Evaluation the Effect of Coconut Oil as a complementary therapy on fatigue in Covid-19 patients A randomized double-blind pilot study

Determining the effect of coconut oil supplement therapy in improving weakness and reducing the duration of patients with Covid-19

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 28 patients. Random sequence generator software was used for randomization

Patients in Mashhad who are being treated at home with a diagnosis of Covid19 are randomly selected and placed in one of two control or intervention groups. Both groups are treated according to the standard protocol of the Ministry of Health. The intervention group, consumes 30 cc (15 cc every 12 hours) of virgin coconut oil daily in pure form or with milk or soup and The control group receives 30 cc (15 cc every 12 hours) of the placebo solution (pure or with milk or soup) daily. Demographic information, weakness and other symptoms (shortness of breath, cough, fever, sore throat, myalgia, etc.) are recorded by a VAS-based questionnaire at the beginning and one week after treatment by the researcher by phone. They followed up at the end of the second week for symptoms.

Patients aged 18 to 80 years who, according to the information registration system of Mashhad University of Medical Sciences, have been diagnosed with Covid 19 and are under care and treatment at home, Criteria for non-inclusion include: patients with allergies to coconut and its derivatives, severe illness, and need for hospitalization

The intervention and control groups receive routine treatment of the disease. In addition, the intervention group consumed 30 cc (15 cc every 12 hours) of coconut oil daily in their diet orally (pure or with milk or soup). The control group consumes the placebo solution with the same instructions.

Weakness according to VAS criteria

In this study, randomization will be performed by simple randomization method using random numbers derived from Excel program. First, the total sample size and number of groups are entered into the software. The software output includes a list that randomly assigns patients to two groups A (intervention) and B (control). Patients are distributed according to the time of referral according to the list of the mentioned group until the end of sampling. Random sequence generation in Excel software is done using the RANDBETWEEN () function According to this method, each of the cells is randomly assigned a code of 0 or 1. Cells with code 0 belong to the intervention group and cells with code 1 belong to the control group. Patients are assigned to one of the groups according to the generated list.

This study is performed as a double-blind study. The researcher and the patients participating in the study are unaware of the content of the drug. Drugs are prepared and coded in similar packages and provided to the executor for the prescription to patients. The outcome assessment is done by a person who is blind to the allocation process.

Information and data on the primary and secondary outcomes of patients will be shared after being identified.

Ability to access data about 6 months after printing the results

All researchers will be allowed access to the data after reviewing it by the person in charge of the study.

Any analysis of the data will be possible only with the permission of the corresponding author

corresponding Author

The person submits their request, the corresponding author evaluates the accessibility and if possible the access to the data will be granted.