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IRCT20251028067794N1 IRCT 2026-04-22 Esfahan University of Medical Sciences Investigating of the Effect of Ginger Supplementation in Patients with Parkinson’s Disease Investigating the Effect of Ginger Supplementation on Antioxidant and oxidant Markers, Clinical Outcome and Quality of Life in Patients with Parkinson's Disease: Double-blind, parallel, randomized controlled trial 2026-04-21 anticipated 48 Complete https://irct.ir/trial/87235 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants in the intervention group will receive 2 tablets of 500 mg ginger powder daily for 12 weeks. Participants in the control group will receive 2 tablets of 500 mg cornstarch as placebo daily for the same 12-week period. Since the practical recommendation in the present study is to use ginger powder as a culinary spice, participants will be instructed to take one of the two daily tablets with each of the main meals, namely lunch and dinner.The physical characteristics of the ginger and placebo tablets, including size, shape, and color, will be identical. Additionally, a very small amount of ginger powder will be added to each bottle of placebo tablets to ensure that the odor matches that of the ginger tablet bottles. It should be noted that both ginger and placebo tablets used in this study will be provided by Dineh Iran Industrial Complex. According to the manufacturer, each 500 mg ginger tablet contains the equivalent of 5 mg of ginger essential oil, including active compounds such as terpenes and phenolic compounds. Each 500 mg ginger tablet is standardized to contain 25 mg of gingerol, Randomization description: Randomization will be performed using stratified block randomization with balanced blocks of size 4 and an allocation ratio of 1:1. The randomization process will be stratified based on sex and disease severity according to the Hoehn and Yahr scale. The random allocation sequence will be generated by the study statistician using the Sealed Envelope online randomization system. The sequence will then be stored in a password‑protected file inaccessible to the research team. Only the clinical officer of the Parkinson Charity Association, who is not involved in assessments or data collection, will have access to the sequence. Based on this sequence, ginger supplement bottles and placebo bottles will be prepared to be visually identical and labeled with sequential numeric codes. The bottles will be placed inside opaque, sealed, and tamper‑proof envelopes. Each participant will receive the envelope corresponding to their assigned code only after confirming eligibility and completing baseline assessments. Researchers, healthcare providers, outcome assessors, and participants will remain fully blinded to group allocation throughout the study. The allocation code will be broken only after data collection is completed and with approval from the ethics committee. This method ensures full allocation concealment and minimizes the risk of selection bias, Blinding description: This study will employ a double‑blind design. Participants, clinical care providers, investigators, outcome assessors, and data analysts will all be blinded to group allocation. The ginger supplement and placebo will be identical in appearance, smell, packaging, and labeling, and will be distributed in opaque, sealed, and sequentially numbered envelopes. The clinical officer responsible for dispensing the envelopes will not be involved in any aspect of participant assessment, data collection, or analysis. Outcome assessors and laboratory personnel will receive samples and questionnaires labeled only with participant codes, with no indication of intervention status. Data analysts will work with anonymized datasets that contain no allocation information. Unblinding will occur only after completion of data collection and with approval from the ethics committee. This procedure ensures full blinding of all key study personnel and minimizes performance and detection bias. N/A Parkinson’s disease. Intervention 1: Intervention group: Participants in the intervention group will receive two 500 milligram tablets containing standardized ginger powder daily for twelve weeks. Each tablet contains 500 milligrams of standardized ginger powder, equivalent to 25 milligrams of active gingerol. The tablets should be consumed with one of the main meals, either lunch or dinner. The ginger tablets are manufactured by Dineh Iran Industrial Complex and have been matched in size, shape, color, and smell with the placebo tablets. Intervention 2: Control group: Participants in the control group will receive two 500 milligram tablets containing corn flour as a placebo daily for twelve weeks. The placebo tablets have been matched in size, shape, color, and smell with the ginger tablets to ensure that participants and researchers remain blinded to group allocation. Yes - There is a plan to make this available What will be shared: De-identified Individual Participant Data (IPD), study protocol, statistical analysis plan (SAP), informed consent form, statistical analysis codes, and data dictionary. These materials include de-identified participant-level data, the final protocol, SAP, shareable informed consent form, analysis scripts (without raw data), and the coding structure used in the study. All IPD will be provided only in fully anonymized form. When: Data and documents will be available starting 6 months after publication of the primary results and will remain accessible for at least 5 years thereafter. To whom: Qualified researchers affiliated with academic, clinical, or recognized research institutions may request access. Conditions: Data may be used only for valid scientific research and secondary analyses. Applicants must: Submit a clear research proposal Sign a data use and confidentiality agreement Agree not to re-identify participants or share the data with others. Where to obtain: Name: Maziar Ghasemi Faculty: School of Nutrition and Food Sciences University: Isfahan University of Medical Sciences, Hezarjarib St., Isfahan, Iran Email: maziar_gh@nutr.mui.ac.ir Alternative email: Maziar.dietitian@gmail.com Phone (optional): +98 921 844 8305 How to obtain: Within 2–4 weeks after receiving a request: The research proposal is reviewed by the study team Ethical compatibility is assessed A Data Use Agreement must be signed De-identified data are prepared and shared via a secure platform Comments: Additional supporting documents may be provided upon justified request.
public Maziar Ghasemi
کشاورزی، ب کشاورزی، خیابان کشاورز، کوی یخچال، خوابگاه پسرانه کوثر
isfahan Iran (Islamic Republic of) 8174884779 +98 921 844 8305 maziar_gh@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Reza Amani
Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran
isfahan Iran (Islamic Republic of) 8174673461 - r_amani@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 50 and 80 years Body Mass Index (BMI) greater than 18.5 Patients willing to participate in the study and able to provide written informed consent Diagnosis of Parkinson’s disease confirmed by a neurologist based on established diagnostic criteria Stable medication regimen for at least one month prior to the beginning of the study 50 years 80 years Both Following specific dietary regimens (such as ketogenic, fasting, etc.) within one month before the start of the study Consumption of ginger-enriched products within one month before the start of the study Presence of hypo- or hyperthyroidism Presence of severe psychosis or other concurrent neurological disorders Cognitive impairment based on the MOCA criteria Mood disorders such as severe depression, bipolar disorder, or severe anxiety (as determined by a neurologist) Known allergy or hypersensitivity to ginger Hoehn and Yahr score equal to 5 Use of cigarettes, nicotine, or alcohol Use of anticoagulant medications Use of anti-inflammatory or immunosuppressive drugs Receiving insulin therapy Use of antioxidant supplements G20 Parkinson's disease Treatment - Drugs Placebo Intervention group: Participants in the intervention group will receive two 500 milligram tablets containing standardized ginger powder daily for twelve weeks. Each tablet contains 500 milligrams of standardized ginger powder, equivalent to 25 milligrams of active gingerol. The tablets should be consumed with one of the main meals, either lunch or dinner. The ginger tablets are manufactured by Dineh Iran Industrial Complex and have been matched in size, shape, color, and smell with the placebo tablets. Control group: Participants in the control group will receive two 500 milligram tablets containing corn flour as a placebo daily for twelve weeks. The placebo tablets have been matched in size, shape, color, and smell with the ginger tablets to ensure that participants and researchers remain blinded to group allocation. Change in Parkinson’s disease severity based on the total score of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale. Timepoint: Assessment of Parkinson’s disease severity at baseline before the start of the intervention and at the end of week twelve after completion of the intervention. Method of measurement: Movement Disorder Society Unified Parkinson’s Disease Rating Scale. Change in serum level of Superoxide dismutase. Timepoint: Measurement of serum Superoxide dismutase at baseline before the start of the intervention and at the end of week twelve of the intervention. Method of measurement: Measurement of serum Superoxide dismutase using standard biochemical methods. Change in serum level of Glutathione peroxidase. Timepoint: Measurement of serum Glutathione peroxidase at baseline before the start of the intervention and at the end of week twelve of the intervention. Method of measurement: Measurement of serum Glutathione peroxidase using standard biochemical methods. Change in serum total antioxidant capacity. Timepoint: Measurement of serum total antioxidant capacity at baseline before the start of the intervention and at the end of week twelve of the intervention. Method of measurement: Measurement of serum total antioxidant capacity using standard biochemical methods. Change in serum total oxidant status. Timepoint: Measurement of serum total oxidant status at baseline before the start of the intervention and at the end of week twelve of the intervention. Method of measurement: Measurement of serum total oxidant status using standard biochemical methods. Change in quality of life in patients with Parkinson’s disease. Timepoint: Assessment of quality of life in patients with Parkinson’s disease at baseline before the start of the intervention and at the end of week twelve of the intervention. Method of measurement: Parkinson’s disease quality of life questionnaire. Esfahan University of Medical Sciences Approved 2026-04-06 Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien Hezarjarib St., school of Pharmacy and Pharmaceutical Sciences, Isfahan, Iran isfahan Isfehan Iran (Islamic Republic of)