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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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History
# Registration date Revision Id
2 2024-02-05, 1402/11/16 293817
1 2021-11-30, 1400/09/09 207483
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  • General information

    36
    25
    empty
    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).
    empty
    با توجه به اینکه درطول مطالعه نتایج قابل توجه گروه فرفیون به روشنی دیده شد.آنالیز با 41 نمونه انجام شد و اختلاف شاخصهای آوت کام در دوگروه معنی دار بود.سپس مطالعه با افزودن 20 درصد به تعداد نمونه های قبلی ادامه یافت.و درنهایت با تعداد 50 نمونه آنالیز نهایی صورت پذیرفت.در واقع با توجه به یافتن نتایج معنی دارآماری وبالینی جهت رعایت ملاحظات اخلاقی ضرورتی برای ادامه مطالعه تا رسیدن به تعداد72نمونه(36دارو و36 پلاسبو)دیده نشد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Mazandaran university of Medical Science(Romatology Clinic)
    Name of recruitment center - Persian: درمانگاه روماتولوژی کلینیک ویژه دانشگاه علوم پزشکی مازندران(باغبان)
    Full name of responsible person - English: DR.Mohammad Yousef poor
    Full name of responsible person - Persian: دکتر محمد یوسف پور
    Street address - English: Beginning of Valiasr HighWay,forked Road of Jooybar,Emam Square
    Street address - Persian: میدان امام(ره)سه راه جویبار.ابتدای بزرگراه ولی عصر(عج)
    City - English: sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4815733971
    Phone: +98 11 3304 4000
    Fax: +98 11 3335 2725
    Email: fara_z@yahoo.com
    Web page address:
    Name of recruitment center - English: Bagban Romatology Clinic(TOOBA)Mazandaran university of Medical Science
    Name of recruitment center - Persian: درمانگاه روماتولوژی کلینیک ویژه دانشگاه علوم پزشکی مازندران باغبان(طوبی)
    Full name of responsible person - English: DR.Mohammad Yousef poor
    Full name of responsible person - Persian: دکتر محمد یوسف پور
    Street address - English: Beginning of Valiasr HighWay,forked Road of Jooybar,Emam Square
    Street address - Persian: میدان امام(ره)سه راه جویبار.ابتدای بزرگراه ولی عصر(عج)
    City - English: sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4815733971
    Phone: +98 11 3304 4000
    Fax: +98 11 3335 2725
    Email: fara_z@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: ِِDr.Mohammad yousofPoor
    Full name of responsible person - Persian: دکتر محمدیوسف پور
    Street address - English: Begining of Valiasr Highway_Jooybar Forked road_Emam Square
    Street address - Persian: میدان امام(ره)سه راه جویبار_ابتدای بزرگراه ولی عصر(عج)
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4815733971
    Phone: +98 11 3304 4000
    Fax:
    Email: m.yousofoor@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Majid Saeedi
    Full name of responsible person - Persian: دکتر مجیدسعیدی
    Street address - English: Begining of Valiasr Highway_Jooybar Forked road_Emam Square
    Street address - Persian: میدان امام(ره)سه راه جویبار_ابتدای بزرگراه ولی عصر(عج)
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4815733971
    Phone: +98 11 3448 4800
    Fax:
    Email: majsaeedi@gmail.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Incubation Center for Pharmaceutical Technologies(SBMU)
    Name of organization / entity - Persian: مرکز رشد فن آوریهای دارویی دانشگاه علوم پزشکی شهیدبهشتی
    Full name of responsible person - English: Dr.Faranak Zaker
    Full name of responsible person - Persian: دکتر فرانک ذاکر
    Position - English: Manager and Consultant
    Position - Persian: مدیر مسئول ومشاور
    Latest degree: med_doctor
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 18_yas complex_Bahar Alley_North Shahin_Jannat abad
    Street address - Persian: جنت آباد_شاهین شمالی_کوچه بهار_مجتمع یاس_واحد18
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1475895843
    Phone: +98 21 4443 4912
    Mobile: +98 912 354 4816
    Fax:
    Email: fara_zk@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Danesh Pazhuhan Adonis Group(DPAG)
    Name of organization / entity - Persian: شرکت دانش پژوهان آدونیس
    Full name of responsible person - English: Dr.Faranak Zaker
    Full name of responsible person - Persian: دکتر فرانک ذاکر
    Position - English: Manager and Consultant
    Position - Persian: مدیر مسئول ومشاور
    Latest degree: med_doctor
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 18_yas complex_Bahar Alley_North Shahin_Jannat abad
    Street address - Persian: جنت آباد_شاهین شمالی_کوچه بهار_مجتمع یاس_واحد18
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1475895843
    Phone: +98 21 4443 4912
    Mobile: +98 912 354 4816
    Fax:
    Email: fara_zk@yahoo.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Incubation Center for Pharmaceutical Technologies(SBMU)
    Name of organization / entity - Persian: مرکز رشد فن آوریهای دارویی دانشگاه علوم پزشکی شهیدبهشتی
    Full name of responsible person - English: Dr.Faranak Zaker
    Full name of responsible person - Persian: دکتر فرانک ذاکر
    Position - English: Manager and Consultant
    Position - Persian: مدیر مسئول و مشاور
    Latest degree: med_doctor
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 18_Yas Complex_Bahar Alley_North Shahin_Jannat Abad
    Street address - Persian: جنت آباد_شاهین شمالی_کوچه بهار_مجتمع یاس_واحد18
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1475895843
    Phone: +98 21 4443 4912
    Mobile: +98 912 354 4816
    Fax:
    Email: fara_zk@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Danesh Pazhuhan Adonis Group(DPAG)
    Name of organization / entity - Persian: شرکت دانش پژوهان آدونیس
    Full name of responsible person - English: Dr.Faranak Zaker
    Full name of responsible person - Persian: دکتر فرانک ذاکر
    Position - English: Manager and Consultant
    Position - Persian: مدیر مسئول و مشاور
    Latest degree: med_doctor
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 18_Yas Complex_Bahar Alley_North Shahin_Jannat Abad
    Street address - Persian: جنت آباد_شاهین شمالی_کوچه بهار_مجتمع یاس_واحد18
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1475895843
    Phone: +98 21 4443 4912
    Mobile: +98 912 354 4816
    Fax:
    Email: fara_zk@yahoo.com
    Web page address:

  • Sharing plan

    Dr.Mohammad Yousofpoor(MAZUMS) m.yousofpoor@yahoo.com 00981133243117 Dr.Faranak Zaker(ICPT_SBMU) fara_zk@yahoo.com 00982144434912
    Dr.Mohammad Yousofpoor(MAZUMS) m.yousofpoor@yahoo.com 00981133243117 Dr.Faranak Zaker_Danesh Pazhuhan Adonis Group(DPAG) fara_zk@yahoo.com 00982144434912
    دکتر محمد یوسف پور_دانشگاه علوم پزشکی مازندران m.yousofpoor@yahoo.com 00981133243117 دکتر فرانک ذاکر_مرکز رشد فناوریهای دارویی_دانشگاه علوم پزشکی شهید بهشتی fara_zk@yahoo.com 00982144434912
    دکتر محمد یوسف پور_دانشگاه علوم پزشکی مازندران m.yousofpoor@yahoo.com 00981133243117 دکتر فرانک ذاکر_شرکت دانش پژوهان آدونیس fara_zk@yahoo.com 00982144434912
    connection with DANESH PAGHOOHAN ADONIS.Dr Faranak Zaker Connection with Mazandaran University of Medical Science.Dr Mohhamad Yousofpoor approximately one month after publication
    connection with DANESH PAZHOOHAN ADONIS.Dr Faranak Zaker Connection with Mazandaran University of Medical Science.Dr Mohhamad Yousofpoor approximately one month after publication

Protocol summary

Study aim
Study of Antiinflamatory ,and Analgesic effects of Farfioun Ointment(EUPHORBIA MACROCLADA)on patients with Osteoarthritis
Design
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.
Settings and conduct
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)
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Severity of pain; Rigidity of joint; physical disability.

General information

Reason for update
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).
Acronym
IRCT registration information
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
Registration date
2021-11-30, 1400/09/09
Registrant information
Name
Faranak Zaker
Name of organization / entity
Incubation center for pharmaceutical technologies,Shaheed Beheshti Medical university
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0110
Email address
fara_zk@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-04, 1400/09/13
Expected recruitment end date
2022-02-02, 1400/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical ointment prepared from Euphorbia macroclada Boiss on the clinical symptoms of primary knee osteoarthritis
Public title
Farfioun Effects on Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Beginning of Valie Asr HighWay, Forked Road Of Jooybar, Emam Square, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-10-09, 1400/07/17
Ethics committee reference number
IR.MAZUMS.REC.1400.483

Health conditions studied

1

Description of health condition studied
Early chronic osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Dِecrease in Joint pain
Timepoint
0_14-28
Method of measurement
WOMAC standard questionnaire

Secondary outcomes

1

Description
Rigidity of Joints
Timepoint
0_14_28
Method of measurement
WOMAC

2

Description
Phisical Disability
Timepoint
0-14-28
Method of measurement
WOMAC

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bagban Romatology Clinic(TOOBA)Mazandaran university of Medical Science
Full name of responsible person
DR.Mohammad Yousef poor
Street address
Beginning of Valiasr HighWay,forked Road of Jooybar,Emam Square
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
fara_z@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Majid Saeedi
Street address
Begining of Valiasr Highway_Jooybar Forked road_Emam Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4800
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Mohammad YoosefPoor
Position
Iranian Medical Manager
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medical ,Bagban specific Clinic,khazar BLV
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 3117
Email
m.yousofpoor@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Danesh Pazhuhan Adonis Group(DPAG)
Full name of responsible person
Dr.Faranak Zaker
Position
Manager and Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
18_yas complex_Bahar Alley_North Shahin_Jannat abad
City
Tehran
Province
Tehran
Postal code
1475895843
Phone
+98 21 4443 4912
Email
fara_zk@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Danesh Pazhuhan Adonis Group(DPAG)
Full name of responsible person
Dr.Faranak Zaker
Position
Manager and Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
18_Yas Complex_Bahar Alley_North Shahin_Jannat Abad
City
Tehran
Province
Tehran
Postal code
1475895843
Phone
+98 21 4443 4912
Email
fara_zk@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on primary outcomes and, if created, data on secondary outcomes
When the data will become available and for how long
6 months after printing of results
To whom data/document is available
Researchers Producers
Under which criteria data/document could be used
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.
From where data/document is obtainable
Dr.Mohammad Yousofpoor(MAZUMS) m.yousofpoor@yahoo.com 00981133243117 Dr.Faranak Zaker_Danesh Pazhuhan Adonis Group(DPAG) fara_zk@yahoo.com 00982144434912
What processes are involved for a request to access data/document
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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