changes in pain severity assessed by Visual Analog Scale (VAS), burning sensation, anxiety symptoms, and sleep disturbance using Likert scales from baseline to 6 weeks, while secondary outcomes will include incidence of adverse effects such as sedation, dizziness, edema, urinary retention, and dry mouth. Comparative analysis among the three groups will help determine the most effective and safest treatment option for diabetic polyneuropathy patients.

 
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