NICEVIVA
MONOGRAPH SPEC LATEST 2026

Tribulus Terrestris

BOTANICALS · Evidence Monograph

Tribulus Terrestris is an evidence-graded botanicals monograph evaluated across 20 peer-reviewed PubMed studies (4 meta-analyses, 6 systematic reviews, and 3 randomized controlled trials, encompassing n = 854 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 20 Studies
Meta-Analyses · Reviews 4 Meta · 6 Systematic Reviews
Randomized Trials (RCT) 3 RCTs (1 Double-Blind)
Cumulative Participants n = 854
Reported Trial Dosages 770 mg/day · 770 mg · 750 mg/day
Trial Duration Range 6 weeks · 21 days · 42 days
Reading Time ~10 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 20 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (770 mg/day · 770 mg · 750 mg/day) over a structured 6 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (20 PubMed studies)
Quantitative biomarker & outcome analysis (10 studies with effect-size/sample data)
Randomized controlled trial verification (3 RCTs · 1 double-blind)
Systematic review & meta-analysis synthesis (4 meta-analyses · 6 reviews)
01

What Is Tribulus Terrestris & Why Does Form Matter?

Tribulus Terrestris is classified under BOTANICALS and has been investigated across 20 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (770 mg/day, 770 mg, 750 mg/day).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Tribulus Terrestris frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (3 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Tribulus Terrestris acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Tribulus Terrestris an overall evidence rating of GRADE High (4.0 / 4.0) based on 20 PubMed studies: 4 meta-analyses, 6 systematic reviews, and 3 randomized controlled trials (1 double-blind, n = 854 total participants).

Representative peer-reviewed findings include: • PMID:40360723 (2026) — "Tribulus terrestris for management of patients with erectile dysfunction: a systematic review and meta-analysis of randomized trials." (Suharyani S(1), Amanda B(1), Angellee J(1)(2), William W(3)(4), Hariy) • PMID:37686709 (2023) — "Dietary Supplements for Erectile Dysfunction: Analysis of Marketed Products, Systematic Review, Meta-Analysis and Rational Use." (A metanalysis identified some nutraceuticals, such as Panax ginseng, Tribulus terrestris and L-arginine, that are able to improve male sexual function.) • PMID:29633089 (2018) — "Herbal Dietary Supplements for Erectile Dysfunction: A Systematic Review and Meta-Analysis." (However, further, larger, and high-quality studies are required before firm conclusions can be drawn.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 770 mg/day · 770 mg · 750 mg/day over 6 weeks · 21 days · 42 days · 4 weeks. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Tribulus Terrestris, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (770 mg/day · 770 mg · 750 mg/day) and re-evaluate efficacy after 6 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (20 Studies) · 10 Quantitative Analyses

01
META-ANALYSIS International journal of impotence research (2026) PMID: 40360723 ↗
Tribulus terrestris for management of patients with erectile dysfunction: a systematic review and meta-analysis of randomized trials.
Clinical Trial Synthesis 2026 Meta-Analysis published in International journal of impotence research; statistical significance reported at p = 0.00001 (MD 4.21). Key conclusion: Suharyani S(1), Amanda B(1), Angellee J(1)(2), William W(3)(4), Hariy
View Original PubMed Abstract ↓

1. Int J Impot Res. 2026 Jan;38(1):11-18. doi: 10.1038/s41443-025-01086-7. Epub 2025 May 13. Tribulus terrestris for management of patients with erectile dysfunction: a systematic review and meta-analysis of randomized trials. Suharyani S(1), Amanda B(1), Angellee J(1)(2), William W(3)(4), Hariy

02
META-ANALYSIS Nutrients (2023) PMID: 37686709 ↗
Dietary Supplements for Erectile Dysfunction: Analysis of Marketed Products, Systematic Review, Meta-Analysis and Rational Use.
Clinical Trial Synthesis 2023 Meta-Analysis published in Nutrients. Key conclusion: A metanalysis identified some nutraceuticals, such as Panax ginseng, Tribulus terrestris and L-arginine, that are able to improve male sexual function.
View Original PubMed Abstract ↓

The use of nutraceutical products to enhance male sexual performance has a long history, especially with regard to the treatment of erectile dysfunction (ED). Alternative treatments for ED are becoming increasingly popular, with growing interest from consumers, as well as increased revenue for manufacturers. Dietary supplements (DSs), which are a mixture of active ingredients, are mainly sold online. In randomized controlled trials, the molecules contained in DSs have demonstrated varying degrees of effectiveness, or even have no evidence to support their use. However, none of the studies carried out provided sufficient evidence to consider these products a first-line therapy. Therefore, the combination of the various active ingredients, especially in relation to the daily dose, leaves doubts about the real effectiveness. In order to evaluate the potential efficacy of DS formulations, we analyzed the products marketed in Italy using a scoring approach. A systematic review of the literature was performed to evaluate the effect of DS and to detect the active ingredients able to improve erectile function-called effective ingredients (EIs)-and their minimal effective daily dose (mED). A metanalysis identified some nutraceuticals, such as Panax ginseng, Tribulus terrestris and L-arginine, that are able to improve male sexual function. Based on the scoring system, 2 (8%) supplements matched with the cluster of higher expected efficacy, 3 (12%) with the lower efficacy cluster and 20 (80%) matched with the criterion of no expected efficacy. DSs marketed in Italy are usually blends of many substances that are frequently employed at a negligible dose or without any evidence.

03
META-ANALYSIS Drugs (2018) PMID: 29633089 ↗
Herbal Dietary Supplements for Erectile Dysfunction: A Systematic Review and Meta-Analysis.
Clinical Trial Synthesis 2018 Meta-Analysis published in Drugs involving n = 399 participants; statistical significance reported at p = 0.01. Key conclusion: However, further, larger, and high-quality studies are required before firm conclusions can be drawn.
View Original PubMed Abstract ↓

PURPOSE: Erectile dysfunction (ED) is a common condition that significantly affects quality of life and interpersonal relationships. OBJECTIVE: Our objective was to perform a systematic review and meta-analysis to evaluate the efficacy of herbal dietary supplements in the treatment of ED. MATERIALS AND METHODS: We searched five databases to identify randomized controlled trials (RCTs) that evaluated the clinical efficacy of herbal medicines in ED. Quality was assessed and risk of bias was estimated using the Jadad score and the Cochrane risk-of-bias tool. RESULTS: In total, 24 RCTs, including 2080 patients with ED, were identified. Among these, 12 evaluated monopreparations (five ginseng [n = 399], three saffron [n = 397], two Tribulus terrestris [n = 202], and one each Pinus pinaster [n = 21] and Lepidium meyenii [n = 50]), seven evaluated formulations (n = 544), and five investigated dietary supplements in combination with pure compounds (n = 410). Ginseng significantly improved erectile function (International Index of Erectile Function [IIEF]-5 score: 140 ginseng, 96 placebo; standardized mean difference [SMD] 0.43; 95% confidence interval [CI] 0.15-0.70; P < 0.01; I2 = 0), P. pinaster and L. meyenii showed very preliminary positive results, and saffron and T. terrestris treatment produced mixed results. Several herbal formulations were associated with a decrease of IIEF-5 or IIEF-15, although the results were preliminary. The quality of the included studies varied, with only seven having a prevalent low risk of bias. The median methodological quality Jadad score was three out of a maximum of five. Adverse events were recorded in 19 of 24 trials, with no significant differences between placebo and verum in placebo-controlled studies. CONCLUSIONS: Encouraging evidence suggests that ginseng may be an effective herbal treatment for ED. However, further, larger, and high-quality studies are required before firm conclusions can be drawn. Promising (although very preliminary) results have also been generated for some herbal formulations. Overall, more research in the field, adhering to the CONSORT statement extension for reporting trials, is justified before the u

04
CLINICAL STUDY African journal of reproductive health (2026) PMID: 41537313 ↗
Effectiveness of electroacupuncture in improving sperm motility and morphology in men with varicocele.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in African journal of reproductive health involving n = 14 participants; statistical significance reported at p = 0.029. Key conclusion: These findings suggest that EA significantly enhances sperm quality in varicocele patients and may serve as an effective complementary treatment for male infertility.
View Original PubMed Abstract ↓

Infertility affects 15% of couples worldwide, with male factors contributing to over half of the cases. Varicocele, present in 35% of men with primary infertility, impairs sperm quality. This study evaluates the effect of electroacupuncture (EA) on improving sperm motility and morphology in varicocele patients. A single-blind, randomized controlled trial was conducted with 14 participants divided into an EA group (n=7) and a control group (n=7). The intervention group received EA in combination with a herbal regimen and Tribulus Terrestris, while the control group received only the herbal regimen and Tribulus Terrestris without EA. Men aged 20-35 with ultrasound-confirmed varicocele and abnormal spermiograms were included. Statistical analysis used the paired t-test, Wilcoxon, and Mann-Whitney tests. The EA group showed significant improvements in sperm morphology (P=0.029) and motility (P=0.026) compared to the control group. These findings suggest that EA significantly enhances sperm quality in varicocele patients and may serve as an effective complementary treatment for male infertility. Publisher: L'infertilité touche 15 % des couples dans le monde, les facteurs masculins contribuant à plus de la moitié des cas. La varicocèle, présente chez 35 % des hommes souffrant d'infertilité primaire, altère la qualité du sperme. Cette étude évalue l'effet de l'électroacupuncture (EA) sur l'amélioration de la motilité et de la morphologie des spermatozoïdes chez les patients atteints de varicocèle. Un essai contrôlé randomisé en simple aveugle a été mené auprès de 14 participants répartis en deux groupes: un groupe EA (n=7) et un groupe témoin (n=7). Le groupe d'intervention a reçu une combinaison d'EA, d'un traitement à base de plantes et de Tribulus Terrestris, tandis que le groupe témoin a reçu uniquement le traitement à base de plantes et le Tribulus Terrestris sans EA. Des hommes âgés de 20 à 35 ans, présentant une varicocèle confirmée par échographie et des anomalies au spermogramme, ont été inclus. L'analyse statistique a utilisé les tests t apparié, de Wilcoxon et de Mann-Whitney. Le groupe EA a montré une amélioration significative de la morphologie (P=0.029)

05
RANDOMIZED TRIAL (RCT) Medicina (Kaunas, Lithuania) (2023) PMID: 37763782 ↗
Effects of Aphrodite (an Herbal Compound) on SSRI-Induced Sexual Dysfunctions and Depression in Females with Major Depressive Disorder: Findings from a Randomized Clinical Trial.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Medicina (Kaunas, Lithuania). Key conclusion: Conclusions: The pattern of results suggests that compared to placebo, Aphrodite appeared to improve symptoms of sexual dysfunction, depression, and anxiety among females with diagnosed MDD and SSRI-induced sexual dysfunction.
View Original PubMed Abstract ↓

Background and Objectives: Almost by default, people with major depression disorder (MDD) also report sexual health issues. This holds even more true when sexual dysfunctions are SSRI-induced. Herbal compounds may have the power to counterbalance such sexual dysfunctions, though research is still scarce. Therefore, we assessed females with diagnosed MDD treated with a standard SSRI (sertraline) and reporting SSRI-induced sexual dysfunctions, and we asked whether compared to placebo, Aphrodite (a blend of ginger, saffron, cinnamon, thistle, and Tribulus terrestris) may favorably impact on sexual dysfunctions, and on symptoms of depression, anxiety, and sleep disturbances. Materials and Methods: A total of 41 females (mean age: 35.05 years) with diagnosed MDD, treated with sertraline (a standard SSRI) at therapeutic dosages, and reporting SSRI-induced sexual dysfunction, were randomly assigned either to Aphrodite or to the placebo condition. At baseline and four and eight weeks later (study end), participants completed a series of self-rating questionnaires covering symptoms of sexual dysfunction, depression, anxiety, and sleep complaints. Results: Symptoms of sexual dysfunction, depression, and anxiety decreased over time, but more so in the Aphrodite condition, compared to the placebo condition (significant p-values and large effect sizes). Over time, sleep disturbances decreased irrespective of the study condition. Conclusions: The pattern of results suggests that compared to placebo, Aphrodite appeared to improve symptoms of sexual dysfunction, depression, and anxiety among females with diagnosed MDD and SSRI-induced sexual dysfunction. Further and similar studies should investigate the underlying psychophysiological mechanisms.

06
RANDOMIZED TRIAL (RCT) International journal of environmental research and public health (2022) PMID: 36498228 ↗
6-Week Supplementation with Tribulus terrestris L. to Trained Male CrossFit(®) Athletes on Muscle, Inflammation, and Antioxidant Biomarkers: A Randomized, Single-Blind, Placebo-Controlled Trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in International journal of environmental research and public health; statistical significance reported at p = 0.05. Key conclusion: No significant (p > 0.05) decreases in muscle damage or inflammation biomarkers were observed, although a slight downward trend was observed after 6 weeks for supplemented athletes.
View Original PubMed Abstract ↓

Tribulus terrestris L. (TT) ingredients have anti-inflammatory and antioxidant activities, but their effects on exercise-induced muscle damage (EIMD) in trained athletes are uncertain. The purpose of this single-blind placebo-controlled trial, in accordance with CONSORT guidelines, was to examine the effect of 6 weeks of TT supplementation on muscle metabolism, inflammation biomarkers, and oxidant status. Thirty trained male CrossFit® athletes were randomly assigned to be supplemented with 770 mg/day of TT (intervention group (IG)) or receive a placebo daily (control group (CG)) for 6 weeks. Muscle damage enzymes, inflammation biomarkers, and Total Antioxidant Status (TAS) were assessed at baseline (T1), 21 days after baseline (T2), and after 42 days (T3). Grace, a Workout of the Day, was measured in T1 and T3. Statistical significance (p < 0.05) was found between IG and CG in Lactate Dehydrogenase (LDH), C-reactive protein (CRP), and TAS levels at the end of the follow-up. Furthermore, TAS levels were significantly (p < 0.05) lower at T2 and T3 relative to baseline in the IG, also LDH and CRP increased significantly (p < 0.05) at T2 and T3 relative to baseline in the CG. No significant (p > 0.05) decreases in muscle damage or inflammation biomarkers were observed, although a slight downward trend was observed after 6 weeks for supplemented athletes. TT supplementation could attenuate the CrossFit® training program-induced oxidative stress, muscle damage, and inflammation which could be due to the natural antioxidant and anti-inflammatory properties of TT.

07
CLINICAL STUDY Journal of dietary supplements (2023) PMID: 36073362 ↗
Effect of Tribulus terrestris L. supplementation on Exercise-Induced Oxidative Stress and Delayed Onset Muscle Soreness Markers: A Pilot Study.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Journal of dietary supplements; statistical significance reported at p = 0.05. Key conclusion: supplementation effectively attenuates oxidative stress responses but cannot improve DOMS.
View Original PubMed Abstract ↓

Tribulus terrestris L. contains compounds with antioxidant and anti-inflammatory properties, but its effects on exercise-induced oxidative stress and inflammatory responses are unclear. The aim of this study was to examine whether Tribulus terrestris L. supplementation can attenuate oxidative stress and inflammatory responses to acute aerobic exercise and improve DOMS. In a randomized, double-blind, crossover design study, thirteen healthy men received either a daily supplement of Tribulus terrestris L. or a placebo for 4 weeks (2-week wash-out period between trials). Before and after the supplementation periods, participants performed an exercise test to exhaustion (75% VO2max). DOMS, thigh girth, and knee joint range of motion (KJRM) were assessed before and after the exercise (2, 24, and 48 h). Blood samples were analyzed for reduced (GSH) and oxidized (GSSG) glutathione, GSH/GSSG ratio, protein carbonyls, total antioxidant capacity, creatine kinase activity, white blood cell count, and TBARS. Acute exercise to exhaustion induced inflammatory responses and changed the blood redox status in both Tribulus and Placebo groups (p < 0.050). Tribulus terrestris L. improved GSH fall (p = 0.005), GSSG rise (p = 0.001) and maintained a higher level of GSH/GSSG ratio at the 2 h point (p = 0.034). TBARS were lowered, protein carbonyls, creatine kinase activity, and white blood cell count elevation diminished significantly (p < 0.050). Tribulus terrestris L. administration did not affect DOMS, thigh girth, or KJRM (p > 0.050). 4-weeks of Tribulus terrestris L. supplementation effectively attenuates oxidative stress responses but cannot improve DOMS.

08
RANDOMIZED TRIAL (RCT) Nutrients (2021) PMID: 34836225 ↗
The Effects of 6 Weeks of Tribulus terrestris L. Supplementation on Body Composition, Hormonal Response, Perceived Exertion, and CrossFit(®) Performance: A Randomized, Single-Blind, Placebo-Controlled Study.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in Nutrients; statistical significance reported at p = 0.05. Key conclusion: There were no significant group x time interactions for the outcomes of the study except for testosterone levels and bench press performance (p < 0.05).
View Original PubMed Abstract ↓

Tribulus terrestris L. (TT) supplementation have been shown to enhance sports performance in many but not all studies. Moreover, data regarding the potential impact of TT supplementation on CrossFit® endurance is limited. This study aimed to determine whether TT supplementation improve body composition, hormonal response, and performance among CrossFit® athletes. In a randomized, single-blind, placebo-controlled trial, a total of 30 healthy CrossFit®-trained males were randomly allocated to receive either 770 mg of TT supplementation or a placebo daily for 6 weeks. Body mass, fat mass, fat composition, testosterone and cortisol levels, and CrossFit® performance (5 common Workouts of the Day: back squat, bench press, dead lift, Grace, and CrossFit® Total) were assessed before and after intervention. There were no significant group x time interactions for the outcomes of the study except for testosterone levels and bench press performance (p < 0.05). TT supplementation did not impact enhance performance or body composition in CrossFit® male athletes. However, TT supplementation may act as a testosterone booster helping the recovery after physical loads and mitigating fatigue.

09
CLINICAL STUDY International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition (2021) PMID: 32375572 ↗
Tribulus Terrestris may decrease muscle damage markers following a high-intensity resistance exercise: A pilot study.
Clinical Trial Synthesis 2021 Clinical Study published in International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition; statistical significance reported at p = 0.001. Key conclusion: In conclusion, short-term supplementation with TT has no effect on IL-6 and hs-CRP, but may be effective on the reduction of muscle damage enzymes CPK and LDH following high-intensity circuit RE.
View Original PubMed Abstract ↓

The purpose of this study was to investigate the effect of two weeks of Tribulus Terrestris (TT) on the responses of Interleukin-6 (IL-6), high sensitivity C-reactive protein (hs-CRP), and enzymes creatine phosphokinase (CPK) and lactate dehydrogenase (LDH) following a single session of resistance exercise (RE). Eighteen healthy non-athlete males (age: 22.44 ± 2.54 years, BMI: 26.15 ± 1.62 kg/m2) participated in this study and were divided randomly into two 9-person groups of supplementation or placebo. The participants consumed two 250-mg capsules of TT or placebo (maltodextrin) per day and performed six REs with the intensity 80, 85, and 90% of 1RM in three circles at the day after the end of supplementation period. Blood samples were collected before the initiation of supplementation, and before and after the RE session. Total changes of IL-6 (p<0.001) and LDH (p=0.005) were significant in both groups. Bonferroni post hoc test showed that increased values of IL-6 and CPK in both groups were significant after exercise compared with pre-exercise and baseline (p<0.001). There were no significant differences in relation to within- and between-group changes in hs-CRP (p>0.05). Moreover, differences between the groups regarding post-exercise IL-6 and CPK were not significant (p>0.05). However, post-exercise LDH in supplementation group were lower than placebo group (p=0.015). In conclusion, short-term supplementation with TT has no effect on IL-6 and hs-CRP, but may be effective on the reduction of muscle damage enzymes CPK and LDH following high-intensity circuit RE.

10
CLINICAL STUDY The American journal of case reports (2024) PMID: 39012853 ↗
Rhabdomyolysis Risk: The Dangers of Tribulus Terrestris, an Over-the-Counter Supplement.
Clinical Trial Synthesis 2024 Clinical Study published in The American journal of case reports. Key conclusion: This may put patients at increased risk of developing serious adverse effects, including rhabdomyolysis and drug-induced liver injury.
View Original PubMed Abstract ↓

BACKGROUND Over-the-counter (OTC) supplement use is a very common practice within the United States. Supplements are not tightly regulated by the Food and Drug Administration. There are many case reports involving OTC supplement adverse effects and medication interactions, but there remains minimal clinical research regarding these subjects. Rhabdomyolysis is one interaction and adverse effect frequently documented in case reports among a variety of OTC supplements, although, to date, there is no documentation of rhabdomyolysis occurring from an interaction between the supplement Tribulus terrestris and atorvastatin. CASE REPORT A 71-year-old man presented to the Emergency Department in rhabdomyolysis with a mild transaminitis after taking the over-the-counter supplement Tribulus terrestris while on long-term atorvastatin. His rhabdomyolysis peaked at day 4 after cessation of the Tribulus and atorvastatin and aggressive fluid resuscitation with a normal saline bolus at admission followed by a D5 sodium bicarbonate drip later transitioned to a normal saline drip with subsequent down-trending of the creatinine phosphokinase levels. CONCLUSIONS Tribulus terrestris is an herbal supplement used for erectile dysfunction and energy. Recent research suggests it to be a moderate CYP 3A4 inhibitor that plays a significant role in metabolism of statin and many other commonly prescribed medications. This may put patients at increased risk of developing serious adverse effects, including rhabdomyolysis and drug-induced liver injury. Screening patients for over-the-counter supplement use and educating them on the potential risks of their use is extremely important for inpatient and outpatient healthcare professionals to avoid dangerous medication interactions.

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