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IRCT20211110053030N11 IRCT 2025-11-15 Ilam University of Medical Sciences The effectiveness of a drink containing basil extract in reducing the severity of delayed onset muscle soreness: A randomized controlled trial The effectiveness of a drink containing basil extract in reducing the severity of delayed onset muscle soreness: A randomized controlled trial 2025-11-22 anticipated 80 Complete https://irct.ir/trial/87459 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be randomly assigned to the intervention and control groups using a block randomization method with a block size of 4. The randomization list will be prepared using Random Allocation Software (version 1.0) by an independent individual outside the implementation process. Random codes will be placed in opaque, sealed, numbered envelopes and returned in the order in which the participant entered. The study administrator, participant, and statistical analyst will not have access to the group allocation, Blinding description: This study is conducted in a triple-blind manner. Participants, the conducting researcher (responsible for implementing the intervention and collecting data), and the data analyst are unaware of their group allocation (intervention or control). The intervention drink and the control drink (placebo) are completely identical in terms of color, taste, odor, volume, packaging type, and presentation, and there are no recognizable features to distinguish between the two drinks. Allocation codes are generated by an independent person who is not involved in the implementation and analysis of the study and are kept in opaque, sealed, and numbered envelopes. Opening the codes will only be permitted after the data analysis is complete. 3 Muscle pain. Intervention 1: Intervention group: Participants in this group will receive one serving of a basil extract-based fortified drink (with a final volume of 250 ml) daily, the formulation of which will include: standardized basil extract (equivalent to 500 mg of flavonoids), 20-25 g of whey protein isolate, 3 g of creatine monohydrate, 5 g of microencapsulated L-glutamine, standardized ginger extract (at least 3 mg of gingerol), 200 mg of vitamin C, natural sweetener, and 10-15 ml of lemon juice to adjust pH. This combination will be consumed for four weeks, 30 minutes after training or on non-training days between 10 am and 12 am. Intervention 2: Control group: Participants in this group will receive a placebo that will be identical in appearance, color, volume (250 ml), and taste to the intervention drink, but will lack any active ingredients (including basil extract, protein, creatine, L-glutamine, ginger extract, and vitamin C). The drink will contain only water, a very small amount of natural flavoring, and an inert sweetener. The placebo will also be consumed for four weeks at the same time as the intervention group (30 minutes after training or on non-training days between 10 a.m. and 12 p.m.). No - There is not a plan to make this available Justification or reason for not sharing IPD is At the end of the study, a decision will be made by the research team.
public Alireza Vasiee
Danesh square, Hoveizeh st, 17th avenue
Ilam Iran (Islamic Republic of) 6931373847 +98 84 3222 7091 rezawest10@gmail.com Ilam University of Medical Sciences scientific Alireza Vasiee
Danesh square, Hoveizeh st, 17th avenue
Ilam Iran (Islamic Republic of) 6931373847 +98 84 3222 7091 rezawest10@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Regular physical activity, at least 3 exercise sessions per week, started within the last 6 months Normal body mass index Normal liver, kidney, thyroid function No regular use of NSAIDs or corticosteroids in the 7 days prior to the start of the study Not participating in any other clinical study in the past 3 months Not taking hormonal supplements Following the training cycle according to the protocol Absence of stomach and intestinal ulcers within the last 3 months 18 years no limit Male Sports injury during intervention Diagnosed with diabetes Diagnosed with autoimmune diseases Known history of allergy to basil, whey protein, creatine, glutamine, ginger, or vitamin C Administration of NSAIDs or corticosteroids during the intervention Changes in liver, kidney, and thyroid function in interventional medicine M79.1 Myalgia Rehabilitation Placebo Intervention group: Participants in this group will receive one serving of a basil extract-based fortified drink (with a final volume of 250 ml) daily, the formulation of which will include: standardized basil extract (equivalent to 500 mg of flavonoids), 20-25 g of whey protein isolate, 3 g of creatine monohydrate, 5 g of microencapsulated L-glutamine, standardized ginger extract (at least 3 mg of gingerol), 200 mg of vitamin C, natural sweetener, and 10-15 ml of lemon juice to adjust pH. This combination will be consumed for four weeks, 30 minutes after training or on non-training days between 10 am and 12 am. Control group: Participants in this group will receive a placebo that will be identical in appearance, color, volume (250 ml), and taste to the intervention drink, but will lack any active ingredients (including basil extract, protein, creatine, L-glutamine, ginger extract, and vitamin C). The drink will contain only water, a very small amount of natural flavoring, and an inert sweetener. The placebo will also be consumed for four weeks at the same time as the intervention group (30 minutes after training or on non-training days between 10 a.m. and 12 p.m.). Pain. Timepoint: Before the intervention and 4 weeks after the start of the intervention. Method of measurement: Visual analogue scale (VAS) pain assessment questionnaire. Ilam University of Medical Sciences Approved 2025-10-21 Ethics Committee of Ilam University of Medical Sciences Bangangab, Ilam University of Medical Sciences, Research and Technology Building Ilam Ilam Iran (Islamic Republic of)