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The Effect of Herbal Formulation (Salvia hydrangea, Citrus aurantium,Lipiacitriodora,and elmbark) on the Amount and Intensity of Tinnitus, randomized clinical trial

Protocol summary

Summary
(1) Aim: finding the scientific evidence to comparison effect of herbal formulation 'Salvia hydrangea, Citrus aurantium,Lipiacitriodora,and elmbark' with Cinnarizine on amount and severity of tinnitus. (2) Design: this single-blind clinical trial of patients visiting the ear clinic with tinnitus problem more than 4 months, enrolled after physical examination, laboratory diagnosis, biochemistry and cell counting and audiogram definitive diagnosis mind tinnitus (pure tone). (3) Methods: the sample randomly divided into three groups: intervention with herbal formulation, intervention and treatment with placebo tablets and Cinnarizine. Before entering the study, forty people besides, during and after the intervention were evaluated clinically. Universal criteria and standards as well as those by the VAS and THI were evaluated. (4) Participant: all patients that visiting ear clinic with inclusion and exclusion criteria and past at least 4 month their tinnitus problem. (5) Interventions: after randomized, patients divided into 3 groups: group A (get Cinnarizine), group B (get herbal formulation) and group C (get placebo). All patients receive their treatment. The placebo in this study was Amidon that place in gelatin capsule. Dosage and mode of administration was educated. All people assessment before, 28 days and 56 days after the schedule has been developed and complete the VAS and THI with physical examination. (6) Main outcome measures variables: tinnitus

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013082814505N1
Registration date: 2015-07-07, 1394/04/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-07, 1394/04/16
Registrant information
Name
Mansour Soltani
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5458
Email address
msoltani.msc@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Herbal Formulation (Salvia hydrangea, Citrus aurantium,Lipiacitriodora,and elmbark) on the Amount and Intensity of Tinnitus, randomized clinical trial
Public title
The Effect of Herbal Formulation (Salvia hydrangea, Citrus aurantium,Lipiacitriodora,and elmbark) on the Amount and Intensity of Tinnitus, randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: giving consent to participate in the study, having an age of 17-70 years old, and suffering from tinnitus for more than 4 months. Exclusion criteria: otitis media, ear tumor, deformity within the ear; ototoxic drugs like gentamicin; ear surgery, pregnancy, breastfeeding or taking birth control pills, extensive surgery or blood transfusion during the previous month, kidney failure, history of stroke or thyroid disease, Otosclerosis, addiction to drugs or alcohol; occupational exposure to noise
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Ghafari Avenue, Birjand, South Khorasan, Iran
City
Birjand
Postal code
5717853577
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
1392-09-10

Health conditions studied

1

Description of health condition studied
Tinnitus
ICD-10 code
H83.3
ICD-10 code description
Noise Effects On Inner Ear

Primary outcomes

1

Description
Tinnitus Severity
Timepoint
Following at first, one month and if it was needed 2 month later
Method of measurement
Phisical Examination, Audiometry

Secondary outcomes

1

Description
Failure Criterion of Tinnitus
Timepoint
َAt First and One Month Later
Method of measurement
THI & VAS Scales

Intervention groups

1

Description
Group A: receiving Cinnarizine, after randomization we gave to patients Cinnarizine tablets of 25 mg (manufactured by Osve Company). If patients who had failed to respond effectively, (THI>30) intervention was extended for another 28 days. Data collection was based on THI and VAS criteria before 28 and 56 days after intervention.
Category
Treatment - Drugs

2

Description
Group B: receiving herbal formulation (Salvia hydrange, Citrus aurantium, Lipiacitriodora, and Elmbark), ), formulation in sealed packages (4 g of each herb and 12 g of elmbark) with a cup and recipe of herbal tea (5 g of powder of the mixed herbs in a cup of boiled water three times a day before each meal). Data collection was based on THI and VAS criteria before 28 and 56 days after intervention.
Category
Treatment - Drugs

3

Description
placebo in the form of gelatin capsules containing starch was prescribed for 28 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
ENT Clinic, Valiasr Hospital
Full name of responsible person
Dr. Mohhamadreza Mofateh
Street address
Ghafari Avenue, Birjand
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sceinces
Full name of responsible person
Asghar Zarban
Street address
Birjand University of Medical Sciences, Ghafari Avenue, Birjand, South Khorasan, Iran
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sceinces
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
Paramedic Faculty
Full name of responsible person
Mansour Soltani
Position
MSC in Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Avenue, Birjand, South Khorasan, Iran
City
Birjand
Postal code
Phone
+98 56 3244 3044
Fax
Email
msoltani.msc@bums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical Faculty
Full name of responsible person
Ghasem Karimi
Position
Specialist in ENT
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Avenue, Birjand, South Khorasan, Iran
City
Birjand
Postal code
Phone
+98 56 3244 3042
Fax
Email
ghasemkarimi@bums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Narges Moradi
Position
MSC in Nursing
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
nargesmoradi@bums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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