Pragmatic, community based, parallel group, double blind, randomised controlled trial
Settings and conduct
This study is designed as a parallel group, double blind, randomised controlled trial. The patients with tinnitus (sample size: 60 patients) who admitted to AmirAlam Hospital in Tehran, who have inclusion criteria, will included in this study. Written informed consent from patients is mandatory for entering to the study. In this study patients and physician are blinded. Drugs are labelled with similar labels by a third person with unique identification codes for future identification.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with unknown cause tinnitus
Exclusion criteria: Patients with history of head and neck surgery, pregnant or lactating women, history of turmeric allergy, having gallstones or biliary obstruction
Intervention groups
Thirty patients will receive nanocurcumin softgel capsule once daily for three months; and another 30 patients will receive placebo softgel capsules once daily for three months.
Main outcome variables
treatment of tinnitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029327N15
Registration date:2018-07-25, 1397/05/03
Registration timing:registered_while_recruiting
Last update:2018-07-25, 1397/05/03
Update count:0
Registration date
2018-07-25, 1397/05/03
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nanocurcumin in the treatment of tinnitus
Public title
The effect of Nanocurcumin in Tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of the patients with unknown cause tinnitus
Exclusion criteria:
History of head and neck surgery
Pregnant or lactating women
History of turmeric sensitivity
Gallstones or biliary obstruction
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table: based on Random Sequence Generator via random.org website two groups were made. Patients were allocated in one of two groups based on their entry sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study in which both researcher and patients don't know that which drug the patient have been used. Drugs will be dispensed by a third person in uniform packages with codes. Instructions on the number of consumption will not be seen by the prescriber.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Pharmaceutical Sciences
Street address
#99,The First of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
19395-6466
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
IR.IAU.PS.REC.1396.148
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus, bilateral
Primary outcomes
1
Description
Tinnitus Status
Timepoint
Before treatment, 4 and 12 weeks after treatment
Method of measurement
Iowa Tinnitus Primary Function Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in people with inclusion criteria to be given 80mg oral Nanocurcumin softgel capsule, 4 times daily, for three month.
Category
Treatment - Drugs
2
Description
Control group: in people with inclusion criteria to be given oral placebo capsule one time daily for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir A'lam Hospital
Full name of responsible person
Sahar Hasani
Street address
Sa'di Ave.,Enghelab st.,
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 6672 7060
Email
saharhasani290@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
sahar Hasani
Street address
Yakhchal St, Shariati st.
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2200 4355
Email
saharhasani290@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
#99, the first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21226400515
Email
r_abrishami@iaups.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
#99, The first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21226400515
Email
r_abrishami@iaups.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
#99, The first of Yakhchal Ave., Gholhak, Shariati St
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21226400515
Email
r_abrishami@iaups.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Patients' Demographic Data, Scores of the Tinnitus primary Function Questionnaire
When the data will become available and for how long
After publication of paper, for one year
To whom data/document is available
To academic persons
Under which criteria data/document could be used
User should cite the primary document
From where data/document is obtainable
Via email to corresponding author
What processes are involved for a request to access data/document