The objective of this study is to determine the effect of Neurotec (a herbal drug) on the Fibromyalgia syndrome. 200 patients who meet the ACR (American College of Rheumatology) criteria and have not any other chronic or systematic diseases will be recruited in 11 academic centres in Iran (6 centres in Tehran and centres of Isfahan, Mashhad, Kerman, Ahvaz, and Yazd).The patients will randomized into two groups through a complete block randomization method separately in each centre and recieve Neurotec (120 mg, one capsule) twice a day or placebo. The duration of treatment period will be 8 weeks and the patients will be visited every other week by a rheumatologist during this period. They will also be followed up for another 2 month-period and will be visited every month. Primary outcome measure of this study is pain which will be measured through the number of tender points and sum of the severities of pain on tender points. Other outcome measures are severity of Fibromyalgia which will be measured through Fibromyalgia Impact Questionnaire (FIQ), anxiety, depression, quality of life, sleep, Patient's Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC) and adverse effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138708061411N2
Registration date:2009-06-16, 1388/03/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-06-16, 1388/03/26
Registrant information
Name
Ahmad Reza Jamshidi
Name of organization / entity
Iran Rheumatology Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 4136
Email address
jamshida@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pars Roos Co.
Expected recruitment start date
2008-11-24, 1387/09/04
Expected recruitment end date
2009-05-24, 1388/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Multi-Centre Randomised Double Blind Placebo Controlled Clinical Trial of the Effect of Neurotec in Fibromyalgia Syndrome
Public title
Multi-Centre Randomised Double Blind Placebo Controlled Clinical Trial of the Effect of Neurotec in Fibromyalgia Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosis of Fibromyalgia defined by American college of Rheumatology criteria (History of widespread pain has been present for at least three months and tenderness on at least 11 out of 18 points)
Age more than 18 year
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 (4 months)
Inability to give informed consent according to the agreed process
Corticosteroid therapy
Any drug hypersensitivity
Radiotherapy, Chemotherapy or any immuosuppressive drug use
Electrolyte imbalance
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Endocrine & Metabolism Research Center, Ethic Committe
Street address
Fifth Floor, Shariati Hospital, North Kargar St., Tehran, Iran
City
Tehran
Postal code
14114
Approval date
empty
Ethics committee reference number
E-0009
Health conditions studied
1
Description of health condition studied
Fibromyalgia Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of Pain
Timepoint
Baseline, second, 4th, 6th, 8th, 12th and 16th weeks of the study
Method of measurement
Sum of severities of tenderpoint via an 11-point scale (0-10)
2
Description
Number of tender points
Timepoint
Baseline, second, 4th, 6th, 8th, 12th and 16th weeks of the study
Method of measurement
number of tender points(out of 18 points based on the American College of Rheumatology)
Secondary outcomes
1
Description
Fibromyalgia Severity
Timepoint
Baseline, second, 4th, 6th, 8th, 12th and 16th weeks of the study
Method of measurement
Fibromyalgia Impact Questionnaire (FIQ)
2
Description
Anxiety
Timepoint
Baseline, 4th, 8th, and 16th week
Method of measurement
Cattell Anxiety Scale
3
Description
Depression
Timepoint
Baseline, 4th, 8th, and 16th week
Method of measurement
Beck Depression Inventory
4
Description
Quality of Life
Timepoint
Baseline, 4th, 8th, and 16th week
Method of measurement
SF-12
5
Description
Sleep
Timepoint
Baseline, 4th, 8th, and 16th week
Method of measurement
Separate questions of adequacy and quality of sleep
6
Description
Patient's Global Impression Change (PGIC)
Timepoint
At the end of 8th and 16th week
Method of measurement
10-point Likert scale (very poor to very improved)
7
Description
Clinical Global Impression of Change (CGIC)
Timepoint
At the end of 8th and 16th week
Method of measurement
10-point Likert scale (very poor to very improved)
8
Description
Adverse effects
Timepoint
Baseline, second, 4th, 6th, 8th, 12th and 16th weeks of the study
Method of measurement
Patient's reports and physical examination and lab tests
Intervention groups
1
Description
Neurotec (capsules containing 120 mg of active gradient) twice a day for 8 weeks
Category
empty
2
Description
Placebo (simillar capsule containing inert substance) twice a day