Effect of Terminalia chebula gel in reducing the pain of patients with knee osteoarthritis: triple-blind randomized clinical trial

Determining the effect of Black Helilah gel in reducing the pain of patients with knee osteoarthritis

First, after the confirmation of the scientific name, the fruit of the Black Helilah plant is extracted by the maceration method, and the preparation of the gel formulation will be done by a pharmacognosist. In this three-blind clinical trial, after receiving the permission of the ethics committee and informed consent, 78 patients with knee osteoarthritis were selected and randomly divided into 3 groups of 26 people. The first group took placebo gel 3 times a day, the second group took 5% Black Helilah topical gel 3 times a day, and the third group took 1% diclofenac topical gel 3 times a day.

Our study population is patients with knee osteoarthritis in the age group of 45-75 years old, referring to the teaching clinic of Shahrekord University of Medical Sciences.

Entry: age range of 45-75 years and definite diagnosis of osteoarthritis based on diagnostic criteria by a specialist doctor Non-entry: absence of simultaneous severe diseases such as metabolic and gastrointestinal diseases, absence of severe infection, absence of pregnancy and breastfeeding and disturbed liver tests, absence of history of old fracture or knee surgery, absence of rheumatoid arthritis and seronegative and seropositive arthropathies, absence of history Intra-articular injection within the last 6 weeks

78 patients with knee osteoarthritis were selected and randomly divided into 3 groups of 26 people. The first group consumes placebo gel 3 times a day, the second group consumes 5% Black Halila topical gel 3 times a day, and the third group consumes 1% diclofenac topical gel 3 times a day.

Reducing knee pain and stiffness and improving quality of life in patients with osteoarthritis

The random unit The random unit will be an individual participant. Each participant is randomly assigned to one of the two groups of intervention (Black Haliley gel) or control group (placebo gel). Layered randomization In layered randomization, participants are layered based on key variables such as age, gender and primary pain in order to ensure balanced distribution among therapeutic groups. For example, layers are defined by age groups (less than 5 years, 2 years and older), gender (male, female) and primary pain (low, medium, severe). The random sequence of random numbers generated by the computer will be used. This sequence is produced using statistical software such as SPSS, R or SAS to ensure randomness in randomization if the individual is observed, the individual is entered into the intervention group and if the number is even, the control group is entered into the control group. Allocation Concealment: The study coordinator delivers the relevant gel to the participant after completing the initial evaluation of the participant and confirming his or her qualification to participate in the study, and reviewing the allocated treatment group (intervention/ control).

The samples prepared by the pharmacognosist colleague are packed in tubes marked with A, B and C so that the researcher, the patient and the statistician of the project are not aware of the content of the three types of tubes A, B and C.

To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.

The access period will start 6 months after the results are published.

Our data will only be available to researchers working in academic and scientific institutions.

If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data.

In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address navid.1999@yahoo.com or the contact number 00989103259963.

To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.