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CTRI Number  CTRI/2020/01/022613 [Registered on: 06/01/2020] Trial Registered Prospectively
Last Modified On: 03/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Olfactory training]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing smell training and a medicine in the treatment of patients with loss of smell 
Scientific Title of Study   EFFECTIVENESS OF OLFACTORY TRAINING AND ALPHALIPOIC ACID IN THE TREATMENT OF SEVERE OLFACTORY DYSFUNCTION- 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  Berenice Stella B 
Designation  Postgraduate Registrar 
Affiliation  Christian Medical College 
Address  Department of ENT , Christian Medical College, Vellore 632004

Vellore
TAMIL NADU
632004
India 
Phone  7708355765  
Fax    
Email  solomon.bernice@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Lalee Varghese 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of ENT , Christian Medical College, Vellore 632004
Christian Medical College, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162283483  
Fax    
Email  laleevarghese@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Berenice Stella B 
Designation  Postgraduate Registrar 
Affiliation  Christian Medical College 
Address  Department of ENT , Christian Medical College, Vellore 632004

Vellore
TAMIL NADU
632004
India 
Phone  7708355765  
Fax    
Email  solomon.bernice@gmail.com  
 
Source of Monetary or Material Support  
Institutional Review Board,Christian Medical College, Vellore, TamilNadu 632004 
 
Primary Sponsor  
Name  Christian medical College 
Address  Christian Medical College, Vellore 632004 
Type of Sponsor  Private medical college 
 
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 Berenice Stella B  Christian Medical College, Vellore  Department of ENT, Unit 3, Room no.303
Vellore
TAMIL NADU 		 7708355765

solomon.bernice@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Christian Medical College, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alphalipoic acid  All patients fulfilling the inclusion criteria will be asked to fill the Self administered odour questionnaire (SAOQ) and grade the severity of their olfactory loss based on a visual analog scale. Objective olfactory assessment will then be done using Connecticut Chemosensory Clinical Research Center (CCCRC) Test. After the initial assessment, study population will be divided into two groups – Group A would receive olfactory retraining therapy, and Group B would receive olfactory training(patient has to smell 4 different odors for 15 seconds each twice a day for 3 months) and alpha lipoic acid (600mg once a day taken orally for three months). These recruited patients will be followed up after 3 months of initiation of therapy, subjective and objective evaluations repeated using the same SAOQ questionnaire, olfaction tests and VAS score to see if there is any change.  
Comparator Agent  Olfactory training alone  All patients fulfilling the inclusion criteria will be asked to fill the Self administered odour questionnaire (SAOQ) and grade the severity of their olfactory loss based on a visual analog scale. Objective olfactory assessment will then be done using Connecticut Chemosensory Clinical Research Center (CCCRC) Test. After the initial assessment, study population will be divided into two groups – Group A would receive olfactory retraining therapy( patient has to smell four different odors for 15 seconds each twice daily for 3 months) 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients above 16 years of age
History of loss of smell
Severe hyposmia or anosmia on evaluation
No identifiable cause
 
 
ExclusionCriteria 
Details  Patients below 16 years of age
Pregnancy
Etiology of smell loss other than post infectious or idiopathic
Prior sinus, skull base or brain surgery
Cognitive or psychiatric dysfunction
Head injury
Patients having nasal mass

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Olfaction test scores (Threshold score,
identification score and composite score) post treatment
 		 At the end of 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Visual Analogue Score and Self Administered Odor Questionaire scores post treatment  two and a half years 
 
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   Phase 3 
Date of First Enrollment (India)   06/01/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Olfactory loss has been shown to have a negative impact in the quality of life, by preventing the detection of hazardous smells like smoke, gas leaks and chemicals. It also prevents the patients from enjoying food thereby resulting in weight loss or gain and psychological distress. The inability to percieve smell is termed as anosmia while the reduced perception to smell is hyposmia. The treatment options for smell loss are limited. However, regular structured exposure to odors through olfactory training has been found to be effective by stimulation of the olfactory neuroepithelium, although the exact mechanism is unknown. Likewise, alpha lipoic acid with their antioxidant effect has also been found to improve the sense of smell in olfactory loss patients. This study aims to compare the efficacy of olfactory training and alpha lipoic acid in the improvement of smell in post viral and idiopathic olfactory loss patients. 
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