The impact of the herbal compound of corcomin- piperin and gingerol on Sudden sensorineural hearing loss in diabetic patients referred to Tehran Amir Alam and Khomeini Hospitals
Aim of study: The aim of this study was to determine the effect of curcumin, piperine and gingerol component on hearing repair in diabetic patient with Sudden Sensorineural Hearing Loss
Inclusion criteria: Type 2 diabetic patients with Sudden Sensorineural Hearing Loss in the age group of 20-65.
Exclusion criteria: Presence of any cardiovascular disease, gastrointestinal disease, hypoglycaemia history , History of anticoagulant therapy, pregnancy and Lactation
The study population: Diabetic patient with Sudden Sensorineural Hearing Loss referred to Amir-Alam and Vali- Asr hospitals
Sample size: 51 cases
Intervention: This study will have 3 arms , The first arm included patients will be eligible for injection 0.3-0.5 ml dexamethasone twice a week over six times in the middle ear with consume placebo capsules two a day for two months.
The second arm included patients will be eligible for injection 0.3-0.5 ml dexamethasone twice a week over six times in the middle ear with consume Mixodin capsules ( 300 mg of curcumin , 3.25 mg Piperine and 7.5 mg of gingerol) one a day and consume placebo capsules one a day for two months.
The third arm included patients will be eligible for injection 0.3-0.5 ml dexamethasone twice a week over six times in the middle ear with consume Mixodin capsules (300 mg of curcumin , 3.25 mg Piperine and 7.5 mg of gingerol) two a day for two months.
Primary outcome measure: Changes in hearing threshold
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012332132N1
Registration date:2017-05-05, 1396/02/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-05, 1396/02/15
Registrant information
Name
Ali Reza Karimi Yazdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1628
Email address
karimiya@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2017-10-12, 1396/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of the herbal compound of corcomin- piperin and gingerol on Sudden sensorineural hearing loss in diabetic patients referred to Tehran Amir Alam and Khomeini Hospitals
Public title
The impact of the herbal compound of Turmeric- Black pepper and ginger extract on Sudden sensorineural hearing loss in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetic patients with Sudden Sensorineural Hearing Loss in the age group of 20-65 y.
Exclusion criteria: Presence of any cardiovascular disease; gastrointestinal disease; Hypoglycemia; History of anticoagulant therapy; Pregnancy; and Lactation
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
51
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Keshavarz, BLV
City
ENT Research Center, Amir-Alam hospital, Imam Khomeini Hospital Complex. Keshavarz Blvd. Tehran,Iran
Postal code
Approval date
2016-12-20, 1395/09/30
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1271
Health conditions studied
1
Description of health condition studied
Sudden Sensorineural Hearing Loss
ICD-10 code
H91.2
ICD-10 code description
Sudden idiopathic hearing loss
Primary outcomes
1
Description
Changes in hearing threshold
Timepoint
Before the intervention, sixth week, third week, eighth week after the intervention
Method of measurement
examination, interview, audiometry
Secondary outcomes
1
Description
Tinnitus
Timepoint
before intervention, The third week, sixth and eighth
Method of measurement
Examination and interview
2
Description
Dizziness
Timepoint
Before the intervention, the third week, sixth and eighth
Method of measurement
Examination and interview
Intervention groups
1
Description
The first group included patients will be eligible for injection 0.3-0.5 ml dexamethasone twice a week over six times in the middle ear with consume placebo capsules two a day for two months
Category
Treatment - Drugs
2
Description
The second group included patients will be eligible for injection 0.3-0.5 ml dexamethasone twice a week over six times in the middle ear with consume Mixodin capsules( 300 mg of curcumin 3.25 mg Piperine and 7.5 mg of gingerol) one a day and consume placebo capsules one a day for two months
Category
Treatment - Drugs
3
Description
The third group included patients will be eligible for injection 0.3-0.5 ml dexamethasone twice a week over six times in the middle ear with consume Mixodin capsules( 300 mg of curcumin , 3.25 mg Piperine and 7.5 mg of gingerol) two a day for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr.Ali Reza Karimi Yazdi
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Dr.Ardavan Taj dini
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
masud yunesian
Street address
Tehran University of Medical Scinces, Ghods squareTehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Leyla Sahebi
Position
Assistant profesor
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1628
Fax
Email
sahebileila@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Alireza Karimi Yazdi
Position
professor
Other areas of specialty/work
Street address
ENT research centert, Vali-Asr hospital, Imam Khomeini complex hospital, Tehran,Iran.
City
Tehran
Postal code
Phone
+98 21 6658 1628
Fax
Email
karimiya@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Sahebi
Position
Assistant professor
Other areas of specialty/work
Street address
ENT researc center, Vali-Asr hospital, Imam Khomeini complex hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+216 581628
Fax
+216 581628
Email
sahebileila@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)