Evaluation of the effect of Nanocurcumin Supplement in Treatment of Tinnitus
Design
Clinical Trial with Control Group, With Parallel Groups, Triple Blind, Randomized
Settings and conduct
This Study will be Performed with Randomized Controlled Trial among 62 patient with Tinnitus that refer to Besat Hospital in Hamadan . The following will be performed for Audiometric patients including Pure Tone, Speech Perception Threshold, Speech Dissociation Criterion, and Tinnitus Matching Test to assess Tinnitus frequency and loudness.With Impedance Testing will assess Middle ear bone disorders, as well as serous fluid or infection, and Middle ear muscle reflexes. Patients will then be randomly divided into two groups receiving Nano Curcumin and Placebo and the intervention will be performed. After intervention, Tinnitus Conformity Test Questionnaire will be performed and changes recorded and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Unilateral or Bilateral Subjective Tinnitus; 18-65 Year; Patients do not have Pregnancy and Breastfeeding; Patients do not have Acute or Chronic Ear Infection; Patients do not have Rheumatologic Diseases, Vasculitis, Acoustic Neuroma, Known Neurological Disorders and Ear Surgery; Patients not taking Immunosuppressants such as Interferons, Corticosteroids, Anticonvulsants and Sedatives before starting the study
Exclusion Criteria is Failure to Cooperate patients
Intervention groups
The Intervention group will Consume Sina 80 mg Nano Nurcumin Supplement with Meals for 21 days . The Control group will consume one Placebo daily for 21 days.
Main outcome variables
Tinitus loudness, Tinnitus Pitch, Tinnitus Handicap Inventory, Side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190916044785N1
Registration date:2019-10-20, 1398/07/28
Registration timing:registered_while_recruiting
Last update:2019-10-20, 1398/07/28
Update count:0
Registration date
2019-10-20, 1398/07/28
Registrant information
Name
Farhad Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3264 0021
Email address
dr_f_farahani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of The Effect of Nanocurcumin on Treatment of Tinnitus:A Triple Blinded Randomized Clinical Trial
Public title
Evaluation of The Effect of Nanocurcumin on Treatment of Tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral or Bilateral Subjective Tinnitus
Age Range: 18-65 Year
Patients do not have Pregnancy and Breastfeeding
Patients do not have Acute or Chronic Ear Infection
Patients do not have Rheumatologic Diseases, Vasculitis, Acoustic Neuroma, Known Neurological Disorders and Ear Surgery
Patients not taking Immunosuppressants such as Interferons, Corticosteroids, Anticonvulsants and Sedatives before starting the study
Exclusion criteria:
Patients who do not willing to enter the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
We will write two letter Asheets and two letter B sheets. Mix the sheets together. We will place one in the drawer of the table. Each eligible patient will be randomly pulled out and given A or B drawn. It should be noted that these extruded sheets will not be returned to the drawer until all four sheets have been extracted. In the four sheets, all the sheets are returned to the drawer and the same procedure will continue for the next four patients until the desired sample size is reached
Blinding (investigator's opinion)
Triple blinded
Blinding description
Drugs are excluded from the drug cover and given to the patient without the name of the drug in the envelopes containing Addicts A and B. Therefore, the patient will not be informed of the type of drug used. Therefore, the examining physician will not be aware of the type of drug used by the patients. The intervention and comparison groups will be coded and the data analyst will not be informed of the intervention type. Thus, the study will be conducted in a triple blind manner
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Science
Street address
Research and Technology Vice Chancellor, Hamadan University of Medical Sciences, In front of Mardom Park, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.UMSHA.REC.1398.467
Health conditions studied
1
Description of health condition studied
tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Tinnitus Handicap Inventory
Timepoint
Before and after 21 days of Medicine Consumption
Method of measurement
Tinitus Matching Test
Secondary outcomes
empty
Intervention groups
1
Description
The Intervention group will Consume Sina 80 mg Nano curcumin Supplement with Meals for 21 days .
Category
Treatment - Drugs
2
Description
Control group: The Control group will consume Placebo capsul once a day for 21 days. Capsuls are desigend in the same shape with curcumin.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Farhad Farahani
Street address
Next to ENT Clinic, Besat Hospital, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6514845471
Phone
+98 81 3264 0021
Email
dr_f_farahani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Research and Technology Vice-Chancellor, Hamadan University of Medical Sciences, In Front of Mardom Park, Hamadan