Protocol summary
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Study aim
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Study of Antiinflamatory ,and Analgesic effects of Farfioun Ointment(EUPHORBIA MACROCLADA)on patients with Osteoarthritis
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Design
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Assignment of patients to two treatment groups is done by random blocking method, and the obtained sequence is written by one of the colleagues in separate sheets and placed in sealed envelopes, and It will be given to the main researcher to study. In this way, the patient and the evaluating physician and researcher will not know any type of treatment.
Data using SPSS software, ANOVA repeated measure test
, T test and Chi-square will be analyzed.
The sample size is 36 samples.
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Settings and conduct
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Random blocking;
Double Blind Study;
Patient_Physician_Researcher;
Use www.randomization.com and www.randomizer.org to generate sequences;
Special Rheumatology Clinic of Mazandaran University of Medical Sciences _Baghban (Tooba)
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Participants/Inclusion and exclusion criteria
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Entry requirements:
The study population included patients with primary chronic osteoarthritis (grade 1-2);
Patients who have not had a joint replacement;
Patients 40 to 75 years old;
Patients with BMI 26_31.
Exclusion criteria:
Patients with cognitive impairment or psychiatric disorders will not be included in the study.
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Intervention groups
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Patients separated to 2 groups by randomization .One group will take standard medicine+farfioun topical ointment(E.M) and the other group will take standard medicine+plasebo.
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Main outcome variables
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Severity of pain;
Rigidity of joint;
physical disability.
General information
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Reason for update
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Due to the fact that during the study, the remarkable results of the Ferfion group were clearly seen. The analysis was done with 41 samples and the difference of the out come indicators in the two groups was significant. Then the study continued by adding 20% to the number of previous samples. And finally The final analysis was done with the number of 50 samples. In fact, due to finding significant statistical and clinical results, in order to comply with ethical considerations, there was no need to continue the study until reaching the number of 72 samples (36 drugs and 36 placebos).
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210916052501N1
Registration date:
2021-11-30, 1400/09/09
Registration timing:
prospective
Last update:
2024-02-07, 1402/11/18
Update count:
1
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Registration date
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2021-11-30, 1400/09/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-12-04, 1400/09/13
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Expected recruitment end date
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2022-02-02, 1400/11/13
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of topical ointment prepared from Euphorbia macroclada Boiss on the clinical symptoms of primary knee osteoarthritis
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Public title
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Farfioun Effects on Osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients that their Early chronic osteoarthritis are confirmed by romatologist based on Kellgren_Lawrence criteria
Early Chronic Osteoarthritis Grade1_2
Exclusion criteria:
Patients with Psychological disorder or Cognitive disorders
Patients with sever chronic disorders like insulin-dependent diabetes, Lupus, Kidney disease and patients with uncontrolled hypertension
Joint pain because of joint replacement
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Age
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From 40 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
25
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random blocking;
Assignment of patients to two treatment groups is done by random blocking method and in order to produce sequences free website www.randomization.com or
randomizer.org is used. The sequence obtained by one of the colleagues is written in separate sheets and placed in sealed envelopes, and then it will be given to the main researcher for studing. In this way, the patient and the evaluating physician, and the researcher will not be awared of any type of treatment.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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participants; Research fellow; Clinical Attentive; The patient and the treating physician, who is responsible for evaluating the patient in terms of response to treatment, and the researcher will not know the type of treatment assigned to the patient (drug or placebo). Equalization of medicated ointment and placebo is required for blinding, the base of medicated ointment and placebo is the same but herbal extract is not used in placebo, so to match medicated ointment and placebo for ointment color, USP Pharmacopoeia colors, and for specific ointment smell, USP Authorized essential oils will be used. ointments are finally coded by the coding system.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-09, 1400/07/17
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Ethics committee reference number
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IR.MAZUMS.REC.1400.483
Health conditions studied
1
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Description of health condition studied
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Early chronic osteoarthritis
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Dِecrease in Joint pain
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Timepoint
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0_14-28
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Method of measurement
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WOMAC standard questionnaire
Secondary outcomes
1
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Description
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Rigidity of Joints
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Timepoint
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0_14_28
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Method of measurement
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WOMAC
2
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Description
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Phisical Disability
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Timepoint
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0-14-28
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Method of measurement
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WOMAC
Intervention groups
1
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Description
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Intervention group:time of intervention is 4 weaks.and pain control test is WOMAC index.and it is used in time 0 ,2 ,4 weak after initiating of terapy.medicine will be used TID ,and a fingertip unit.E.M extract +Eucerin+Antioxidant is used ,in topical ointment. Consume Selexib 100mg BD and omega 3 at a rate of 1 per day.
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Category
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Treatment - Drugs
2
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Description
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Control group: If both knees of the patient are involved, the criterion for evaluation is the knee that has more pain and limitation of movement. However, in order to simulate the color of the ointment, the authorized food colors of Pharmacopea USP will be used. The number of uses is three times a day and each time it is the amount of a finger The duration of use is up to 4 weeks continuously. Consume Selexib 100mg BD and omega 3 at a rate of 1 per day.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data on primary outcomes and, if created, data on secondary outcomes
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When the data will become available and for how long
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6 months after printing of results
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To whom data/document is available
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Researchers
Producers
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Under which criteria data/document could be used
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use of documents in the way of research is acceptable.
commitment on not to use of documents in the way the same research and prodouction that we do.
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From where data/document is obtainable
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Dr.Mohammad Yousofpoor(MAZUMS)
m.yousofpoor@yahoo.com
00981133243117
Dr.Faranak Zaker_Danesh Pazhuhan Adonis Group(DPAG)
fara_zk@yahoo.com
00982144434912
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What processes are involved for a request to access data/document
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connection with DANESH PAZHOOHAN ADONIS.Dr Faranak Zaker
Connection with Mazandaran University of Medical Science.Dr Mohhamad Yousofpoor
approximately one month after publication
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Comments
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