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Trial registered on ANZCTR


Registration number
ACTRN12609000065291
Ethics application status
Approved
Date submitted
27/10/2008
Date registered
27/01/2009
Date last updated
27/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multicenter Clinical Trial of Neurotec in Fibromyalgia Syndrome
Scientific title
Multi-Centre Randomised Double Blind Placebo Controlled Clinical Trial of the Effect of Neurotec in Fibromyalgia Syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia Syndrome 3876 0
Condition category
Condition code
Musculoskeletal 4076 4076 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adminstration of Oral form of herbal component ''Neurotec'' as capsules containing 120mg of active ingredient(which belong to Flavonoids:Isoquercetin,4-Methoxyisoquercetin and Rutin) in patients with diagnosis of fibromyalgia according to American College of Rheumatology (ACR) criteria. Patients will take the drug as oral, twice a day for 8 weeks.
Intervention code [1] 3604 0
Treatment: Drugs
Comparator / control treatment
Adminstration of Oral form ''Placebo''. Placebo has been made as capsules exactly similar to drug containing starch. Patients will take Placebo as oral, twice a day for 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 4974 0
Number of tender points (out of 18 possible tender points). This can be achieved through physical examination by the trained reumatologist.
Timepoint [1] 4974 0
Patients will be visited every other week by a Rheumatologist during the first 8 weeks and every 4 weeks during thereafter untill 16th week from the start of treatment
Primary outcome [2] 4975 0
Pain severity (sum of numerical scale of tender points).The patients will express the severity of the pain they feel in tender points according the numrical scale from min=0 to highest=10
The severity of pain for each tender point will be measured through a numerical Scale.
Timepoint [2] 4975 0
Patients will be visited every other week by a Rheumatologist during the first 8 weeks and every 4 weeks during thereafter untill 16th week from the start of treatment
Secondary outcome [1] 8389 0
Quality of life
This will be measured through applying SF-12 questionnaire which is a 12-item questionnaire for measuring both physical and mental aspect of quality of life.
Timepoint [1] 8389 0
At baseline, 8th and 16th week of study
Secondary outcome [2] 8390 0
Quality of life assessed by Fibromyalgia Impact Questionnaire (FIQ)
Timepoint [2] 8390 0
Patients will be visited every other week by a Rheumatologist during the first 8 weeks
Secondary outcome [3] 8391 0
Cattell Anxiety Scale (CAS)
Timepoint [3] 8391 0
At baseline, 8th and 16th week of study
Secondary outcome [4] 8392 0
Beck Depression Inventory (BDI)
Timepoint [4] 8392 0
At baseline, 8th and 16th week of study
Secondary outcome [5] 8393 0
Changes in disease condition assessed by Clinical Global Impression of Change (CGIC) & Patient Global Impression of Change (PGIC)
Timepoint [5] 8393 0
At 8th and 16th week of the study

Eligibility
Key inclusion criteria
Diagnosis of Fibromyalgia defined by American college of Rheumatology criteria (Tenderness on at least 11 out of 18 points)
Age more than 18 year
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of any other rheumatologic diseases
Receiving any investigational drug within 30 days prior to screening
Presence of any other systemic or chronic diseases such as: Myopathy, Vasculitis, Peripheral Vascular Diseases, Chronic hepatic or renal diseases, clinically complicating pulmonary, Cardiac, Hematologic, Gastrointestinal, Endocrine disease or Malignancy.
Pregnancy or intention of becoming pregnant during the study period (1 year)
Inability to give informed consent according to the agreed process
Corticosteroid therapy
Any drug hypersensitivity
Radiotherapy, Chemotherapy or any immuosuppressive drug use
Electrolyte imbalance

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will not be exposed to those conducting the study and will be provided in closed letters with successive numbers. The envelope will be opened when a patient is going to join the study.
The study will be double blind. The patient, those who conduct the study and those who analyse the results will be unaware of the state of the patient with regard to receiving the active drug or placebo. For this to happen patients will be blinded by using a placebo which is identical to active drug in appearance but the content is a biologically inert substance. To blind those who conduct the study, the person who delivers the study drug will be different from those who examine the patients. Finally the randomisation table will be concealed from research staff by using closed envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There are 11 centres. Patients in each centre will be allocated to the intervention or control groups using a separate complete block randomisation method. Randomisation will not be exposed to those conducting the study and will be provided in closed letters with successive numbers. The envelope will be opened when a patient is going to join the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1307 0
Iran, Islamic Republic Of
State/province [1] 1307 0
Tehran

Funding & Sponsors
Funding source category [1] 4066 0
Commercial sector/Industry
Name [1] 4066 0
Pars Roos
Address [1] 4066 0
No:568, 13th Alley, Hormozan St., Shahrak-e-Gharb, tehran,1466793143
Country [1] 4066 0
Iran, Islamic Republic Of
Primary sponsor type
Other Collaborative groups
Name
Iran Rheumatology Center
Address
No9, Khosravi Alley, North Kargar St., Tehran, 1413633131
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3738 0
None
Name [1] 3738 0
Address [1] 3738 0
Country [1] 3738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6149 0
Endocrine & Metabolism Research Center Ethic Committee
Ethics committee address [1] 6149 0
Fifth Floor, Shariaty Hospital, North Kargar St., Tehran, 14114
Ethics committee country [1] 6149 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6149 0
23/09/2008
Approval date [1] 6149 0
27/10/2008
Ethics approval number [1] 6149 0
E-0009

Summary
Brief summary
This is a Phase III multicenter clinical trial of the herbal oral component of Neurotec in patients with Fibromyalgia.The intervention period is 8 weeks and patients will be followed for another 8 weeks after the end of intervention. This study will be conducted with control group with Placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29073 0
Address 29073 0
Country 29073 0
Phone 29073 0
Fax 29073 0
Email 29073 0
Contact person for public queries
Name 12230 0
Dr.Ahmad Reza Jamshidi
Address 12230 0
No9, Khosravi Alley, North Kargar St., Tehran, 1413633131
Country 12230 0
Iran, Islamic Republic Of
Phone 12230 0
+98 21 88004136
Fax 12230 0
+98 21 88028166
Email 12230 0
jamshida@sina.tums.ac.ir
Contact person for scientific queries
Name 3158 0
Dr.Ahmad Reza Jamshidi
Address 3158 0
No9, Khosravi Alley, North Kargar St., Tehran, 1413633131
Country 3158 0
Iran, Islamic Republic Of
Phone 3158 0
+98 21 88004136
Fax 3158 0
+98 21 88028166
Email 3158 0
jamshida@sina.tums.ac.ir

No data has been provided for results reporting
Summary results
Not applicable