Investigating the Effect of Hypericum perforatum (Perforan) Tablets on Neurological Pain, Functional Independence and Severity of Depression in Patients with Spinal Cord Injuries
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Primary outcomes
#1
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Spinal Cord Independence Measure
Spinal Cord Independence Measure
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استقلال عملکردی ضایعه نخاعی
استقلال عملکردی ضایعه نخاعی
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Before the start of the intervention and 21 days after the start of treatment
Before the start of the intervention and 21 days after the start of treatment
Name of recruitment center - English: Rofaydeh Rehabilitation Center
Name of recruitment center - Persian: بیمارستان توانبخشی رفیده
Full name of responsible person - English: Seyed Majid Akhavan Hejazi
Full name of responsible person - Persian: سید مجید اخوان حجازی
Street address - English: Rofaydeh Rehabilitation Center, Shahid Nemati St., Southern Salimi Ave.
Street address - Persian: خیابان سلیمی جنوبی، کوچه شهید نعمتی، بیمارستان توانبخشی رفیده
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1935973476
Phone:
Fax:
Email: dr.majid.hejazi@gmail.com
Web page address:
Name of recruitment center - English: Rofaydeh Rehabilitation Center
Name of recruitment center - Persian: بیمارستان توانبخشی رفیده
Full name of responsible person - English: Seyed Majid Akhavan Hejazi
Full name of responsible person - Persian: سید مجید اخوان حجازی
Street address - English: Rofaydeh Rehabilitation Center, Shahid Nemati St., Southern Salimi Ave.
Street address - Persian: خیابان سلیمی جنوبی، کوچه شهید نعمتی، بیمارستان توانبخشی رفیده
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1935973476
Phone: +98 21 23570
Fax:
Email: dr.majid.hejazi@gmail.com
Web page address:
Name of recruitment center - English: Rofaydeh Rehabilitation Center Name of recruitment center - Persian: بیمارستان توانبخشی رفیده Full name of responsible person - English: Seyed Majid Akhavan Hejazi Full name of responsible person - Persian: سید مجید اخوان حجازی Street address - English: Rofaydeh Rehabilitation Center, Shahid Nemati St., Southern Salimi Ave. Street address - Persian: خیابان سلیمی جنوبی، کوچه شهید نعمتی، بیمارستان توانبخشی رفیده City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1935973476 Phone: +98 21 23570 Fax: Email: dr.majid.hejazi@gmail.com Web page address:
Protocol summary
Study aim
Determining the effect of Hypericum perforatum tablets (Perforan drug produced by Gol Daru Company) on neurological pain, functional independence, and depression severity in patients with spinal cord injury in the subacute phase
Design
A controlled, parallel-group, randomized, phase 0 clinical trial on 30 patients. The randomizer.org website was used for randomization.
Settings and conduct
The study site is Rofaideh Rehabilitation Hospital, Tehran, Iran. Patients hospitalized in the spinal cord injury ward with stable condition are used for rehabilitation and subacute phase treatments. Completing the consent form, random assignment to two control and treatment groups (simple randomization), and prescribing Perforan tablets for a 21-day period are the steps of the study. The severity of spinal cord injury is assessed using the ASIA scale and a demographic questionnaire is completed at the beginning of the study. Neurological pain severity, patient functional independence score, and Beck depression test are assessed at the beginning and end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Sub-acute phase
Exclusion criteria: Intolerance or adverse laboratory changes, drug interactions
Intervention groups
Intervention group: Perforan tablets from Gol Daru Company, licensed by the Food and Drug Administration of Iran, 3 times a day, one tablet each time. Control group: Without receiving a placebo
Investigating the Effect of Hypericum perforatum (Perforan) Tablets on Neurological Pain, Functional Independence and Severity of Depression in Patients with Spinal Cord Injuries
Public title
Study the Effect Hypericum perforatum medicine on spinal cord injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Full consent to participate in the study
At least one month has passed from the lesion and the patient is in the sub-acute phase
Exclusion criteria:
Acute and chronic phases of spinal cord injury
Intolerance, allergic reaction or unexpected laboratory changes identified by the patient or specialist physician
Medications that may interact with Perforan tablets (Such as cytochrome P450 inducers, SSRI and MAOI drugs, blood pressure lowering drugs, anticoagulant drugs)
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: The allocation of individuals to groups is done in the form of a four-block random allocation. First, the size of each block is specified (four-block), then the list of blocks is specified with the help of the randomizer.org website and numbers are assigned to them (numbers 1 to 15 for 60 people), and each of the numbers on the list is placed in an envelope for its own treatment allocation. Then, individuals entering the study randomly select envelopes containing numbers between one and 15, and the allocation of individuals to two groups, 1 and 2, is determined based on a list of blocks of four for each number
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad Tehran Medical Science University Pharmacy and Pharmaceut
Street address
Tehran Medical Sciences of Islamic Azad Uninversity, Gole-Yakh Ave., Ayeneh Blv., Amir Pabarja Ave., Dr. Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2024-11-12, 1403/08/22
Ethics committee reference number
IR.IAU.PS.REC.1403.474
Health conditions studied
1
Description of health condition studied
Spinal Cord Injury
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Neurological Pain
Timepoint
Before the start of the intervention and 21 days after the start of treatment
Method of measurement
Numeric Rating Scale
2
Description
Functional Independence
Timepoint
Before the start of the intervention and 21 days after the start of treatment
Intervention group: Perforan tablets (Hypericum perforatum), Gol Daru Company. It has a license from the Food and Drug Administration, one tablet 3 times a day.
Category
Rehabilitation
2
Description
Control group: No placebo
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofaydeh Rehabilitation Center
Full name of responsible person
Seyed Majid Akhavan Hejazi
Street address
Rofaydeh Rehabilitation Center, Shahid Nemati St., Southern Salimi Ave.
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 23570
Email
dr.majid.hejazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud parsania
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Ayeneh Blv.,Pabarja St., Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2264 0599
Email
mparsania@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mansooreh Sadat Mojani Qomi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Pharmacy, Yakhchal St., Dr. Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
mansooreh.moujani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mansooreh Sadat Mojani Qomi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Pharmacy, Yakhchal St., Dr. Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
mansooreh.moujani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mansooreh Sadat Mojani Qomi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Pharmacy, Yakhchal St., Dr. Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
mansooreh.moujani@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data about the main outcome or similar can be shared.
When the data will become available and for how long
After publication the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
To write a meta-analysis
From where data/document is obtainable
Mansooreh Sadat Mojani Qomi through sending email to mansooreh.moujani@gmail.com
What processes are involved for a request to access data/document
Up to about one month after application if results are published