The effect of curcumin and bromelain on anxiety, stress, depression, quality of life and sleep quality in diabetic neuropathy patients.

Determining the effect of curcumin and bromelain on anxiety, stress, depression, quality of life and sleep quality in patients with diabetic neuropathy.

Clinical trial of control group drug, with parallel groups, triple blind, randomized, phase 3 on 100 patients

After receiving the code of ethics and the code of IRCT.The eligible patients will be randomly assigned to the supplement group (combination of curcumin and bromelain) and placebo (lactose). Questionnaires will be completed at the beginning and end of the study and the participants will not stop receiving the standard treatment. Daily intervention group 2 They will receive capsules containing curcumin and bromelain for 8 weeks. The control group will consume the same amount of placebo or lactose. The patient is the therapist and the analyst.

People with diabetic neuropathy in the age range of 40 to 65 years with a BMI in the range of 18.5 to 30 are included in the study. Patients with pineapple allergy, patients with neurological diseases that cause neuropathy, patients who are taking drugs that interfere with treatment such as Nerve drugs such as SSRIs, antidepressants and anti-stress drugs, and non-steroidal anti-inflammatory drugs, or patients who take anticoagulant drugs, patients who have foot ulcers, visual disturbances, and dizziness are not included in the study.

The intervention group will receive 2 capsules containing curcumin and bromelain daily, with a dose of 150 mg of bromelain equivalent to 375 GDU and 300 mg of curcumin per capsule for 8 weeks. The control group will consume the same amount of placebo or lactose.

Anxiety, stress, depression, quality of life and quality of sleep

Patients with the inclusion criteria will be assigned to groups A or B based on a randomized list generated by using the technique of quadruple blocks procured from a software application known as Random Number Calculator. For the production of placebo, coordination will be made with Salamat Parmon Amin manufacturing company. It is requested that the drug manufacturer label the drug or placebo with a letter A or B, determined by a coin toss, and the opposite letter shall be assigned to the alternative option.

This interventional study will be conducted in a triple blind manner. Blinding includes patient, therapist and analyst. In order to make a placebo, coordination will be done with Salamat Parmon Amin production company and it is requested that the drug manufacturer put one of the letters A or B on the drug or placebo and the other letter on the other by using a lottery by throwing a coin. The confidentiality of both the drug and placebo types should be maintained until the conclusion of the data analysis, as a fundamental element of the research protocol, and after the analysis, the researcher will ask the person in charge of the drug manufacturing for the type of labels. This means that the therapist will not know the type of medicine or whether the medicine packages are placebo. Neither the patient nor the analyst will know about this. The placebo capsules will bear complete resemblance to the capsules of the intervention group in terms of their coating, color, and smell.