Comparative study of diclofenac and vitamin E, vitamin E alone and meloxicam and vitamin E in reducing pain in patients with mastalgia: randomized, double-blind clinical trial
A comparative study of diclofenac and vitamin E, vitamin E alone and meloxicam and vitamin E in reducing pain in patients with mastalgia: a double-blind randomized clinical trial
Design
Patients are randomly divided into three categories. The first group (vitamin E and diclofenac) should take one chewable 200 mg vitamin E tablet daily and two 25 mg diclofenac tablets. (68) In the second group (vitamin E alone), an oral chewable tablet of vitamin E at a dose of 200 mg daily, and the third group will take (vitamin E and meloxicam) an oral chewable tablet of vitamin E at a dose of 200 mg daily. Mg and meloxicam 15 mg daily for four months. Then every two weeks patients should be evaluated for pain intensity. After the doctor prescribes these drugs, another person who does not know the type of drugs prescribed, asks the patient about pain information by phone and records it in a questionnaire. The duration and severity of pain will be assessed by the VAS char.
Settings and conduct
This study is a clinical trial that after obtaining consent, patients referred to Khatam Al-Anbia and Honari clinic Comprehensive Cancer Center (PBUH) Peymaniyeh Hospital in Jahrom with mastalgia symptoms are randomly divided into three groups of 3/3. , The patient becomes blind ..
Participants/Inclusion and exclusion criteria
inclusion criteria:
age over 18 years, the onset of pain at least 3 months ago, absence of pathological lesions such as cancer, cysts, etc.
Intervention groups
The first group will take (vitamin E and diclofenac) for 4 months
the second group will take (vitamin E alone), for 4 months
and the third group will take (vitamin E and meloxicam) for 4 months.
Main outcome variables
Patient pain after consumption
Vitamin E and diclofenac
Vitamin E alone
Vitamin E and Moluxkiam
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210215050371N1
Registration date:2023-06-24, 1402/04/03
Registration timing:registered_while_recruiting
Last update:2023-06-24, 1402/04/03
Update count:0
Registration date
2023-06-24, 1402/04/03
Registrant information
Name
ahmadreza bazmjoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 2414
Email address
ahmadreza1233@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-12-30, 1403/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of diclofenac and vitamin E, vitamin E alone and meloxicam and vitamin E in reducing pain in patients with mastalgia: randomized, double-blind clinical trial
Public title
Comparative study of diclofenac and vitamin E, vitamin E alone and meloxicam and vitamin E in reducing pain in patients with mastalgia: randomized, double-blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years old or above, pain started at least 3 months ago,
Exclusion criteria:
Pathologic mass like cycst,cancer etc...
Failure to enter: lack of consent of the patient to participate in the study. End-stage diseases such as cancer, kidney failure, heart failure
Age
From 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be taken by simple random sampling. Then each member of the sample will be randomly assigned to one of the 4 subgroups:1-diclofenac 2- diclofenac and vitamin E, 3-vitamin E alone 4-meloxicam and vitamin E with computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of jahrom University of Medical Sciences
Street address
Ostad Motahari blvd , Jahrom city, Fars province, Iran
City
jahrom
Province
Fars
Postal code
Approval date
2021-01-10, 1399/10/21
Ethics committee reference number
IR.JUMS.REC.1399.107
Health conditions studied
1
Description of health condition studied
mastalgia
ICD-10 code
N64.4
ICD-10 code description
Mastodynia is the medical term describing the common symptom of breast pain
Primary outcomes
1
Description
Mastalgia
Timepoint
The intensity of the patient's pain is measured at the beginning of the study and then evaluated daily after the start of the treatment.
Method of measurement
Visual analog scale and breast pain chart
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group :Vitamin E and diclofenac) should take a simple oral chewable vitamin E tablet of 200 mg daily and two diclofenac 25 mg tablets daily.
Category
Treatment - Drugs
2
Description
Intervention group: The second group (vitamin E alone), a simple and oral chewable tablet of vitamin E at a dose of 200 mg (based on previous research in this field) for 4 months
Category
Treatment - Drugs
3
Description
Intervention group: The third group (vitamin E and meloxicam) should be given a simple oral chewable tablet of this vitamin with a dose of 200 mg and meloxicam 15 mg daily for four months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom EmamReza clinic
Full name of responsible person
Dr. Marzie Haghbin
Street address
Valiye Asr Ave, Jahrom city , Fars province
City
Jahrom
Province
Fars
Postal code
74198 86688
Phone
+98 71 5423 0011
Email
ahmadreza1233@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr Solhjoo
Street address
Motahari
City
Jahrom
Province
Fars
Postal code
7461419867
Phone
+98 991 043 8952
Email
ahmadreza1233@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
ahmadreza bazmjoo
Position
Med student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Biology
Street address
ِDaneshpoor Ave, Motahrai Ave ,Jahrom city, Fars province
City
Jahrom
Province
Fars
Postal code
7461419867
Phone
+98 991 043 8952
Email
ahmadreza1233@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
ahmadreza bazmjoo
Position
Med student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Biology
Street address
ِDaneshpoor Ave, Motahrai Ave ,Jahrom city , Fars province
City
Jahrom
Province
Fars
Postal code
7461419867
Phone
+98 991 043 8952
Email
ahmadreza1233@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
ahmadreza bazmjoo
Position
Med student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Biology
Street address
ِDaneshpoor Ave, Motahrai Ave ,Jahrom city , Fars province
City
Jahrom
Province
Fars
Postal code
7461419867
Phone
+98 991 043 8952
Email
ahmadreza1233@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available