1.Determine the mean pain in standard group for 14 days
2.Determine the mean pain in fenugreek group for 14 day
3.Comparison of pain score in both groups
4.Comparison of pain relief in both groups
5.Comparison of drug side effects between the two groups on the 28th day
Design
Two arm parallel group, randomized trial and blinded outcome assessment
Settings and conduct
This study will be performed in Oral and Dental department of Kerman University of Medical Sciences. only researchers are not blinded in this study.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1.Men and women over than 14 year old
2.Patients who are able to answer Questionnaire forms
3.Patients who want to enter the study
exclusion criteria:
1.Pregnancy and Lactation in women
2.diabetic patients
3.Digestive disorders
4.Patient who takes statin
5.The patients who have allergic reaction to fenugreek
6.Patients with history of coagulation disorders
Intervention groups
Capsules containing fenugreek seed extract tablets are given as two 600 mg capsules daily and positive control group will be received capsule containing 500 mg naperoxen twice a day because of long duration of an action and low risk of cardiovascular disease
Main outcome variables
Evaluation of chronic pain relief in patients for 14 days by using VAS questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181218042039N1
Registration date:2019-04-27, 1398/02/07
Registration timing:registered_while_recruiting
Last update:2019-04-27, 1398/02/07
Update count:0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Sara Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 1249
Email address
sara96hashemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-07-01, 1398/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the slow release fenugreek (Trigonella foenum-graecum ) seed formulation on pain relief in patients with temporomandibular disorder
Public title
fenugreek extract effect on pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women over 14 years of age
Patients who be able to respond to the mentioned forms
Patients wishing to enter the study
Exclusion criteria:
Pregnancy and lactation in women
Patients with Diabetes Mellitus
patients who take statin drugs
Sensitivity to Fenugreek or other herbs
Patients with history of coagulation disorders
Patients undergoing orthodontic or orthopedic procedures
Patients treated with anti psychotropic, anti-inflammatory and analgesic drugs and splint therapy
Patients with dental caries that imitate pain in the head and face
Patients with periodontal problems
Patients with pathologic problems in the head and face
Age
From 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the studied and the standard drug in dosage form and packaging are quite similar. Each label has A or B letter that is known by investigator which letter belong to the studied or standard drug.Each patient receives only one arbitration package. After explaining the study process, the patients will be told that the chance of being in each group will be one second and after signing the consent form, with full knowledge of the research process, they will be included in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Deputy of research and technology, Student research committee, Tahmasebad acrossroads, beginning at Ibn Sina street
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.KMU.REC.1397.355
Health conditions studied
1
Description of health condition studied
Temporomandibular disorders
ICD-10 code
M26.60
ICD-10 code description
Temporomandibular joint disorder, unspecified
Primary outcomes
1
Description
reduce pain in Visual Analogue Scale and Brief Pain Inventory questionnaire
Timepoint
at beginning of the study and after 14th , 28th days of the beginning of the study
Method of measurement
Visual Analogue Scale and Brief Pain Inventory of pain questionnaire
Secondary outcomes
1
Description
GI upset
Timepoint
Two and four weeks after drug administration
Method of measurement
Patient claim and Questionnaire fullfilment
Intervention groups
1
Description
Intervention group: Fenugreek seed extract, with amount of 600 mg in each capsule, twice a day, in two weeks, once every 12 hours, after meal
Category
Treatment - Drugs
2
Description
Control group: naproxen capsules, with amount of 500 mg in each same capsules, twice a day, in two weeks, once every 12 hours, after meal, Pars darou company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Goli Ghamani and Reza Zarei
Street address
Faculty of Dentistry, end of Shafa Boulevard, Kerman, Kerman Province
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 9021
Fax
+98 34 3211 8073
Email
dentistryschool@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/sd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Kerman University of Medical Sciences, Deputy of research and technology, Student research committee, Tahmasebi acrossroads, beginning at Ibn Sina street
City
Kerman
Province
Kerman
Postal code
761981555
Phone
+98 34 3226 3855
Fax
+98 34 3226 3855
Email
research@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
761913555
Phone
+98 34 3132 5022
Fax
+98 34 3132 5003
Email
mansari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5022
Fax
+98 34 3132 5003
Email
mansari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
761913555
Phone
+98 34 3132 5022
Fax
+98 34 3132 5003
Email
mansari@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The results may show effectiveness of the drug, therefor we want to make patent.