NICEVIVA
MONOGRAPH SPEC LATEST 2023

Yellow Dock

BOTANICALS · Evidence Monograph

Yellow Dock is an evidence-graded botanicals monograph evaluated across 9 peer-reviewed PubMed studies (0 meta-analyses, 1 systematic reviews, and 2 randomized controlled trials, encompassing n = 360 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 9 Studies
Meta-Analyses · Reviews 0 Meta · 1 Systematic Reviews
Randomized Trials (RCT) 2 RCTs (1 Double-Blind)
Cumulative Participants n = 360
Reported Trial Dosages 5 g · 3 g · 1 g
Trial Duration Range 1 weeks · 7 days · 14 days
Reading Time ~5 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 9 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (5 g · 3 g · 1 g) over a structured 1 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 (9 PubMed studies)
Quantitative biomarker & outcome analysis (3 studies with effect-size/sample data)
Randomized controlled trial verification (2 RCTs · 1 double-blind)
Systematic review & meta-analysis synthesis (0 meta-analyses · 1 reviews)
01

What Is Yellow Dock & Why Does Form Matter?

Yellow Dock is classified under BOTANICALS and has been investigated across 9 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 (5 g, 3 g, 1 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Yellow Dock 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 (2 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Yellow Dock 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 Yellow Dock an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 9 PubMed studies: 0 meta-analyses, 1 systematic reviews, and 2 randomized controlled trials (1 double-blind, n = 360 total participants).

Representative peer-reviewed findings include: • PMID:35402325 (2022) — "Herbal Teas and Thrombocytopenia: A Curious Case of Yellow Dock and Burdock-Induced Thrombocytopenia." (LEARNING POINTS: Over-the-counter herbal products marketed as having beneficial effects are not always harmless and can have clinically significant side effects.When investigating the causes of thrombocytopenia, physicians should be aware of and search for this rare cause.Treatme) • PMID:31742667 (2020) — "Prevalence of positive reactions in intradermal and IgE serological allergy tests in dogs from South Australia, and the subsequent outcome of allergen-specific immunotherapy." (CONCLUSION: As has been reported in other geographical areas, environmental mites and plant pollens frequently gave positive reactions in allergy tests in South Australia.) • PMID:20623623 (2011) — "Antioxidant activity of yellow dock (Rumex crispus L., Polygonaceae) fruit extract." (crispus extract inhibited CCl(4) -induced oxidative stress by decreasing LPx and increasing GSH content in a dose dependent manner, bringing the levels of antioxidant enzymes to near control values.)

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 5 g · 3 g · 1 g over 1 weeks · 7 days · 14 days · 3 days. 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 Yellow Dock, 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 (5 g · 3 g · 1 g) and re-evaluate efficacy after 1 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 (9 Studies) · 3 Quantitative Analyses

01
CLINICAL STUDY European journal of case reports in internal medicine (2022) PMID: 35402325 ↗
Herbal Teas and Thrombocytopenia: A Curious Case of Yellow Dock and Burdock-Induced Thrombocytopenia.
Clinical Trial Synthesis 2022 Clinical Study published in European journal of case reports in internal medicine. Key conclusion: LEARNING POINTS: Over-the-counter herbal products marketed as having beneficial effects are not always harmless and can have clinically significant side effects.When investigating the causes of thrombocytopenia, physicians should be aware of and search for this rare cause.Treatme
View Original PubMed Abstract ↓

Immune thrombocytopenia (ITP) is a bleeding disorder characterized by a decreased number of platelets. It is an immune system-mediated condition, with formation of antibodies against a structural platelet antigen. Although the pathogenesis remains elusive, primary disease is idiopathic and comprises 80% of cases. However, quite a few secondary causes have been established including Helicobacter pylori, varicella-zoster virus and cytomegalovirus. A few cases with an incidental association with herbal medications have been reported, but this causality has not been studied in detail. Here we present the case of 38-year-old African-American woman who presented with symptomatic thrombocytopenia, with a platelet count of 5 K/μl 1 week after she had consumed herbal tea containing Rumex crispus (yellow dock) and Arctium lappa (burdock). The association between unstudied herbs and ITP needs further research, given the widespread use of these substances and ongoing public uncertainty about their benefits. LEARNING POINTS: Over-the-counter herbal products marketed as having beneficial effects are not always harmless and can have clinically significant side effects.When investigating the causes of thrombocytopenia, physicians should be aware of and search for this rare cause.Treatment for herbal tea-induced thrombocytopenia is the same as for immune thrombocytopenia (i.e., steroids and platelet transfusion if there is actively bleeding). © EFIM 2022.

02
CLINICAL STUDY Australian veterinary journal (2020) PMID: 31742667 ↗
Prevalence of positive reactions in intradermal and IgE serological allergy tests in dogs from South Australia, and the subsequent outcome of allergen-specific immunotherapy.
Clinical Trial Synthesis 2020 Clinical Study published in Australian veterinary journal. Key conclusion: CONCLUSION: As has been reported in other geographical areas, environmental mites and plant pollens frequently gave positive reactions in allergy tests in South Australia.
View Original PubMed Abstract ↓

OBJECTIVE: To determine the prevalence of positive allergen reactions in intradermal and IgE serological tests in dogs presenting to a dermatology referral centre in South Australia and the clinical efficacy of subsequent allergen-specific immunotherapy. DESIGN: Retrospective study. METHODS: Results from 108 intradermal allergy tests, 25 IgE serological assays and immunotherapy outcomes in 37 dogs were retrospectively analysed. Immunotherapy outcomes were determined as excellent, good, modest or failure using a global assessment of efficacy matrix which incorporated pruritus scores, lesion severity, medication requirements, and owner and clinician opinion. RESULTS: The most common positive reactions in intradermal allergy tests were Red clover (59%), Dermatophagoides farinae (29%), Tyrophagus putrescentiae (28%), Yellow dock (25%) and Malassezia pachydermatis (24%). In the IgE serological tests, Yorkshire fog grass (40%), Yellow dock (36%), Kentucky bluegrass (36%) and T. putrescentiae (36%) were the most commonly reported positive results. The outcome of allergen-specific immunotherapy was judged to be excellent in 20% of dogs, good in 15%, modest in 18% and a failure in 47%. CONCLUSION: As has been reported in other geographical areas, environmental mites and plant pollens frequently gave positive reactions in allergy tests in South Australia. However, the prevalence of individual allergen reactions differed between intradermal and IgE serological tests, with M. pachydermatis being identified as a common cause of hypersensitivity in intradermal tests but not in IgE serological assays. Immunotherapy was judged to be a beneficial treatment in 35% of dogs but was essentially unsuccessful in 65%. © 2019 Australian Veterinary Association.

03
CLINICAL STUDY Phytotherapy research (2011) PMID: 20623623 ↗
Antioxidant activity of yellow dock (Rumex crispus L., Polygonaceae) fruit extract.
Clinical Trial Synthesis 2011 Clinical Study published in Phytotherapy research. Key conclusion: crispus extract inhibited CCl(4) -induced oxidative stress by decreasing LPx and increasing GSH content in a dose dependent manner, bringing the levels of antioxidant enzymes to near control values.
View Original PubMed Abstract ↓

The methanol extract of ripe Rumex crispus L. fruits was evaluated for its antioxidant potential by assays for ferric-reducing antioxidant power (FRAP), DPPH-free radical scavenging activity (DPPH) and the influence on lipid peroxidation in liposomes (LP). Considerable activity was observed in all test systems (FRAP: 9.9 mmol Fe(2+) /g; DPPH IC(50) : 3.7 μg/mL; LP IC(50) : 4.9 μg/mL), comparable to that of BHT (FRAP: 8.0 μg/mL; DPPH IC(50) : 19.4 μg/mL; LP IC(50) : 3.5 μg/mL), but lower than the activity of ascorbic acid, rutin and quercetin, used as positive control substances. The in vivo effects were evaluated in several hepatic antioxidant systems (activities of LPx, GSH-Px, Px, CAT and XOD, as well as GSH content), after treatment with the studied yellow dock extract in different doses, or in combination with carbon tetrachloride (CCl(4) ). Pretreatment with the R. crispus extract inhibited CCl(4) -induced oxidative stress by decreasing LPx and increasing GSH content in a dose dependent manner, bringing the levels of antioxidant enzymes to near control values.

04
CLINICAL STUDY Poultry science (2023) PMID: 37523995 ↗
Effects of Rumex nervosus leaf powder supplementation on carcasses compositions, small intestine dimensions, breasts color quality, economic feasibility in broiler chickens.
Clinical Trial Synthesis 2023 Clinical Study published in Poultry science; statistical significance reported at p = 0.05. Key conclusion: The 1 g RNLP/kg feed is the recommended dose to increase productivity and economic profitability ratios per kilogram of meat.
View Original PubMed Abstract ↓

Carcass characteristics, product quality, and the conversion of feed into meat with higher performance and feasibility are important determinants of the profitability and sustainability of any poultry enterprise. The objective of this study was to investigate the potential effect of Rumex nervosus leaf powder (RNLP) on carcass composition, small intestine dimensions, breast color quality, and economic feasibility of Ross broiler chickens. A total of 122 broilers were randomly distributed evenly among 4 treatments (0, 1, 3, and 5 g RNLP/ kg diet, n = 5 replicates per treatment, with 6 broilers per replicate: 3 ♀ and 3 ♂). Performance and economic data were collected in each replicate during the experiment. One male bird from each replication was examined for other criteria on d 34. Results showed that broilers fed 3 g of RNLP had a higher eviscerated carcass weight and dressing percentage (P < 0.05) than the control. The RNLP-fed broilers had higher weights and thicknesses in the duodenum and jejunum of up to 5 g and in the ileum and overall small intestine of up to 3 g. Broilers fed the lowest levels of RNLP had the highest revenue and net gain and the lowest cost-benefit ratio compared with those fed the highest levels of RNLP. The results indicate that the addition of RNLP has a positive effect on carcass processing, the intestinal measurements, and profitability ratios of the broilers. The 1 g RNLP/kg feed is the recommended dose to increase productivity and economic profitability ratios per kilogram of meat.

05
RANDOMIZED TRIAL (RCT) Planta medica (2023) PMID: 34953469 ↗
Microbiological and Clinical Effects of a Proanthocyanidin-enriched Extract from Rumex acetosa in Periodontally Healthy Carriers of Porphyromonas gingivalis: a Randomized Controlled Pilot Study.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Planta medica involving n = 35 participants; statistical significance reported at p = 0.003. Key conclusion: or improve periodontal health following SD.
View Original PubMed Abstract ↓

Rumex acetosa significantly inhibits the adhesion of Porphyromonas gingivalis (P. g.) to eukaryotic host cells in vitro. The objective of this randomized placebo-controlled pilot-trial was to analyze effects of a mouth rinse containing 0.8% (w/w) of a quantified proanthocyanidin-enriched extract from Rumex acetosa (RA1) on microbiological, clinical, and cytological parameters in systemically healthy individuals without history of periodontitis, harboring P. g. intraorally. 35 subjects received a supragingival debridement (SD) followed by mouth rinsing (3 times daily) with either RA1 mouth rinse solution (test) or placebo (control) for 7 days as adjunct to routine oral hygiene. Supragingival biofilm samples were taken at screening visit, baseline (BL), 2, 4, 7 and 14 days after SD. P. g. and 11 other oral microorganisms were detected and quantified by rtPCR. Changes in the oral microbiota composition of one test and one control subject were assessed via high throughput 16S rRNS gene amplicon sequencing. Approximal Plaque Index (API) and the modified Sulcular Bleeding Index (SBI) were assessed at BL, 7- and 14-days following SD. Brush biopsies were taken at BL and 14 d following SD. Intergroup comparisons revealed no significant microbiological, cytological, and clinical differences at any timepoint. However, a significant reduction in SBI at day 14 (p = 0.003) and API at day 7 (p = 0.02) and day 14 (p = 0.009) was found in the test group by intragroup comparison. No severe adverse events were observed. The results indicate that RA1 mouth rinse is safe but does not seem to inhibit colonization of P. g. or improve periodontal health following SD. Thieme. All rights reserved.

06
SYSTEMATIC REVIEW Journal of drugs in dermatology (2019) PMID: 31741361 ↗
Topical Treatments for Melasma: A Systematic Review of Randomized Controlled Trials.
Clinical Trial Synthesis 2019 Systematic Review published in Journal of drugs in dermatology. Key conclusion: Natural compounds are associated with low risk for adverse events, but more research is needed to determine the efficacy, optimal formulation, and appropriate concentration of novel treatments.
View Original PubMed Abstract ↓

Background: Melasma is an acquired skin disease characterized by symmetric hyperpigmentation on sun-exposed areas, particularly on the face. Recently, there has been tremendous scientific interest in novel, safe, and effective topical agents to manage melasma. Objective: To evaluate topical treatments for melasma and provide evidence-based recommendations for clinical use and further research. Methods: We performed a systematic review of randomized controlled trials (RCTs) on topical agents for the treatment of melasma on March 4th, 2019 using PRISMA guidelines. Clinical recommendations were based on the American College of Physicians guidelines. Results: After screening, we identified 35 original RCTs using azelaic acid, cysteamine, epidermal growth factor, hydroquinone (liposomal-delivered), lignin peroxidase, mulberry extract, niacinamide, Rumex occidentalis, triple combination therapy, tranexamic acid, 4-n-butylresorcinol, glycolic acid, kojic acid, aloe vera, ascorbic acid, dioic acid, ellagic acid and arbutin, flutamide, parsley, or zinc sulfate for melasma. Conclusions: Cysteamine, triple combination therapy, and tranexamic acid received strong clinical recommendations for the treatment of melasma. Cysteamine has excellent efficacy and is reported to have anti-cancer properties, but has not been directly compared with hydroquinone. Triple combination agents and tranexamic acid are effective, but carry theoretical risks for ochronosis and thrombosis, respectively. Natural compounds are associated with low risk for adverse events, but more research is needed to determine the efficacy, optimal formulation, and appropriate concentration of novel treatments. J Drugs Dermatol. 2019;18(11):1156-1171.

07
CLINICAL STUDY Ophthalmology (2019) PMID: 30142373 ↗
Natural History of Drusenoid Pigment Epithelial Detachment Associated with Age-Related Macular Degeneration: Age-Related Eye Disease Study 2 Report No. 17.
Clinical Trial Synthesis 2019 Clinical Study published in Ophthalmology involving n = 325 participants; statistical significance reported at p = 0.001 (HR 3.08). Key conclusion: CONCLUSIONS: This study replicates the results of previous natural hist
View Original PubMed Abstract ↓

PURPOSE: To investigate the natural history and genetic associations of drusenoid pigment epithelial detachment (DPED) associated with age-related macular degeneration (AMD). DESIGN: Retrospective analysis of a prospective cohort study. PARTICIPANTS: Of the 4203 Age-Related Eye Disease Study 2 (AREDS2) participants, 391 eyes (325 participants) had DPED without late AMD at the time of DPED detection. Genetic analyses included 120 white AREDS2 participants and 145 Age-Related Eye Disease Study (AREDS) participants with DPED. METHODS: Baseline and annual stereoscopic fundus photographs were graded centrally to detect DPED, a well-defined yellow elevated mound of confluent drusen ≥433 μm in diameter, and to evaluate progression rates to late AMD: geographic atrophy (GA) and neovascular (NV)-AMD. Five single nucleotide polymorphisms (CFH [rs10611670], C3 [rs2230199], CFI [rs10033900], C2/CFB [rs114254831], ARMS2 [rs10490924]) and genetic risk score (GRS) group were investigated for association with DPED development. Kaplan-Meier analyses and multivariable proportional hazard regressions were performed. MAIN OUTCOME MEASURES: Progression rates to late AMD and decrease of ≥3 lines in visual acuity (VA) from the time of DPED detection; association of rate of DPED development with genotype. RESULTS: Mean (standard deviation [SD]) follow-up time from DPED detection was 4.7 (0.9) years. DPED was associated with increased risk of progression to late AMD (hazard ratio [HR], 2.36; 95% confidence interval [CI], 1.98-2.82; P < 0.001); 67% of eyes progressed to late AMD 5 years after DPED detection. Drusenoid pigment epithelial detachment was associated with increased risk of ≥3 lines of VA loss (HR, 3.08; CI, 2.41-3.93; P < 0.001) with 46% of eyes experiencing vision loss at 5 years (with or without progression to late AMD). ARMS2 risk alleles (1 vs. 0: HR, 2.72, CI, 1.58-4.70; 2 vs. 0: HR, 3.16, CI, 1.60-6.21, P < 0.001) and increasing GRS group (4 vs. 1) (HR, 12.17, CI, 3.66-40.45, P < 0.001) were significantly associated with DPED development in AREDS. There were no significant genetic results in AREDS2. CONCLUSIONS: This study replicates the results of previous natural hist

08
RANDOMIZED TRIAL (RCT) International journal of dermatology (2014) PMID: 25265986 ↗
A randomized, double-blind, placebo-controlled clinical trial on the efficacy and safety of 3% Rumex occidentalis cream versus 4% hydroquinone cream in the treatment of melasma among Filipinos.
Clinical Trial Synthesis 2014 Randomized Controlled Trial (RCT) published in International journal of dermatology. Key conclusion: CONCLUSIONS: Rumex occidentalis 3% cream is a safe and effective skin-lightening agent for melasma and is comparable in efficacy with 4% HQ cream.
View Original PubMed Abstract ↓

BACKGROUND: Melasma is a commonly acquired hyperpigmentation symmetrically distributed on the face, neck, and arms. The skin-lightening properties of Rumex occidentalis make it a therapeutic alternative to the reference standard treatment of hydroquinone (HQ). OBJECTIVES: This study was conducted to evaluate the safety and efficacy of 3% R. occidentalis cream versus 4% HQ cream in the management of epidermal and mixed melasma. METHODS: This was a randomized, double-blind, placebo-controlled trial. Forty-five subjects with epidermal and mixed melasma were recruited to compare 3% R. occidentalis cream, 4% HQ cream, and placebo cream applied twice daily for eight weeks. Changes in pigmentation were measured every two weeks using the Melasma Area Severity Index (MASI) and a mexameter. Adverse events were noted on every visit. Patient and investigator global evaluations were performed at the end of the study. RESULTS: Overall mean MASI and mexameter readings in the three groups decreased from baseline to week 8. The greatest decline in score from weeks 2 to 6 was achieved by the HQ group, followed by the R. occidentalis group. By week 8, the R. occidentalis group showed a greater mean ± standard deviation decline in MASI and mexameter readings from baseline (MASI: 0.60 ± 0.86; mexameter: 50.56 ± 25.63) than the HQ group (MASI: 0.55 ± 0.62; mexameter: 45.89 ± 47.83). The efficacy of R. occidentalis cream and HQ cream were assessed as similarly favorable by both study subjects and investigators. CONCLUSIONS: Rumex occidentalis 3% cream is a safe and effective skin-lightening agent for melasma and is comparable in efficacy with 4% HQ cream. © 2014 The International Society of Dermatology.

09
CLINICAL STUDY Rhinology (2012) PMID: 23193534 ↗
Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis.
Clinical Trial Synthesis 2012 Randomized Controlled Trial (RCT) published in Rhinology. Key conclusion: CONCLUSION: The herbal dry extract BNO 1016 is efficacious and well tolerated in patients with acute viral rhinosinusitis.
View Original PubMed Abstract ↓

OBJECTIVE: A herbal drug combination (Dry Extract BNO 1016) has been assessed for efficacy and tolerability in patients with acute viral rhinosinusitis. METHODOLOGY: In this randomised, controlled trial patients with symptom duration of up to 3 days, mild to moderate facial pain and a Major Symptom Score (MSS) between 8 and 12 were treated for 15 days with BNO 1016 or placebo (coated tablets administered orally). Primary efficacy endpoint was mean MSS at end of treatment. Secondary outcome measures included treatment response and changes in paranasal sinuses assessed by ultrasonography. RESULTS: Treatment resulted in clinically relevant, significant differences in mean MSS for BNO 1016 versus placebo. BNO 1016 provided symptom relief two days earlier than placebo. The number needed to treat for healing is 8. BNO 1016 was superior regarding responder rates at Day 10 and Day 14 and percentage of patients without signs of acute viral rhinosinusitis assessed by ultrasonography at end of treatment. BNO 1016 was well tolerated; no serious adverse events were reported. CONCLUSION: The herbal dry extract BNO 1016 is efficacious and well tolerated in patients with acute viral rhinosinusitis. TRIAL REGISTRATION: ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT01146860; EudraCT: 2009-016682-28).

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