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IRCT20201129049534N13 IRCT 2026-05-30 Esfahan University of Medical Sciences The effect of quercetin and bromelain co-supplementation (capsule of Brozyme Plus) on Parkinson's disease Evaluation the effect of quercetin and bromelain co-supplementation (capsule of Brozyme Plus) on some inflammatory indices, oxidative stress, and clinical signs in patients with Parkinson's disease: A triple-blind randomized controlled clinical trial 2026-06-22 anticipated 90 Recruiting https://irct.ir/trial/89515 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to the intervention and placebo groups using a stratified block randomization method with a block size of 4 and individual as the unit of randomization. For this purpose, people will be classified into 4 states based on the variables of gender and stage of the disease and people with the same states will be randomly assigned to intervention and placebo groups in a 1:1 ratio.The random sequence will be generated using a software-based random number generator provided by www.sealedenvelope.com/simple, and the allocation process will be performed by an independent researcher. In addition, allocation concealment will be ensured using opaque, sealed, and sequentially numbered envelopes containing group codes, Blinding description: This study will be designed as a triple-blind randomized clinical trial. Capsules of Brozyme Plus (containing Quercetin and bromelain) and placebo will be prepared to be identical in color, shape, odor, and route of administration, and will be provided in identical packaging so that participants cannot distinguish between them, ensuring participant-level blinding. For blinding, the products will be labeled with coded identifiers A and B, and the true identity of each code will be known only to an independent researcher not involved in the trial. Participants, investigators responsible for interviews and sampling, laboratory assessors, and statisticians will remain blinded to group allocation throughout the study. 3 Parkinson. Intervention 1: Intervention: Two capsules of Brozyme Plus per day from the Office of Tachra pharmed, each containing 400 mg quercetin and 82.5 mg bromelain, (total daily dose: 800 mg quercetin and 165 mg bromelain), for 12 weeks. Intervention 2: Control group: Two placebo capsules per day from the Office of Tachra pharmed, each containing 482.5 mg of magnesium stearate (total daily dose: 965 mg), for 12 weeks. 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 In the informed consent form approved by the ethics committee, participants were assured that their individual data would be used solely for the purposes of this study and would not be shared with any other person or organization. Therefore, public sharing of IPD is not possible. However, anonymized individual participant data will be made available by the corresponding author to qualified researchers upon reasonable request and approval by the ethics committee.
public Mohammad Bagherniya
Hezar-jerib Ave
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3154 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Bagherniya
Hezar-jerib Ave
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3154 bagherniya@nutr.mui.ac.i Esfahan University of Medical Sciences Iran (Islamic Republic of) Provision of informed consent and willingness to participate in the study Men and women (postmenopausal women) aged 45 years or older Parkinson’s disease diagnosed according to the UK Parkinson’s Disease Society Brain Bank diagnostic criteria (UKPDSBB). Hoehn and Yahr stage <5 Body Mass Index (BMI) ≤40 kg/m² 45 years no limit Both Adherence to a specific diet or consumption of quercetin or bromelain supplements within the past three months. Take of immunosuppressive medications, or use of medications that may interact with quercetin and bromelain supplements, such as warfarin. Diagnosis or history of other neurodegenerative disorders, including Huntington’s disease, multiple sclerosis (MS); Wilson’s disease, central nervous system infections, such as meningitis. Hoehn and Yahr stage of 5 out of 5. History of allergy to quercetin or hypersensitivity to grapes . History of allergy to bromelain or hypersensitivity to pineapple, celery, fennel, or carrot. G20 Parkinson's disease Treatment - Drugs Placebo Intervention: Two capsules of Brozyme Plus per day from the Office of Tachra pharmed, each containing 400 mg quercetin and 82.5 mg bromelain, (total daily dose: 800 mg quercetin and 165 mg bromelain), for 12 weeks Control group: Two placebo capsules per day from the Office of Tachra pharmed, each containing 482.5 mg of magnesium stearate (total daily dose: 965 mg), for 12 weeks Tumor necrosis alpha factor(TNFα). Timepoint: Before and after intervention. Method of measurement: ELISA test. Malondialdehyde (MDA). Timepoint: Before and after intervention. Method of measurement: Commercial Malondialdehyde Kit by Colorimetric Method. C reactive Protein (CRP). Timepoint: Before and after intervention. Method of measurement: ELISA test. Stage of disease. Timepoint: Before and after intervention. Method of measurement: Hoehn and Yahr scale. Interleukin 6. Timepoint: Before and after intervention. Method of measurement: ELISA Test. Quality of life. Timepoint: Before and after intervention. Method of measurement: Parkinson's Disease Questionnaire - 39 (PDQ-39). Mental Health (Depression, Anxiety , Stress). Timepoint: Before and after intervention. Method of measurement: Depression Anxiety Stress Scale -21 (DASS). Sleep Quality. Timepoint: Before and after intervention. Method of measurement: Parkinson's Disease Sleep Scale (PDSS). Appetite. Timepoint: Before and after intervention. Method of measurement: Simplified Nutritional Appetite Questionnaire (SNAQ). Cognitive Status. Timepoint: Before and after intervention. Method of measurement: Abbreviated Mental Test (AMT). Anthropometric Index. Timepoint: Before and after intervention. Method of measurement: Scale and Stadiometer. Blood pressure. Timepoint: Before and after intervention. Method of measurement: Digital Blood Pressure Monitor. SOD. Timepoint: Before and after intervention. Method of measurement: Commercial superoxide dismutase diagnostic kit using the colorimetric method. Total Antioxidant Capacity(TAC). Timepoint: Before and after intervention. Method of measurement: Commercial Total Antioxidant Capacity kit using the colorimetric method. Interleukin 1 beta. Timepoint: Before and after intervention. Method of measurement: ELISA Test. Esfahan University of Medical Sciences Approved 2026-04-17 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue Esfahan Isfehan Iran (Islamic Republic of)