Evaluation of the efficacy and safety of Glycyrrhiza glabra and zingiber officinale in controlling pain symptoms in patients after Total Knee Arthroplasty(TKA)
Overall Objective: To evaluate the function and improve pain in patients after TKA surgery and provide appropriate oral treatment with fewer side effects and better performance than conventional NSAIDs.
Minor goals:
1- Comparing the effect of licorice and ginger combination with diclofenac drug in controlling patients' pain after زomplete knee replacement based on VAS.
2- Comparison of the effect of licorice and ginger combination with diclofenac on inflammatory indicators (IL-6 and TNF-α) in patients after knee replacement surgery.
3- Comparison of the effect of licorice and ginger combination with diclofenac drug on patients' quality of life after complete knee replacement based on cop
Design
Randomised, superiority, parallel group trial with blinded outcome assessment.The rand function of the Excel software was used for randomization.
Settings and conduct
The study will be performed at Baqiyatallah Hospital. We will use Excel software and rand function to prepare random arrangements. The created files will be stored with the study epidemiologist during the production process of the random chain and its results.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Patients who are candidates for complete joint replacement will be examined after surgery and discharge from the hospital.
2) informed consent form will be completed by the patient or the patient's supervisor to participate in the study.
Exclusion criteria:
1) Inflammatory underlying disease such as rheumatoid arthritis
2) Drug addiction
3) Smoking
Intervention groups
Both groups will receive diclofenac medication.The intervention group will receive 500 mg of licorice and ginger herbal composition every 12 hours for 8 weeks, and the placebo group 500 mg herbal every 12 hours .
Main outcome variables
Pain relief
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N62
Registration date:2020-07-02, 1399/04/12
Registration timing:prospective
Last update:2020-07-02, 1399/04/12
Update count:0
Registration date
2020-07-02, 1399/04/12
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of Glycyrrhiza glabra and zingiber officinale in controlling pain symptoms in patients after Total Knee Arthroplasty(TKA)
Public title
The effect of licorice and ginger herbal composition on controlling patients' pain symptoms after knee joint replacement surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are candidates for complete knee replacement after surgery and hospital discharge
Exclusion criteria:
Inflammatory underlying disease such as rheumatoid arthritis
Drug addiction
smoking
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Block Randomization method will be used using four and six blocks with random order. We will use Excel software and rand function to prepare random arrangements. The created files will be stored with the study epidemiologist during the production process of the random chain and its results.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Concealment
A four-digit numeric code will be assigned to each of the random loop loops.
The chain is generated centrally through a responsible person using a phone call or through a website
The Interactive Web Response System will be dedicated to the study centers. In this way, each of the centers will be given one or more usernames and passwords to enter the website through it. Upon arrival, the patient will receive the initial information and then, to ensure that he or she has the consent and the conditions to enter the study, the randomization code will be assigned to him / her based on a predetermined random chain.
Blinding
This is a triple blind study and a placebo drug was designed for it, which is completely compatible with the body in terms of safety and has no side effects.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Comparison of the effect of different doses of licorice and ginger herbal composition in one group and diclofenac drug in the second group
Timepoint
Before the intervention, and 8, 12 and 24 hours after consuming the herbal combination, licorice and ginger, every 12 hours to 8 weeks
Method of measurement
The pain VAS is a unidimensional measure of pain intensity
Secondary outcomes
1
Description
post-intervention Quality of life score
Timepoint
Up to 28 weeks after the intervention
Method of measurement
It will be measured according to the Cop Corn questionnaire
Intervention groups
1
Description
Intervention group:They will receive a diclofenac treatment (75 mg daily) one hour after meals daily. Furthermore, the herbal combination of licorice and ginger ( capsules 500 mg) will be prescribed every 12 hours for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: They will receive a diclofenac treatment (75 mg daily) one hour after meals daily. Also, 500 mg of plasbo capsule will be prescribed every 12 hours for 8 weeks
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
Yes - There is 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
Participants' data files, study protocol, statistical analysis map, statistical analysis, clinical study report and classification system will be shared. However, after making people unrecognizable, part of the data, such as information about the main consequence or the like, can be shared one hundred percent.
When the data will become available and for how long
The access period will start 6 months after publication
To whom data/document is available
Data will only be available to researchers working at academic and scientific institutions
Under which criteria data/document could be used
After publishing the data and the article, any kind of analysis is allowed by mentioning the source
From where data/document is obtainable
Sheikh Bahaie South Street, Mulla Sadra Street, Vanak Square, Tehran, IRAN.School of Pharmacy
What processes are involved for a request to access data/document
After the communication is established, the applicant must submit a written request to the relevant organization and the request will be answered within 4-5 months