Evaluation of the effectiveness of herbal topical products (Cymbopogon schoenanthus and Anethum graveolens dhi) on knee pain and function in patients with knee osteoarthritis
Evaluation of the effectiveness of herbal topical products (Cymbopogon Schoenanthus and Anethum graveolens on knee pain and function in patients with knee osteoarthritis
Design
Clinical trial, having three parallel groups (two case groups and one control group), randomized, Phase 2-3, on 150 patients with knee osteoarthritis, was used to randomize the Random Number table.
Settings and conduct
The study has two parts: pharmaceutical and clinical trials. The medicine supply department (during the years 2022-2023) was carried out in the laboratory of traditional medicine of the Army University of Medical Sciences and the clinical trial department will be carried out in the Orthopedic Clinic of the 501 Aja hospital. In addition to receiving the study intervention, patients will receive common treatments (use of Acetaminophen (PRN - up to 2 mg per day), life style Modification, weight correction, physiotherapy and muscle strengthening).
Participants/Inclusion and exclusion criteria
People with knee osteoarthritis
Ages 40 to 65
No history of inflammatory and joint diseases
No history of knee fractures and their surroundings
No history of trauma to the knee.
No history of ligamental injury
No history of knee infections
Intervention groups
The Group receiving Cymbopogon Schoenanthus gel (First case group)
The Group receiving Anethum graveolens gel (Second case group)
The Group receiving piroxicam gel (control group)
Main outcome variables
Pain assessment: Visual analogue scale (VAS)
Function assessment: WOMAC questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221009056125N1
Registration date:2024-05-04, 1403/02/15
Registration timing:prospective
Last update:2024-05-04, 1403/02/15
Update count:0
Registration date
2024-05-04, 1403/02/15
Registrant information
Name
Mohammad Raisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3438 2357
Email address
mohammadraisi7394@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of herbal topical products (Cymbopogon schoenanthus and Anethum graveolens dhi) on knee pain and function in patients with knee osteoarthritis
Public title
Evaluation of the effectiveness of topical gel (Cymbopogon schoenanthus and Anethum graveolens dhi) in osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with knee Osteoarthritis Grade I and II
Exclusion criteria:
History of knee trauma
History of joint degenerative diseases (rheumatoid arthritis and ...)
History of fractures in and around the knee joint
History of knee joint infection
History of ligamental injury
BMI>30
Age
From 40 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Method: simple randomization
Unit: man
Tool: Random Number table
All the gels were in unified tubes with the numbers indicated, which the patient and the evaluating physician did not know about.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, the tubes were filled and labeled by the pharmacist's researcher. After the doctor's assessment and the patient's entry into the study, the consolidated tubes were given to the patient by the researcher based on the patient's position in the groups, thus keeping the doctor and the patient blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of AJA University of Medical Sciences
Street address
Shahid Etemad Zadeh St, West Fatemi St
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2023-02-19, 1401/11/30
Ethics committee reference number
IR.AJAUMS.REC.1401.194
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Severity of knee pain
Timepoint
Before the start of the intervention, two weeks and four weeks after the start of the intervention
Method of measurement
Visual Analogue Scale
2
Description
function of knee
Timepoint
Before the start of the intervention, two weeks and four weeks after the start of the intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis Index
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: recipient of Cymbopogon Schoenanthus gel (ethanol extract 0.5%), up to a month every night, in the amount (2cc), taken topically
Category
Treatment - Drugs
2
Description
Second intervention group: recipient of Anethum graveolens gel (ethanol extract 0.5%), up to a month every night, in the amount (2cc), taken topically
Category
Treatment - Drugs
3
Description
Control group: recipient of the piroxicam topical gel 0.5%, up to a month every night, in the amount of 2 CC, topically, Daro Pakhsh company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic clinic, 501 Aja hospital
Full name of responsible person
Mohammad Raisi
Street address
Shahid Etemad Zadeh St,West Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 913 392 9639
Fax
Email
MohammadRaisi7394@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Raisi
Street address
Shahid Etemad Zadeh St, West Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 913 392 9639
Email
Mohammadraisi7394@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Raisi
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Taleghani Ave.
City
Anar
Province
Kerman
Postal code
7741664414
Phone
+98 34 3438 2357
Fax
Email
mohammadraisi7394@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Raisi
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Taleghani Ave.
City
Anar
Province
Kerman
Postal code
7741664414
Phone
+98 34 3438 2357
Fax
Email
mohammadraisi7394@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Raisi
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Taleghani Ave.
City
Anar
Province
Kerman
Postal code
7741664414
Phone
+98 34 3438 2357
Fax
Email
mohammadraisi7394@gmail.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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
will published
When the data will become available and for how long
Start of access period 6 months after releasing results
To whom data/document is available
all researchers
Under which criteria data/document could be used
There are no specific conditions.
From where data/document is obtainable
referred to RCT Manager
What processes are involved for a request to access data/document
After the applicant is checked, the data will be available to him for a maximum of one month.