scholarly journals Pterostilbene on Metabolic Parameters: A Randomized, Double-Blind, and Placebo-Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Daniel M. Riche ◽  
Krista D. Riche ◽  
Chad T. Blackshear ◽  
Corey L. McEwen ◽  
Justin J. Sherman ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Weight Loss ◽  
Total Cholesterol ◽  
Mixed Models ◽  
Controlled Trial ◽  
Metabolic Parameters ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind ◽  
Over Time

Introduction. The purpose of this trial was to evaluate the effect of pterostilbene on metabolic parameters.Methods. A prospective, randomized, double-blind, and placebo-controlled study that enrolled 80 patients with a total cholesterol ≥200 mg/dL and/orLDL≥100 mg/dL. Subjects were divided into four groups: (1) pterostilbene 125 mg twice daily; (2) pterostilbene 50 mg twice daily; (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily; (4) matching placebo twice daily for 6–8 weeks. Endpoints included lipids, blood pressure, and weight. Linear mixed models were used to examine and compare changes in parameters over time. Models were adjusted for age, gender, and race.Results. LDL increased with pterostilbene monotherapy (17.1 mg/dL;P=0.001) which was not seen with GE combination (P=0.47). Presence of a baseline cholesterol medication appeared to attenuate LDL effects. Both systolic (−7.8 mmHg;P<0.01) and diastolic blood pressure (−7.3 mmHg;P<0.001) were reduced with high dose pterostilbene. Patients not on cholesterol medication (n=51) exhibited minor weight loss with pterostilbene (−0.62 kg/m2;P=0.012).Conclusion. Pterostilbene increases LDL and reduces blood pressure in adults. This trial is registered with Clinicaltrials.govNCT01267227.

Abstract 617: Impact Of Pterostilbene On Blood Pressure and Other Metabolic Parameters In Adults

Hypertension ◽  
2012 ◽  
Vol 60 (suppl_1) ◽  
Author(s):  
Daniel M Riche ◽  
David Deschamp ◽  
Michael E Griswold ◽  
Corey L McEwen ◽  
Krista D Riche ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Reproductive Potential ◽  
Metabolic Parameters ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind ◽  
Tract Disease ◽  
Cholesterol Therapy ◽  
Fibric Acids ◽  
Over Time

Objective: Pterostilbene is a polyphenol that is chemically related to resveratrol and commonly found in berries, such as blueberries. The purpose of this trial was to evaluate the effect of pterostilbene on metabolic parameters. METHODS: The trial was a prospective, randomized, double-blind, placebo-controlled study of patients with a total cholesterol ≥200 mg/dL and/or LDL ≥100 mg/dL. Patients were included if they were ≥18 years old and on either no cholesterol therapy or cholesterol medication at a stable dose for at least 2 months prior to baseline laboratory. Patients were excluded if they had significant hepatic, renal or GI tract disease or current overt cardiovascular disease; were receiving thiazolidinediones or fibric acids; were women who were pregnant or of reproductive potential. Eighty subjects were divided equally into one of four groups: (1) pterostilbene 125 mg twice daily; (2) pterostilbene 50 mg twice daily; (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily; (4) matching placebo twice daily for 6-8 weeks. Patients received identical counseling on lifestyle intervention. Metabolic endpoints included blood pressure, body weight, and lipids. Linear mixed models were used to examine changes in metabolic parameters over time within treatment groups and compare changes over time across groups. Models were adjusted for age, sex and race. Results: The majority of patients completed the study (73/80; 91%). The average age was 54 years. The majority of patients were female (57/80; 71%), Caucasian (56/80; 70%), and had HTN (44/80; 55%). Both systolic (-7.8 mmHg; p<0.01) and diastolic blood pressure (-7.3 mmHg; p<0.001) were reduced with high dose pterostilbene. The only change in lipids was an increase in LDL with pterostilbene monotherapy (24.9 mg/dL; p<0.001) which was not seen with GE combination (p=0.47). Presence of a baseline cholesterol medication appeared to attenuate LDL effects. Patients not on cholesterol medication (n=51) exhibited minor weight loss with pterostilbene (-0.59 kg/m2; p=0.014). Conclusion: Pterostilbene reduces blood pressure in adults. Future studies should evaluate high dose pterostilbene with GE in a hypertensive population. Clinicaltrials.gov identifier NCT 01267227.

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

2021 ◽  
Author(s):  
xiaochen Yang ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
Hongzheng Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome ◽  
And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

A phase 3, multicenter, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT).

2014 ◽  
Vol 32 (18_suppl) ◽  
pp. LBA6008-LBA6008 ◽  
Author(s):  
Martin Schlumberger ◽  
Makoto Tahara ◽  
Lori J. Wirth ◽  
Bruce Robinson ◽  
Marcia S. Brose ◽  
...  
Keyword(s):  
Weight Loss ◽  
Thyroid Cancer ◽  
Adverse Events ◽  
Differentiated Thyroid Cancer ◽  
Kinase Inhibitor ◽  
Controlled Trial ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

LBA6008 Background: Lenvatinib (LEN) is an oral tyrosine kinase inhibitor of the VEGFR1-3, FGFR1-4, PDGFRβ, RET, and KIT signaling networks. Based on efficacy results of the phase 2 study of patients (pts) with 131I-refractory differentiated thyroid cancer (RR-DTC), this phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT) was developed. Methods: This randomized, double-blind, placebo (PBO)-controlled study enrolled pts with RR-DTC with documented disease progression within 13 months (mo). Pts were stratified by age (≤65, >65 years), region and ≤1 prior VEGFR-targeted therapies and randomized 2:1 to LEN or PBO (24mg/d, 28-d cycle). Upon progression, pts receiving PBO could crossover to open-label LEN. The primary endpoint was PFS assessed by Independent Radiologic Review; secondary endpoints included overall response rate (ORR; complete response [CR] + PR), overall survival (OS) and safety. Results: 392 pts (63.0 years median age; 51.0% male) were randomized. Pts on LEN had a significantly prolonged PFS vs PBO (hazard ratio 0.21, 95% confidence interval [CI] 0.14–0.31; P <.0001); median PFS was LEN: 18.3 mo (95% CI 15.1–not evaluable), PBO: 3.6 mo (95% CI 2.2–3.7). A LEN PFS benefit was observed in all predefined subgroups; median LEN PFS for pts with prior vs no prior VEGF-therapy was 15.1 mo (n=66) and 18.7 mo (n=195), respectively. Rates (n) of CRs were LEN: 1.5% (4), PBO: 0; PRs were LEN: 63.2% (165), PBO: 1.5% (2).Median exposure duration was LEN: 13.8 mo, PBO: 3.9 mo; median time to LEN response was 2.0 mo. Median OS has not been reached; deaths per arm were LEN: 71 (27.2%), PBO: 47 (35.9%). The 5 most common LEN treatment-related adverse events (TRAEs; any grade) were hypertension (68%), diarrhea (59%), appetite decreased (50%), weight loss (46%), nausea (41%). LEN grade ≥3 TRAEs (≥5%) were hypertension (42%), proteinuria (10%), weight loss (10%), diarrhea (8%), appetite decreased (5%). The dose was reduced in 78.5% of pts and discontinued due to adverse events (AEs) in 14.2% of pts. Conclusions: LEN significantly improved PFS compared with PBO in pts with progressive RR-DTC. There were no unexpected toxicities and AEs were manageable. Clinical trial information: NCT01321554.

Combination Oral Antioxidant Supplementation Reduces Blood Pressure

1997 ◽  
Vol 92 (4) ◽  
pp. 361-365 ◽  
Author(s):  
Helen F. Galley ◽  
Judith Thornton ◽  
Peter D. Howdle ◽  
Barry E. Walker ◽  
Nigel R Webster
Keyword(s):  
Blood Pressure ◽  
Sodium Succinate ◽  
Controlled Study ◽  
High Dose ◽  
Antioxidant Supplementation ◽  
Short Term ◽  
Double Blind ◽  
Increased Risk ◽  
Hypertensive Therapy ◽  
Β Carotene

1. Hypertension affects 30% of adults and low intakes of antioxidants have been associated with increased risk of hypertension and cardiovascular disease. To investigate the effect of short-term high-dose antioxidant supplementation on blood pressure in hypertensive and normotensive outpatients, we undertook a randomized, double-blind, crossover design placebo-controlled study. 2. Forty subjects were recruited from medical outpatient clinics, of whom 38 completed the study. Twenty-one were attending for treatment of hypertension and 17 were normotensive, attending for minor gastrointestinal complaints. Subjects were randomly assigned to receive either 8 weeks placebo followed by 2 weeks washout then 8 weeks antioxidants or vice versa. The combination of antioxidants consisted of 200 mg of zinc sulphate, 500 mg of ascorbic acid, 600 mg of α-tocopherol (sodium succinate salt) and 30 mg of β-carotene daily. 3. Systolic blood pressure fell at the end of the antioxidant phase compared with the placebo phase both in subjects receiving anti-hypertensive therapy (P < 0.01) and those who were normotensive (P = 0.067). Circulating levels of β-carotene and α-tocopherol increased in all subjects during supplementation (P < 0.01) and urine nitrite increased in hypertensive patients (P < 0.05). 4. Short-term oral high-dose combination antioxidant therapy reduces blood pressure, possibly via increased availability of nitric oxide. This study may have implications for the innovative use of antioxidants as an adjunct to anti-hypertensive therapy.

scholarly journals Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Ralf Uebelhack ◽  
Udo Bongartz ◽  
Stephanie Seibt ◽  
Gordana Bothe ◽  
Pee Win Chong ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Placebo Group ◽  
Body Fat ◽  
Dose Group ◽  
Low Dose ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
High Dose ◽  
Double Blind

Objective. This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults. Methods. A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual’s energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study. Results. After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p<0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p<0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported. Conclusions. These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.

scholarly journals Effects of 7-day supplementation with escalating doses of citrulline nitrate on resting and post-exercise blood pressure and safety biomarkers in healthy men: A randomized controlled trial

2021 ◽  
Vol 5 ◽  
pp. 239784732110386
Author(s):  
Nikola Todorovic ◽  
Valdemar Stajer ◽  
Laszlo Ratgeber ◽  
Jozsef Betlehem ◽  
Pongras Acs ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Controlled Trial ◽  
High Dose ◽  
Double Blind ◽  
Post Exercise ◽  
Hematological Indices ◽  
Healthy Men ◽  
Exercise Blood Pressure ◽  
Medium Dose ◽  
Apparently Healthy

We investigated the effects of 7-day supplementation with three different dosages of citrulline nitrate (CN) on blood pressure at rest and after exercise, biochemical safety markers, and self-reported outcome measures of adverse events in healthy men. 12 apparently healthy young men (age 25.9 ± 4.0 years; weight 78.6 ± 10.0 kg, height 181.0 ± 7.0 cm) volunteered to participate in this double-blind, randomized, placebo-controlled cross-over trial. The dosages of CN were 1.5 g per day (low dose), 3.0 g per day (medium dose), and 6.0 g per day (high dose). No significant differences were found for systolic and diastolic blood pressure and heart rate at rest and after exercise between varying doses of CN and placebo ( p > 0.05). In addition, hematological indices, biochemical variables, and clinical enzyme profiles were not affected by either intervention ( p > 0.05), and the type and frequency of side effects were comparable to the placebo group. Citrulline nitrate was safe and well tolerated when administered for 7 days in dosages up to 6 g per day.

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium-risk hypertensive patients: study protocol for a randomized double-blind controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Xiaochen Yang ◽  
Lanping Liu ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome

Abstract Introduction Hypertension is one of the most important risk factors for cardiovascular disease, and its control rates remain low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) could suppress ventricular hypertrophy and inflammatory responses, lower blood pressure, and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension. Methods and analysis This trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experimental group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is the change in 24-h average systolic and diastolic blood pressure. The secondary outcomes include heart rate variability, pharmacogenomic evaluation, improvement in TCM syndrome, and serum pro-inflammatory/anti-inflammatory cytokines between the two groups. The safety of medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0. Ethics and dissemination This study has been approved by the Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial, and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. Discussion We hypothesize that patients with low-to-medium-risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration Chinese Clinical Trial Registry ChiMCTR1900002876. Registered in November 2019

Effects of Angiotensin II on Insulin Sensitivity: A Placebo-Controlled Study

1993 ◽  
Vol 85 (4) ◽  
pp. 431-436 ◽  
Author(s):  
A. D. Morris ◽  
J. R. Petrie ◽  
J. Anderson ◽  
J. M. C. Connell ◽  
R. Donnelly
Keyword(s):  
Blood Pressure ◽  
Insulin Sensitivity ◽  
Angiotensin Ii ◽  
Enzyme Inhibitor ◽  
Serum Insulin ◽  
Whole Body ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind ◽  
Plasma Angiotensin

1. There is evidence that hyperinsulinaemia increases the aldosterone response to angiotensin II, and that angiotensin-converting enzyme inhibitor drugs enhance peripheral glucose utilization, but the direct effects of angiotensin II on insulin sensitivity have not been reported previously. 2. In a randomized, double-blind, placebo-controlled, cross-over study, 12 healthy male subjects attended on 3 study days for the evaluation of the effects of a subpressor (1 ng min−1 kg−1) and pressor (5 ng min−1 kg−1) infusion of angiotensin II on whole-body insulin sensitivity using the euglycaemic hyperinsulin-aemic clamp. Frequent measurements of blood pressure and heart rate were recorded and blood samples were collected for determination of serum insulin, C-peptide and K+ concentration, plasma renin activity and plasma angiotensin II concentration. 3. Plasma angiotensin II concentrations (means +SD) were 11+5 pg/ml after placebo, and 27+9 and 125+28 pg/ml after low and high dose angiotensin II, respectively. The higher dose of angiotensin II was associated with significant increases in blood pressure (e.g. 13 mmHg systolic blood pressure at 150 min) and serum aldosterone concentration. Whole-body insulin sensitivity was 10.5 + 2 mg of glucose min−1 kg−1 after placebo, and 10.5 +2.2 and 10.9+3.4 mg of glucose min−1 kg−1 after low and high dose angiotensin II (not significant). 4. Angiotensin II had no effect on hyperinsulinaemia-induced reductions in serum potassium and triacyl-glycerol concentrations. 5. Thus, acute infusion of angiotensin II for 3 h, with or without an increase in blood pressure, has no effect on whole-body insulin sensitivity.

scholarly journals The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Mostafa Qorbani ◽  
Milad Sanginabadi ◽  
Mohammad Reza Mohajeri-Tehrani ◽  
Sara Karimi ◽  
Hadis Gerami ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Metabolic Parameters ◽  
Sex Hormone Binding Globulin ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Specific Serum

BackgroundA double blind clinical trial was performed to evaluate whether the polycystic ovary syndrome (PCOS)-specific serum markers and metabolic parameters would change in the women with PCOS during the three-month administration of oligopin.MethodsIn this double-blind multicenter trial, we randomly assigned 80 PCOS women, based on a 1:1 ratio, to receive oligopin (n= 40) or maltodextrin as placebo (n = 40) for up to 3 months. As PCOS-specific outcomes, we investigated the changes in testosterone, sex hormone binding globulin (SHBG), free androgen index (FAI), dehydroepiandrosterone (DHEA), follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Secondary end points were metabolic (fasting glycaemia, hemoglobin A1c (HbA1c), lipids, insulin resistance (HOMA-IR)), anthropometrics parameters and blood pressure from the baseline to the end of treatment. We investigated serum transaminase, alkaline phosphatase (ALP), creatinine (Cr) and blood urea nitrogen (BUN) levels as hepatic and kidney outcomes, respectively.ResultsThe first participant was enrolled on April 18, 2018, and the last study visit took place on May 14, 2019. PCOS-specific serum parameters did not change during the three-month administration of oligopin (p &gt; 0.05), except for a small increase in the FSH levels (p=0.03). Oligopin neither changed the metabolic profile nor the anthropometric parameters or blood pressure. ALP levels was significantly increased in placebo group, as compared with oligopin (p=0.01).ConclusionOligopin supplementation does not seem to be exerting a beneficial effect on both hormonal and metabolic parameters in the women with PCOS.Clinical Trial Registrationwww.irct.ir, identifier IRCT20140406017139N3.

A Randomized, Placebo-Controlled Study to Evaluate the Effect of Bio-Enhanced Turmeric Formulation on Radiation-Induced Oral Mucositis

ORL ◽  
2021 ◽  
pp. 1-11
Author(s):  
Tej Prakash Soni ◽  
Anil Kumar Gupta ◽  
Lalit Mohan Sharma ◽  
Harish Singhal ◽  
Shantanu Sharma ◽  
...  
Keyword(s):  
Weight Loss ◽  
Oral Cancer ◽  
Oral Mucositis ◽  
Controlled Trial ◽  
Controlled Study ◽  
High Dose ◽  
Oral Pain ◽  
Oral Cancer Patients ◽  
Grade 3 ◽  
The Impact

<b><i>Introduction:</i></b> Oral mucositis is the most common toxicity of chemoradiotherapy treatment of head and neck cancers. The present study was performed to evaluate the effect of a researched turmeric formulation on oral mucositis in patients receiving chemoradiotherapy for oral cancer. <b><i>Methods:</i></b> This randomized double-blinded placebo-controlled trial included 60 patients with oral cancer who had undergone radical surgery. Patients were equally randomized into 3 arms. Bio-enhanced turmeric formulation (BTF) capsules (low dose [1 g/day] or high dose [1.5 g/day]) or placebo was administered daily for 6 weeks with concurrent chemoradiotherapy. Study endpoints included the impact of the treatment on chemoradiotherapy-induced oral mucositis along with dysphagia, oral pain, dermatitis, and weight loss. <b><i>Results:</i></b> The incidence of grade 3 toxicity of oral mucositis, oral pain, dysphagia, and dermatitis was significantly lower in patients who received BTF than placebo. Twenty-five and 20% patients in BTF 1 g/day (<i>p</i> = 0.011) and 1.5 g/day (<i>p</i> = 0.004) arms, respectively, developed grade 3 oral mucositis compared to 65% patients in the placebo arm. Thirty-five and 30% patients in BTF 1 g/day (<i>p</i> = 0.027) and 1.5 g/day (<i>p</i> = 0.011) arms, respectively, developed grade 3 oral pain compared to 70% patients in the placebo arm. Twenty-five and 20% patients in BTF 1 g/day (<i>p</i> = 0.025) and 1.5 g/day (<i>p</i> = 0.010) arms, respectively, developed grade 3 dysphagia compared to 60% patients in the placebo arm. Ten and 5% patients in BTF 1 g/day (<i>p</i> = 0.114) and 1.5 g/day (<i>p</i> = 0.037) arms. respectively, developed grade 3 dermatitis compared to 30% patients in the placebo arm. Patients under BTF supplementation experienced significantly less weight loss and greater compliance with treatment than placebo. <b><i>Conclusion:</i></b> BTF (BCM-95®) can significantly reduce chemoradiotherapy-induced severe oral mucositis, dysphagia, oral pain, and dermatitis in oral cancer patients. <b><i>Trial Registration:</i></b> Clinical Trials Registry, India (Registration No. CTRI) (CTRI/2015/12/006413 dated December 4, 2015).

Sign in / Sign up

Export Citation Format

Share Document