Comparison of the Efficacy of Gabapentin With Loratadine in the Treatment of Uremic Pruritus in Patients of Chronic Kidney Disease
Phase: PHASE4
Conditions: Pruritus, Uremia, Chronic Kidney Diseases
Sponsor: King Edward Medical University

Comparison of the Efficacy of 
Gabapentin With Loratadine in the 
Treatment of Uremic Pruritus in 
Patients of Chronic Kidney Disease. 
 
NCT05750875 
01/06/2021 

Proforma 
 
Comparison of the efficacy of gabapentin with loratadine in the treatment of 
uremic pruritus in patients of chronic kidney disease 
 
Patient No.:
Visit No.: 
Date: 
Group: 
Name: 
Age/Sex: 
Weight: 
Profession 
Residence: 
Contact No.: 
Labs: 
CBC: 
LFTs: 
RFTs: 
S/E: 
Hb: 
Bil: 
Urea: 
Na: 
WBC: 
ALT: 
Creat: 
K: 
PLT: 
AST: 
Ca: 
ALP: 
Albumin: 
PO4 
 
USG findings: 
 
GFR: 
Stage of CKD: 
Undergoing Dialysis: Yes/ No 
Pruritis: 
Duration: 
Frequency/week: 
Severity: 
 
No itch 
Severe itch 
 
 
 
 
 
 
Adverse events: 

YES 
NO 
Drowsiness ם ם 
Dizziness ם ם 
Fatigue ם ם 
Blurred/Double vision ם ם 
Tremors ם ם 
Gastro-intestinal symptoms 
(nausea, vomiting, diarrhea, abdominal pain) ם ם 
Headache ם ם 
Dry mouth ם ם 
Palpitations ם ם 
Allergic reaction 
(rash, swelling, wheeze) 
ם ם 
Any other: 

AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the permission of the authors. 
 
DERMATOLOGY LIFE QUALITY INDEX (DLQI) 
Hospital No: ……………………………………. 
Date: 
……………………. 
Name: 
……………………………………. 
Score: 
……………………. 
Address: 
……………………………………. 
Diagnosis: ……………………. 
……………………………………. 
 
The aim of this questionnaire is to measure how much your skin problem has affected your life 
OVER THE LAST WEEK. Please tick () one box for each question. 
 
1. 
Over the last week, how itchy, sore, painful or stinging 
has your skin been? 
 
 
2. 
Over the last week, how embarrassed or self conscious 
have you been because of your skin? 
 
 
3. 
Over the last week, how much has your skin interfered with 
you going shopping or looking after your home or garden? 
 
 
4. 
Over the last week, how much has your skin influenced the 
clothes you wear? 
 
 
5. 
Over the last week, how much has your skin affected any 
social or leisure activities? 
 
 
6. 
Over the last week, how much has your skin made it difficult 
for you to do any sport? 
 
 
7. 
Over the last week, has your skin prevented you from 
working or studying? 
 
If "No", over the last week how much has your skin been a 
problem at work or studying? 
 
8. 
Over the last week, how much has your skin created 
problems with your partner or any of your close friends or 
relatives? 
 
9. 
Over the last week, how much has your skin caused any 
sexual difficulties? 
 
 
10. Over the last week, how much of a problem has the 
treatment for your skin been, for example by making your 
home messy, or by taking up time? 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Yes 
No 
 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 











 
Not relevant 




 
Not relevant 




 
Not relevant 




 
Not relevant 


 
Not relevant 








 
Not relevant 




 
Not relevant 




 
Not relevant 


Please check you have answered EVERY question. Thank you. 

AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the permission of the authors. 
 
DERMATOLOGY LIFE QUALITY INDEX (DLQI) - INSTRUCTIONS FOR USE 
 
The Dermatology Life Quality Index questionnaire is designed for use in adults, i.e. patients over the age of 
16. It is self explanatory and can be simply handed to the patient who is asked to fill it in without the need for 
detailed explanation. It is usually completed in one or two minutes. 
 
 
SCORING 
 
The scoring of each question is as follows: 
Very much 
scored 3 
A lot 
scored 2 
A little 
scored 1 
Not at all 
scored 0 
Not relevant 
scored 0 
Question 7, ‘prevented work or studying’ 
scored 3 
 
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum 
of 0. The higher the score, the more quality of life is impaired. 
 
 
HOW TO INTERPRET MEANING OF DLQI SCORES 
 
0 – 1 
no effect at all on patient's life 
2 – 5 
small effect on patient's life 
6 – 10 
moderate effect on patient's life 
11 – 20 
very large effect on patient's life 
21 – 30 
extremely large effect on patient's life 
 
 
REFERENCES 
 
Finlay AY and Khan GK. Dermatology Life Quality Index (DLQI): a simple practical measure for routine 
clinical use. Clin Exp Dermatol 1994; 19:210-216. 
 
Basra MK, Fenech R, Gatt RM, Salek MS and Finlay AY. The Dermatology Life Quality Index 1994-2007: a 
comprehensive review of validation data and clinical results. Br J Dermatol 2008; 159:997-1035. 
 
Hongbo Y, Thomas CL, Harrison MA, Salek MS and Finlay AY. Translating the science of quality of life into 
practice: What do dermatology life quality index scores mean? J Invest Dermatol 2005; 125:659-64. 
 
 
 
There is more information about the DLQI, including over 85 translations, at www.dermatology.org.uk. The 
DLQI is copyright but may be used without seeking permission by clinicians for routine clinical purposes. For 
other purposes, please contact the copyright owners. 

 
PATIENT INFORMED CONSENT 
 
 
 
I agree to participate in the study titled: 
 
 
Comparison of the efficacy of gabapentin with loratadine in the treatment of uremic pruritus 
in patients of chronic kidney disease. 
 
 
I have been informed in detail about the study and the possible benefits and side effects of this 
study. I understand that my participation is voluntary and that I am free to withdraw at any 
time, without my medical care or legal rights being affected. I allow my doctor or any other 
person authorized by my doctor to contact me at my home or at an address given by me for 
treatment and follow up. 
I have been assured that the information provided by me will be kept confidential and will be 
used for research purpose only. 
 
 
 
 
Patient Name:   
 
CNIC No.:  
  
Signature: 
 
Date:   
 
Witness name:   
 
CNIC No.:   
  
Signature: 
 
 
Date:   
 
 
 
 
 
Researcher Signature:   
 
 
Date: 
 
 
CNIC No.: