Protocol summary
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Study aim
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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
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Design
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A controlled, parallel-group, randomized, phase 0 clinical trial on 30 patients. The randomizer.org website was used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Sub-acute phase
Exclusion criteria: Intolerance or adverse laboratory changes, drug interactions
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Intervention groups
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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
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Main outcome variables
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Neurological pain; Functional independence score; Depression severity
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20241118063767N1
Registration date:
2024-12-04, 1403/09/14
Registration timing:
prospective
Last update:
2026-01-06, 1404/10/16
Update count:
1
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Registration date
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2024-12-04, 1403/09/14
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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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2025-01-19, 1403/10/30
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Expected recruitment end date
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2025-06-21, 1404/03/31
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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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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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Public title
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Study the Effect Hypericum perforatum medicine on spinal cord injury
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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)
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Age
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No age limit
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Gender
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Both
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Phase
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0
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2024-11-12, 1403/08/22
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Ethics committee reference number
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IR.IAU.PS.REC.1403.474
Health conditions studied
1
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Description of health condition studied
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Spinal Cord Injury
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ICD-10 code
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T09.3
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ICD-10 code description
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Injury of spinal cord, level unspecified
Primary outcomes
1
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Description
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Neurological Pain
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Timepoint
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Before the start of the intervention and 21 days after the start of treatment
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Method of measurement
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Numeric Rating Scale
2
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Description
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Functional Independence
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Timepoint
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Before the start of the intervention and 21 days after the start of treatment
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Method of measurement
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Functional Independence Measure (FIM) Questionnaire
3
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Description
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Depression severity
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Timepoint
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Before the start of the intervention and 21 days after the start of treatment
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Method of measurement
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Beck Depression Inventory
4
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Description
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Spinal Cord Independence Measure
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Timepoint
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Before the start of the intervention and 21 days after the start of treatment
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Method of measurement
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Spinal Cord Independence Measure (SCIM) Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: No placebo
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Category
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N/A
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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Islamic Azad University
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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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Undecided - It is not yet known if there will be 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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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Not applicable
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Data about the main outcome or similar can be shared.
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When the data will become available and for how long
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After publication the results
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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To write a meta-analysis
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From where data/document is obtainable
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Mansooreh Sadat Mojani Qomi through sending email to mansooreh.moujani@gmail.com
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What processes are involved for a request to access data/document
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Up to about one month after application if results are published
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Comments
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