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CTRI Number  CTRI/2025/06/089131 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 06/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Efficacy of Waj and Pregabalin in Improving Neuropathic Symptoms in Patients with Diabetic Peripheral Neuropathy in Type 2 Diabetes Mellitus. 
Scientific Title of Study   A Clinical Study on Evaluation of Comparative Efficacy of Waj versus Pregabalin in Diabetic Peripheral Neuropathy 
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 MOHD SHAHID 
Designation  PhD Scholar 
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  DEPARTMENT OF MOALAJAT, NATIONAL INSTITUTE OF UNANI MEDICINE, MAGADI MAIN ROAD, KOTTIGEPALLYA

Bangalore
KARNATAKA
560091
India 
Phone  8610793596  
Fax    
Email  hikmathealthcare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MOHD ALEEMUDDIN QUAMRI 
Designation  PROFESSOR 
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  DEPARTMENT OF MOALAJAT, NATIONAL INSTITUTE OF UNANI MEDICINE, MAGADI MAIN ROAD, KOTTIGEPALLYA

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MOHD SHAHID 
Designation  PhD Scholar 
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  DEPARTMENT OF MOALAJAT, NATIONAL INSTITUTE OF UNANI MEDICINE, MAGADI MAIN ROAD, KOTTIGEPALLYA


KARNATAKA
560091
India 
Phone  8610793596  
Fax    
Email  hikmathealthcare@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF UNANI MEDICINE, BENGALURU 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  MAGADI MAIN ROAD, KOTTIGEPLLYA, BENGALURU 560091 
Type of Sponsor  Research institution and hospital 
 
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 MOHD SHAHID  NATIONAL INSTITUTE OF UNANI MEDICINE  DEPARTMENT OF MOALAJAT, MAGADI MAIN ROAD, KOTTIGEPLLYA
Bangalore
KARNATAKA 		 8610793596

hikmathealthcare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Pregabalin  One Capsule of Pregabalin 75 mg two times a day. 
Intervention  Waj  2 Capsules of Waj (containing 500 mg powder of Acorus calamus Linn. in each capsule) two times a day.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed cases of DPN with Type 2 DM.
History of DPN with or without medication within the period of 6 months to 60 months.
Subjects of DPN with Toronto clinical scoring system score more than 5 up to 11.
HbA1c less than 7.
All genders.
Age between 30 and 60 years.
Normotensive (without taking any anti-hypertensive medicines)
 
 
ExclusionCriteria 
Details  Known cases of peripheral nerve dysfunction; vitamin deficiency (B12 and E), peripheral vascular disease (peripheral artery disease, varicose vein, deep vein thrombosis, Raynaud’s disease, Buerger’s disease).
History of positive alcoholism.
Patient on Insulin.
Known history of thiazolidinedione antidiabetic agents (peripheral edema with pregabalin).
Patients with a history of Cancer, Autoimmune diseases (Multiple sclerosis, GB syndrome, Myasthenia gravis), and vasculitis (Polyarteritis nodusa).
Pregnant & lactating mothers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in Visual Analogue Scale (VAS)
Improvement in vibration perception threshold (VPT) 		 For VAS at every 15th day (0th, 15th, 30th, 45th, and 60th).
For VPT pre and post. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in TCSS.
Improvement in DNS.
Improvement in EuroQol 5 Dimension 5 Level (EQ 5D 5L). 		 Every 15th day (0th, 15th, 30th, 45th, and 60th). 
 
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   Phase 2 
Date of First Enrollment (India)   29/06/2025 
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="2"
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  
Subjects having clinical features of DPN will be screened, and those who fulfill the inclusion criteria should be enrolled in a 60-day clinical trial after obtaining written informed consent. They will be randomly allocated into two groups (computer-generated random numbers will be used for randomization), viz, group A and group B (n = 75 in the test and 75 in the control group). Subjects in group A will be given the test drug in the dosage form as mentioned above. Whereas, subjects in Group B will receive a capsule of Pregabalin in the above-mentioned dose. Baseline clinical parameters such as burning, aching pain, numbness, and prickling sensation will be assessed using a 10-point VAS (score 0=no symptom and 10=unbearable symptom)52 and VPT by using the NEURO TOUCH device by the investigator. DNS and TCSS will be calculated on each follow-up visit by summation of scores on all parameters for a patient. EuroQol 5 Dimension 5-Level (EQ-5D-5L) Questionnaires will be calculated at baseline and 60th day of the trial for assessing the quality of life. Follow-up will be on every 15th day, for assessment of clinical cure up to 60th day, except VPT (pre and post) and post treatment follow up for 30 days. Safety parameters will be done before and after the completion of the trial. The pre- and post-intervention objective findings (effects) will be assessed statistically. All the above interventions will be using orally for 60 days. The Frequency & dose of rescue medicine mentioned in each group. The objective parameters VAS will be measured at baseline, 15th day, 30th day, 45th day, and 60th day, and & VPT at baseline and 60th day respectively.
Statistical Analysis
Efficacy analysis will be performed on intention-to-treat (ITT) principles using the last observation carry forward method (LOCF). The study data will be analysed statistically with appropriate tests. Changes in various parameters will be assessed for statistical evaluation by using a categorical scale, non non-parametric setting for qualitative data analysis. Whereas, repeated measures ANOVA and one-way ANOVA with Tukey post hoc multiple comparison test (on continuous scale) for both intergroup & intragroup analysis at every follow-up. Leven`s test will be performed to assess the homogeneity of variance. Results on continuous measurements will be presented on Mean, SD, and results on categorical measurements will be presented in Number (%). 
 
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