]>
IRCT20240603061995N4 IRCT 2026-08-14 Islamic Azad University Investigating the effect of creatine and paracetamol in resistance training Combined effects of creatine and paracetamol on muscular performance, fatigue, and recovery in resistance-trained athletes 2026-02-19 anticipated 30 Recruiting https://irct.ir/trial/89206 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants were allocated to the study groups (15 in the experimental group and 15 in the control group) using the balanced block randomization method with variable block sizes of 2 and 4. The randomization sequence was generated using Random Allocation Software (version 2.0.0). To ensure allocation concealment, the generated sequences were placed in sequentially numbered, opaque, sealed envelopes (SNOSE) by a third party who was not involved in the study. Envelopes were opened sequentially only after the completion of baseline assessments at the time of each participant's definitive entry into the study, ensuring that the investigator responsible for enrollment and assessment remained blinded to the group assignment until the last moment, Blinding description: This is a double-blind trial. Participants, principal investigator, care providers, outcome assessors, and data analysts are blinded to group allocation. Placebos match active supplements in appearance, color, taste, smell, and packaging, prepared, coded, and distributed by an independent third party. Emergency unblinding is available via study physician and ethics committee if needed. 3 Athletic performance and muscle fatigue in healthy athletes. Intervention 1: Intervention group: Daily oral consumption of creatine monohydrate (Karen Pharma) for 8 weeks; including a 5-day loading phase (20 g/day in four 5-g doses as water-soluble powder) followed by a maintenance phase (5 g/day in a single dose). Simultaneously, daily oral consumption of 500 mg paracetamol capsules (Amin Pharma) 1 hour before exercise for 8 weeks. The concurrent resistance training protocol consists of 8 weeks, 3 sessions per week, 60 minutes per session (intensity of 70 to 80 percent of 1-repetition maximum). Intervention 2: Control group: Daily oral consumption of placebos consisting of starch capsules and powders with identical appearance, color, and concentration to the main supplement and medication (Amin Pharma) with the exact same dosage, frequency, and timing as the intervention group for 8 weeks. The concurrent resistance training protocol is performed exactly identical to the intervention group (8 weeks, 3 sessions per week, 60 minutes per session, at an intensity of 70 to 80 percent of 1-repetition maximum). No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical considerations and the need to protect participant confidentiality, as well as the absence of explicit informed consent for sharing individual data, there is no plan to share IPD. Additionally, resources for complete data anonymization are not available.
public Morteza Jourkesh
Islamic Azad University Ilkhchi Branch Complex, Imam St., Ilkhchi, East Azerbaijan, Ilkhchi
tehran Iran (Islamic Republic of) 5358114418 04133421214-7 mjourkesh@ut.ac.ir Islamic Azad University scientific Morteza Jourkesh
No.34, Shahid Salimi alley, Loghmane Hakim avenue, Jalaliyeh street, Tabriz
Tabriz Iran (Islamic Republic of) 5176678381 +98 41 3443 9830 mjourkesh@ut.ac.ir Islamic Azad University Iran (Islamic Republic of) Gender: Male Age range: 18 to 30 years ​At least 3 years of regular specialized training experience in endurance or strength sports ​Complete physical health and absence of chronic or acute diseases ​Commitment to strictly adhere to the training program, diet, and intervention protocol 18 years 30 years Male Presence of chronic or serious diseases (cardiovascular, hepatic, renal, or other conditions affecting athletic performance) ​History of acute musculoskeletal injury in the past 6 months ​Regular use of interfering medications or supplements (such as steroids, potent antioxidants, creatine, or paracetamol) in the past 3 months Other Other Intervention group: Daily oral consumption of creatine monohydrate (Karen Pharma) for 8 weeks; including a 5-day loading phase (20 g/day in four 5-g doses as water-soluble powder) followed by a maintenance phase (5 g/day in a single dose). Simultaneously, daily oral consumption of 500 mg paracetamol capsules (Amin Pharma) 1 hour before exercise for 8 weeks. The concurrent resistance training protocol consists of 8 weeks, 3 sessions per week, 60 minutes per session (intensity of 70 to 80 percent of 1-repetition maximum). Control group: Daily oral consumption of placebos consisting of starch capsules and powders with identical appearance, color, and concentration to the main supplement and medication (Amin Pharma) with the exact same dosage, frequency, and timing as the intervention group for 8 weeks. The concurrent resistance training protocol is performed exactly identical to the intervention group (8 weeks, 3 sessions per week, 60 minutes per session, at an intensity of 70 to 80 percent of 1-repetition maximum). Maximal muscular strength. Timepoint: Measurement of muscle performance, fatigue, and recovery at the beginning of the study (before the start of intervention) and 8 weeks after the start of intervention. Method of measurement: One-repetition maximum test in squat, bench press, and deadlift using standard protocol. Muscular fatigue index. Timepoint: Baseline (before the start of intervention) and after the end of 8 weeks of intervention. Method of measurement: Repetitions in final sets or fatigue ratio during supervised sessions. Delayed onset muscle soreness. Timepoint: Measurement of muscle performance, fatigue, and recovery at the baseline (before the start of intervention) and after the end of 8 weeks of intervention. Method of measurement: Visual Analogue Scale or numerical rating scale (0–10). Serum creatine kinase level. Timepoint: Measurement of muscle performance, fatigue, and recovery at the beginning of the study (before the start of intervention) and after the end of 8 weeks of intervention. Method of measurement: Venous blood sampling and enzymatic or immunoassay analysis in accredited lab. Islamic Azad University Islamic Azad University Islamic Azad University Approved 2025-05-27 Research Ethics Committees of Islamic Azad University-Tabriz Islamic Azad University, Tabriz Medical Sciences Branch Sahraei Ahar Intersection, Basmenj Road, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)