Safety, Effectiveness, and Cost-effectiveness of an Herbal Medicine, Gongjin-dan, in Subjects With Chronic Dizziness: a Prospective, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Clinical Trial

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group, clinical trial to explore the effectiveness of an herbal medication, Gongjin-dan (GJD) for chronic dizziness (Ménière disease, psychogenic dizziness, or dizziness of unknown cause), identified as liver-deficiency pattern/syndrome, and assessed with Dizziness Handicap Inventory (DHI) ≥ 24 at baseline. Participants will be randomized and allocated to either GJD or placebo group with 1:1 ratio and orally administered GJD or placebo pills once a day for 8 weeks. For collecting data for cost-effectiveness analysis, the participants will be followed up to 12 months from randomization.

Start Date01 Apr 2018

Sponsor / Collaborator

Kyung Hee University

100 Clinical Results associated with Gongjin-Dan

100 Translational Medicine associated with Gongjin-Dan

100 Patents (Medical) associated with Gongjin-Dan

Literatures (Medical) associated with Gongjin-Dan

01 Sep 2018·Chinese Journal of Integrative Medicine

Suppression of Oxidative Stress of Modified Gongjin-Dan (WSY-1075) in Detrusor Underactivity Rat Model Bladder Outlet Induced by Obstruction

Article

Author: Jung, Jin-Woo ; Yoon, Byung Il ; Kim, Su Jin ; Jeon, Seung Hwan ; Chung, Mun Su ; Kim, Sae Woong ; Ha, U Syn ; Bae, Woong Jin ; Choi, Sae Woong ; Hwang, Sung Yeoun

OBJECTIVETo investigate the anti-oxidative stress and preventive effect of modified Gongjin-dan (WSY-1075) in a detrusor underactivity rat model.METHODSRats were randomly allocated to three groups: shamoperated (control), bladder outlet obstruction-induced detrusor underactivity (BOO-DU), and BOO-DU with WSY-1075 (WSY) groups. WSY-1075 was orally administrated to rats 200 mg daily for 2 weeks prior to the operation and 4 weeks after the operation. Bladder outlet obstruction was surgically induced in rats by ligation around the urethra avoiding total obstruction. Cystometrography was conducted on rats in each group for examination of bladders.RESULTSCompared with the control group, bladder outlet obstruction led to a significant increase in oxidative stress with consequent changes to molecular composition, and decrease in maximal detrusor pressure (P<0.05). WSY-1075 treatment significantly suppressed oxidative stress and prevented degenerative and dysfunctional changes in bladder, as compared with BOO-DU group (P<0.05).CONCLUSIONWSY-1075 had beneficial effect on prevention of BOO-DU.

01 Jan 2017·Evidence-Based Complementary and Alternative MedicineQ4 · MEDICINE

A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double‐Blind, Placebo‐Controlled, Parallel‐Group, Clinical Trial for Effectiveness, Safety, and Cost‐Effectiveness

Q4 · MEDICINE

ArticleOA

Author: Kim, Jinyoung ; Shin, Mi-Ran ; Yi, Gilhee ; Shin, Seungwon ; Yu, Ami ; Lee, Euiju ; Seo, Hyung-Sik ; Cho, Jae-Heung ; Hong, Seung-Ug

This study protocol aims to explore the effectiveness, safety, and cost‐effectiveness of a herbal medication, Gongjindan (GJD), in patients with chronic dizziness. This will be a prospective, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, clinical trial. Seventy‐eight patients diagnosed with Meniere’s disease, psychogenic dizziness, or dizziness of unknown cause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g GJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale) and frequency of dizziness, balance function (Berg Balance Scale), fatigue (Fatigue Severity Scale) and deficiency pattern/syndrome (qi blood yin yang‐deficiency questionnaire) levels, and depression (Korean version of Beck’s Depression Inventory) and anxiety (State‐Trait Anxiety Inventory) levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the incremental cost‐effectiveness ratio will be calculated based on quality‐adjusted life years (from the EuroQoL five dimensions’ questionnaire) and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two‐sided). This trial is registered with ClinicalTrials.gov NCT03219515, in July 2017.

01 Jan 2017·Toxicology LettersQ2 · MEDICINE

The anti-hyperplasia, anti-oxidative and anti-inflammatory properties of Qing Ye Dan and swertiamarin in testosterone-induced benign prostatic hyperplasia in rats

Q2 · MEDICINE

Article

Author: Li, Lun ; Gu, Ye ; Wu, Xinying

Qing Ye Dan (QYD) is the whole plant of Swertia mileensis and used in Chinese folk medicine for the treatment of prostatitis, benign prostatic hyperplasia (BPH) and so on. This study was to investigate the effects of QYD and its main component swertiamarin on BPH induced by testosterone in rats. The prostatic expressions of vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), basic fibroblast growth factor (βFGF) and proliferating cell nuclear antigen (PCNA) were detected by immunohistochemistry assay. Prostatic levels of oxidative stress and inflammatory-related factors were also analyzed. Additionally, the prostatic expressions of androgen receptor (AR), estrogen receptor (ER)-α, ER-β, hypoxia-inducible factor (HIF)-1α, B-cell CLL/lymphoma (Bcl)-2 and Bcl-2-associated X protein (Bax) were measured by western blot. The epithelial-mesenchymal transition (EMT) associated factors were evaluated by quantitative RT-PCR. It showed that QYD and swertiamarin ameliorated the testosterone-induced prostatic hyperplasia and collagen deposition, attenuated the over-expressions of HIF-1α, VEGF, EGF, βFGF, PCNA, AR and ER-α, reduced the ratio of Bcl-2/Bax, enhanced the expression of ER-β, inhibited the oxidative stress and local inflammation, as well as relieved prostatic EMT. It suggested that QYD and swertiamarin had prostatic protective potential against BPH.

100 Deals associated with Gongjin-Dan

R&D Status

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Indication	Country/Location	Organization	Date
Asthenia	KR	Kyungbang Pharm Co. Ltd.	28 Aug 2000
Dizziness	KR	Kyungbang Pharm Co. Ltd.	28 Aug 2000
Fatigue Syndrome, Chronic	KR	Kyungbang Pharm Co. Ltd.	28 Aug 2000
Headache	KR	Kyungbang Pharm Co. Ltd.	28 Aug 2000
Menstruation Disturbances	KR	Kyungbang Pharm Co. Ltd.	28 Aug 2000
Fatigue	KR	-	-
Fatigue	CN	-	-

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