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Efficacy and safety of HT080 for lower urinary tract symptoms associated with benign prostatic hyperplasia: A study protocol for a randomized, double-blind, placebo-controlled trial.
Medicine (Baltimore). 2019 Nov; 98(45):e17848.M

Abstract

BACKGROUND

Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) are one of the most common conditions seen in middle-aged and elderly men and threaten their quality of life. Since conventional pharmacotherapy for LUTS/BPH can lead to sexual side effects, herbal therapies are widely used as complementary and alternative treatments worldwide. HT080 is an herbal extract of Cinnamomum cassia and Rosa Laevigata, both of which have been used to treat symptoms typically associated with BPH in traditional Asian medicine. The aims of this trial are to assess whether HT080 can alleviate LUTS/BPH in middle-aged and elderly men, and to investigate the safety of HT080.

METHODS/DESIGN

A double-blind, randomized, placebo-controlled, two-arm parallel group trial will be conducted in men with moderate LUTS/BPH. A total of 100 eligible men aged 40 to 75 years with an International Prostate Symptom Score of 8 to 19 will be randomized in a 1:1 ratio and receive either HT080 (500 mg) or placebo twice a day for 12 weeks. All participants will be evaluated for efficacy and safety at baseline and weeks 6 and 12. The primary endpoint is the change in International Prostate Symptom Score between baseline and week 12. The secondary efficacy variables are uroflowmetry parameters (maximal urinary flow rate and post-void residual volume), serum prostate-specific antigen, testosterone, and dihydrotestosterone levels, the International Index of Erectile Function score, and participant-reported global response assessment scores. The safety assessments include adverse events, laboratory tests results, vital signs, and physical examination.

DISCUSSION

This is a first-in human trial designed to investigate the efficacy and safety of HT080 among middle-aged and elderly men with LUTS/BPH. This prospective study with a double-blind randomized design will provide high-quality evidence supporting the use of HT080 for LUTS/BPH.

TRIAL REGISTRATION

Korean Clinical Research Information Service (KCT0004286) Registered September 6, 2019.

Authors+Show Affiliations

Department of Herbal Pharmacology, Kyung Hee University College of Korean Medicine, 26 Kyungheedae-ro, Dongdaemun-gu.Department of Urology, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.Department of Herbal Pharmacology, Kyung Hee University College of Korean Medicine, 26 Kyungheedae-ro, Dongdaemun-gu.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31702643

Citation

Song, Jungbin, et al. "Efficacy and Safety of HT080 for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: a Study Protocol for a Randomized, Double-blind, Placebo-controlled Trial." Medicine, vol. 98, no. 45, 2019, pp. e17848.
Song J, Lee SH, Kim H. Efficacy and safety of HT080 for lower urinary tract symptoms associated with benign prostatic hyperplasia: A study protocol for a randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2019;98(45):e17848.
Song, J., Lee, S. H., & Kim, H. (2019). Efficacy and safety of HT080 for lower urinary tract symptoms associated with benign prostatic hyperplasia: A study protocol for a randomized, double-blind, placebo-controlled trial. Medicine, 98(45), e17848. https://doi.org/10.1097/MD.0000000000017848
Song J, Lee SH, Kim H. Efficacy and Safety of HT080 for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: a Study Protocol for a Randomized, Double-blind, Placebo-controlled Trial. Medicine (Baltimore). 2019;98(45):e17848. PubMed PMID: 31702643.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of HT080 for lower urinary tract symptoms associated with benign prostatic hyperplasia: A study protocol for a randomized, double-blind, placebo-controlled trial. AU - Song,Jungbin, AU - Lee,Seung Hwan, AU - Kim,Hocheol, PY - 2019/11/9/entrez PY - 2019/11/9/pubmed PY - 2019/11/21/medline SP - e17848 EP - e17848 JF - Medicine JO - Medicine (Baltimore) VL - 98 IS - 45 N2 - BACKGROUND: Lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) are one of the most common conditions seen in middle-aged and elderly men and threaten their quality of life. Since conventional pharmacotherapy for LUTS/BPH can lead to sexual side effects, herbal therapies are widely used as complementary and alternative treatments worldwide. HT080 is an herbal extract of Cinnamomum cassia and Rosa Laevigata, both of which have been used to treat symptoms typically associated with BPH in traditional Asian medicine. The aims of this trial are to assess whether HT080 can alleviate LUTS/BPH in middle-aged and elderly men, and to investigate the safety of HT080. METHODS/DESIGN: A double-blind, randomized, placebo-controlled, two-arm parallel group trial will be conducted in men with moderate LUTS/BPH. A total of 100 eligible men aged 40 to 75 years with an International Prostate Symptom Score of 8 to 19 will be randomized in a 1:1 ratio and receive either HT080 (500 mg) or placebo twice a day for 12 weeks. All participants will be evaluated for efficacy and safety at baseline and weeks 6 and 12. The primary endpoint is the change in International Prostate Symptom Score between baseline and week 12. The secondary efficacy variables are uroflowmetry parameters (maximal urinary flow rate and post-void residual volume), serum prostate-specific antigen, testosterone, and dihydrotestosterone levels, the International Index of Erectile Function score, and participant-reported global response assessment scores. The safety assessments include adverse events, laboratory tests results, vital signs, and physical examination. DISCUSSION: This is a first-in human trial designed to investigate the efficacy and safety of HT080 among middle-aged and elderly men with LUTS/BPH. This prospective study with a double-blind randomized design will provide high-quality evidence supporting the use of HT080 for LUTS/BPH. TRIAL REGISTRATION: Korean Clinical Research Information Service (KCT0004286) Registered September 6, 2019. SN - 1536-5964 UR - https://www.unboundmedicine.com/medline/citation/31702643/Efficacy_and_safety_of_HT080_for_lower_urinary_tract_symptoms_associated_with_benign_prostatic_hyperplasia:_A_study_protocol_for_a_randomized_double_blind_placebo_controlled_trial_ L2 - http://dx.doi.org/10.1097/MD.0000000000017848 DB - PRIME DP - Unbound Medicine ER -