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IRCT20191105045340N5 IRCT 2024-06-22 Iran University of Medical Sciences The effect of curcumin and bromelain in patients with diabetic neuropathy The effect of curcumin and bromelain on anxiety, stress, depression, quality of life and sleep quality in diabetic neuropathy patients. 2024-06-21 anticipated 100 Complete https://irct.ir/trial/77444 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 3 Diabetic neuropathy. Intervention 1: Intervention group: The intervention group consumes 2 capsules of the combined supplement of curcumin and bromelain each day, each capsule containing 150 mg of bromelain equivalent to 375 GDU and 300 mg of curcumin for 8 weeks. Intervention 2: Control group: The control group consumes 2 placebo capsules daily for 8 weeks. The placebo capsule contains lactose. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr.Seyedeh Tayebeh Rahideh
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 1021 tayebeh_rahideh@yahoo.com Iran University of Medical Sciences scientific Dr.Seyedeh Tayebeh Rahideh
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 1021 tayebeh_rahideh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Having type 2 diabetes based on the diagnosis of a specialist doctor Diabetic neuropathy in this study will be based on the diagnosis of a specialist doctor and clinical or paraclinical diagnostic criteria. Willingness to cooperate Age 40 to 65 years BMI of people should be in the range of 18.5 to 30 Absence of leg ulcers, visual disturbances and dizziness 40 years 65 years Both Allergy to pineapple Having neurological diseases that cause neuropathy. Taking drugs that interfere with treatment, such as neuroleptics such as SSRIs, antidepressants and anti-stress drugs, and non-steroidal anti-inflammatory drugs Taking anticoagulants E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Treatment - Other Treatment - Other Intervention group: The intervention group consumes 2 capsules of the combined supplement of curcumin and bromelain each day, each capsule containing 150 mg of bromelain equivalent to 375 GDU and 300 mg of curcumin for 8 weeks. Control group: The control group consumes 2 placebo capsules daily for 8 weeks. The placebo capsule contains lactose. Depression. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: Questionnaire DASS-21. Anxiety. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: Questionnaire DASS-21. Stress. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: Questionnaire DASS-21. Quality of life. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: SF-36 questionnaire. Sleep quality. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: Petersburg Questionnaire (PSQI). Iran University of Medical Sciences Approved 2024-05-11 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)