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Effectiveness and Safety Profile of Ginkgo biloba Standardized Extract (EGb761®) in Patients with Amnestic Mild Cognitive Impairment.
Băjenaru, O, Prada, G, Antochi, F, Jianu, C, Tudose, C, Cuciureanu, A, Docu, AA, Perrot, V, Avram, M, Tiu, C
CNS & neurological disorders drug targets. 2021;(4):378-384
Abstract
BACKGROUND Ginkgo biloba is a common symptomatic treatment for cognitive impairment, although data on its efficacy are controversial. OBJECTIVE The aim of the current study was to evaluate the effectiveness of standardized Ginkgo biloba extract EGb761® (Tanakan®) for the improvements of cognitive functions over 24 months in a local cohort of patients diagnosed with amnestic mild cognitive impairment (aMCI). METHODS This multicentre non-interventional study included 500 eligible patients with a MCI treated with 120 mg/day standardized Ginkgo biloba extract EGb761® (Tanakan®). Patients were evaluated using several scales for assessment of cognition, memory, activities of daily living, and depression (MMSE, FAQ, CGI, HAM-D) at baseline and every 6 months after that for a 24-month period. The median change in MMSE at the 24-month follow-up was the primary outcome of the study. RESULTS A statistically significant increase of 2 points in the median MMSE score was obtained. In patients with other concomitant cognitive disorders, the improvement in MMSE was less significant. Tanakan® improved memory impairment (using the delayed recall test) and the ability to accomplish activities of daily living (mean FAQ score, 1.7); it also decreased the severity of depression (mean HAM-D score, 2.4) at the end of the study. More than 80% of the patients showed minimal improvement of their condition as assessed by the CGI-Improvement Scale. CONCLUSION The administration of EGb761® (Tanakan®) led to a significant improvement of cognitive decline, memory, activities of daily living, and depression in subjects with aMCI over 24 months.
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HL301 versus Umckamin in the treatment of acute bronchitis: a phase III, randomized, controlled, double-blind, multicenter study.
Kim, WY, Park, MJ, Rhee, CK, Lee, SY, Kim, DJ, Kim, DG, Choi, CM, Kim, DK, Kim, YH, Yoon, HJ, et al
Current medical research and opinion. 2020;(3):503-508
Abstract
Objective: HL301 is a combination product of seven medicinal plants that has been proven effective in acute bronchitis by two phase II studies. In the present study, its efficacy and safety compared with those of Umckamin in the treatment of acute bronchitis were evaluated in phase III, randomized, controlled, double-blind, multicenter trial design.Methods: A total of 246 acute bronchitis patients were randomized to receive either HL301 (600 mg/day) or Umckamin (333 mg/day) for seven days. The primary outcome was the difference in their baseline (visit 2) and end of treatment (visit 3) bronchitis severity score (BSS). Other efficacy variables included the change in each BSS component (cough, sputum, dyspnea, chest pain, and crackle), response rate, improvement rate, and satisfaction rate with treatment.Results: A full analysis set and per protocol set analysis of both groups revealed that the difference of BSS between visit 2 and visit 3 in the HL301 and Umckamin group was not significantly different (4.58 ± 1.79 versus 4.29 ± 1.88, p = .37 and 4.60 ± 1.81 versus 4.33 ± 1.88, p = .42, respectively). The change in five BSS components (cough, sputum, dyspnea, chest pain, and crackle) of the HL301 and Umckamin groups did not differ after treatment. HL301 or Umckamin treated participants showed an equal level of response, improvement, and satisfaction rates with treatment. Both the HL301 group and Umckamin group showed the same safety profile.Conclusions: HL301 (600 mg/day) was as effective and safe as Umckamin (333 mg/day) in treating acute bronchitis.
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Rationale and design to assess the efficacy and safety of HT047 in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase II trial.
Heo, SH, Song, J, Kim, BJ, Kim, H, Chang, DI, ,
Medicine. 2019;(43):e17655
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Abstract
BACKGROUND Though several neuroprotective agents have been evaluated as potential treatments for acute ischemic stroke, none have demonstrated a definitive treatment efficacy, which remains elusive. HT047 is an herbal extract of Scutellaria baicalensis and Pueraria lobata, both of which have been widely used to treat ischemic stroke in traditional Korean medicine. The aims of this trial are to investigate whether HT047 can improve neurologic status, particularly motor function, in acute ischemic stroke patients, and to determine the safety of HT047. METHODS A multicenter, double-blind, randomized, placebo-controlled, 3-arm parallel group, phase II trial will be conducted in patients who have had an acute ischemic stroke within the past 14 days. The participating patients must have a Fugl-Meyer assessment (FMA) motor score ≤55, with arm or leg weakness, and Korean version of the National Institutes of Health Stroke scale (K-NIHSS) score of ≥4 and ≤15. Seventy-eight participants will be randomized in a 1:1:1 ratio and given high-dose HT047 (750 mg 3 times a day), low-dose HT047 (500 mg 3 times a day), or a placebo for 12 weeks. The primary endpoint is the change in FMA motor score between baseline and week 12. Secondary endpoints are as follows: the change in FMA motor score at weeks 4 and 8 from baseline; the change in FMA motor score at weeks 4, 8, and 12 from baseline according to the timing of treatment initiation (either within 1 week, or 1-2 weeks), or according to the presence of prognostic risk factors (hypertension, diabetes, dyslipidemia, etc); the change in K-NIHSS and Korean versions of the modified Rankin scale (K-mRS) and the modified Barthel index at weeks 4 and 12 from baseline; and the proportion of subjects at week 12 with a K-NIHSS score of 0 to 2, or with K-mRS scores of 0, ≤1, and ≤2. DISCUSSION This study is a 1st-in-human trial of HT047 to explore the efficacy and safety in acute ischemic stroke patients. The results will provide the appropriate dosage and evidence of therapeutic benefit of HT047 for stroke recovery. TRIAL REGISTRATION ClinicalTrials.gov (NCT02828540) Registered July 11, 2016.
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Efficacy of a Lupinus mutabilis Sweet snack as complement to conventional type 2 diabetes mellitus treatment.
Fornasini Salvador, MV, Abril-Ulloa, SV, Beltrán Carreño, JP, Villacrés, E, Cuadrado-Merino, L, Robalino, F, Sánchez, R, Ricaurte Ortiz, PS, Muñoz, EB, Benítez Loza, NB, et al
Nutricion hospitalaria. 2019;(4):905-911
Abstract
Introduction: therapeutic lifestyles changes including frequent consumption of legumes have resulted in improved metabolic control and decreased blood pressure in type 2 diabetes-mellitus (T2DM) patients. Objective: this was a quasi-experimental-28-week crossover-study that assessed the effect of daily consumption of the legume Lupinus mutabilis (LM) on metabolic control of T2DM patients under hypoglycemic oral treatment. Material and methods: we recruited 79 adult male and female patients that were followed for 14-weeks without LM consumption and then received increasing doses of a LM-based-snack for other 14-weeks. Results: there was a significant decrease in blood pressure and a significant increase in HDL-cholesterol by the end of the study period. While patients with A1C concentrations > 8 and ≤ 10 did not significantly improve their metabolic control, patients with serum A1C concentrations ≤ 8.0% reduced significantly their A1C after the intervention and 71% achieved a target concentration of 6.5%. Conclusion: patients with T2DM could benefit with the addition of LM-snack to their conventional treatment.
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[Action of Calendula officinalis essence on bone preservation after the extraction].
Uribe-Fentanes, LK, Soriano-Padilla, F, Pérez-Frutos, JR, Veras-Hernández, MA
Revista medica del Instituto Mexicano del Seguro Social. 2018;(1):98-105
Abstract
BACKGROUND Calendula officinalis is a phytodrug used as analgesic, antiseptic and wound-healing agent due to its collagenogenic effect, which is why it is a convenient and affordable treatment that promotes alveolar bone preservation after tooth extraction in vivo. The aim of this study was to use Calendula officinalis during and after tooth extraction to determine its ability to preserve bone after this procedure. METHODS We established two groups matched by age, gender and position of the third molar. We used with patients on the experimental group Calendula officinalis diluted 10% as an irrigant during surgical extraction of third molars. We performed the conventional way with the control group irrigating with saline solution. Subsequently, both groups continued to make mouthwash for a week with the irrigating agent. Every week for a month, each patient underwent periapical radiography, out of which we took measurements of alveolar ridges and depth of alveolar bone, which were compared. CONCLUSIONS There is statistically significant evidence to state that Calendula officinalis favorably affects bone preservation after extraction.
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Efficacy of an Ayurvedic Formulation for Mild-to-moderate Osteoarthritis: A Phase 3, Randomized Controlled Study.
Modak, MD, Barde, MP
Alternative therapies in health and medicine. 2017;(1):26-33
Abstract
Context • Current treatment options offer only symptomatic pain relief for patients with osteoarthritis (OA). Thus, a need exists for effective treatment of the disability-causing disease. The proprietary polyherbal formulation, Nartana, has been used for several years for OA. Objective • The study intended to compare the benefits of the herbal formulation with those of routinely used nonsteroidal anti-inflammatory drugs (NSAIDs) for patients with mild-to-moderate OA. Design • The research team designed a phase 3, double-blind, double-dummy, randomized controlled study. Setting • The study was conducted at 2 hospital sites in Pune, India. Participants • The participants were 80 outpatients with OA at the hospitals. Intervention • The participants were randomly assigned to receive either the intervention (herbal formulation) or the active control (diclofenac) for 12 wk. The herbal formulation group received 450 mg of Nartana capsule and diclofenac-matching placebo. Treatment was given 2 ×/d for first 15 d and then 1 ×/d until the end of the study. The control group received 50 mg of diclofenac tablet 2 ×/d for first 15 d and then 100 mg of diclofenac tablet 1 ×/d and a Nartana-matching placebo until end of the study. Outcome Measures • To measure efficacy, the study used the modified Center for Rheumatic Diseases Pune version of the Western Ontario and McMaster Universities OA index (WOMAC) and the Health Assessment Questionnaire (HAQ). The study also measured overall perceived pain relief. The primary outcome measure was the change in the combined WOMAC score from baseline to postintervention (12 wk). Safety and other efficacy measures were the secondary end points. Results • The herbal formulation and diclofenac groups matched well at baseline for demographic profile, disease status, and WOMAC scores. The combined WOMAC scores were significantly reduced from baseline to postintervention for both groups (P < .01). The earliest significant reduction was seen at week 4 (P < .01) and persisted at subsequent visits (P < .01). Similar changes were also seen in the WOMAC subscales-pain, stiffness, and physical function or difficulty in performing routine activities-and HAQ scores. Similar changes were also seen in the WOMAC subscales-pain, stiffness, and physical function or difficulty in performing routine activities-and HAQ scores. Improvement was also observed with perceived pain relief. Overall, the efficacy of the herbal formulation was not inferior to the diclofenac. Related adverse events were generally mild to moderate in nature and were resolved with or without symptomatic treatment. Conclusions • For patients with mild-to-moderate OA, Nartana significantly reduced joint pain, stiffness, and physical function; improved quality of life; and provided pain relief. The herbal formulation's efficacy was not inferior to routinely prescribed diclofenac. The drug should be explored further in large long-term comparative studies as an alternative to NSAIDs.
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Myoxinol ointment for the treatment of acute fissure.
Martellucci, J, Rossi, G, Corsale, I, Carrieri, P, D'Elia, M, Giani, I
Updates in surgery. 2017;(4):499-503
Abstract
Myoxinol is a complex of oligopeptides obtained from the seeds of Hibiscus esculentus used in cosmetic as natural alternative to botulin toxin. The aim of the study was to evaluate the safety and effectiveness of local myoxinol for the treatment of acute anal fissure. All the consecutive patients with acute fissure treated from January to June 2014 underwent 30 days of topical treatment (twice/day) with a mioxinol based ointment. Pain, symptomatic relief, fissure healing and re-epithelization, 1-year recurrence rate, subjective satisfaction and need for further treatments were evaluated. During the study period 157 patients were eligible for data analysis (91 males: 58%; mean age 38 years: range 17-83). Median anal pain score was 7.1 pre-treatment and 1.7 and 0.9 after 30 days and 12 months from treatment, respectively (p: 0.0001). After the treatment period complete healing was achieved in 103 patients (65.5%), relevant improvement in 31 (20%) and no improvement in 21 patients (13.5%). Overall efficacy rate was 85.5%. A significant difference was reported considering patients with pre-treatment VAS between 1-5 and 6-10 (p: 0.004). Twenty-nine patients (18.5%) required further treatments. Hydrolyzed Hibiscus esculentus extract was proven to be an effective and well-tolerated topical treatment for acute fissure, with a high healing rate, a significant reduction of pain and a low 1-year recurrence rate.
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Efficacy and safety of HL301 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis: a phase 2, randomized, double-blind, placebo-controlled, multicenter study.
Park, MJ, Rhee, CK, Kim, YH, Kim, DJ, Kim, DG, Lee, SY, Kim, JY
Current medical research and opinion. 2017;(5):919-925
Abstract
PURPOSE The efficacy and safety of Chinese herbs for symptomatic treatment of bronchitis is not well established. We evaluated the efficacy and safety of a combination product of seven herbs (HL301) for the treatment of acute bronchitis (AB) and acute exacerbation of chronic bronchitis (AECB) using a randomized, double-blind, placebo-controlled, multicenter trial design. METHODS A total of 160 patients with AB or with AECB were randomized to receive placebo or one of three doses of HL301 (0.6 g/day, 1.2 g/day, or 1.8 g/day) for a total of 7 days. The primary study endpoint was the change in bronchitis severity score (BSS) from the baseline visit (visit 2) to the end of treatment visit (visit 3). Other efficacy variables were percentage BSS systemic sign efficacy after treatment and change in individual BSS parameters after treatment. FINDINGS Changes in BSS from visit 2 to visit 3 in the three treatment groups (4.63 ± 2.24, 4.08 ± 1.63, and 4.15 ± 1.74 in the HL301 0.6 g/day, 1.2 g/day, and 1.8 g/day groups, respectively) were higher than that of the placebo group (2.88 ± 2.57) in the per protocol set (PPS) (P < .05), and it was also valid in the full analysis set (FAS). The number of participants whose symptoms (measured by BSS) improved at least 30% after treatment was higher in all three treatment groups compared to the placebo group in both the FAS and the PPS (P < .05, for all). IMPLICATIONS Three different doses of HL301 (0.6 g/day, 1.2 g/day, and 1.8 g/day) were effective in decreasing the BSS index compared to placebo. HL301 may be effective for symptomatic treatment of both AB and AECB. LIMITATIONS Essential components of HL301 have not been delineated in the study and patients with AB and AECB were indiscriminately enrolled in the present study. Respective evaluation of the efficacy of HL301 for AB and AECB will be necessary in the future.
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Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer.
Marucci, L, Farneti, A, Di Ridolfi, P, Pinnaro, P, Pellini, R, Giannarelli, D, Vici, P, Conte, M, Landoni, V, Sanguineti, G
Head & neck. 2017;(9):1761-1769
Abstract
BACKGROUND There is no widely accepted intervention in the prevention of acute mucositis during chemoradiotherapy for head and neck carcinoma. In the present double-blind study, we tested 4 natural agents, propolis, aloe vera, calendula, and chamomile versus placebo. METHODS Patients undergoing concomitant chemo-intensity-modulated radiotherapy (IMRT) were given natural agent or matched placebo; grade 3 mucositis on physical examination according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was the primary endpoint. Various covariates were tested at logistic regression, including the individual amount of mucosa receiving at least 9.5 Gy per week (V9.5w). RESULTS One hundred seven patients were randomized from January 2011 to July 2014, and 104 were assessable (51%-49% were assigned to the placebo group and 53%-51% were assigned to the natural agent). Overall, 61 patients developed peak grade 3 mucositis with no difference between arms (P = .65). Conversely, V9.5w (P = .007) and primary site (P = .037) were independent predictors. CONCLUSION The selected natural agents do not prevent mucositis, whereas the role of V9.5w is confirmed.
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Treatment of ichthyosis lamellaris using a series of herbal skin care products family.
Tirant, M, Bayer, P, Hercogovấ, J, Fioranelli, M, Gianfaldoni, S, Chokoeva, AA, Tchernev, G, Wollina, U, Novotny, F, Roccia, MG, et al
Journal of biological regulators and homeostatic agents. 2016;(2 Suppl 3):65-72
Abstract
Lamellar ichthyosis (LI) is a genetically heterogeneous group of disorders of keratinization that are inherited in an autosomal recessive fashion, occurring in approximately 1 in 300,000 live births. The treatment of the large, dark, plate-like scales that characterize the classic manifestation of the disease are still a challenge. The aim of this study was to evaluate the efficacy and tolerability of Dr. Michaels® skin-care products for the management of LI. A multi-centre European prospective study was conducted, including 10 patients (3 female/7 male) with lamellar ichthyosis, aged 38-54 years old (mean age: 46). Each patient had been treated with emollients plus other different systemic therapies, such as corticosteroids, Cyclosporin A or retinoids in the past. All patients were treated with Dr Michaels® product family including both topical and oral herbal supplements. The topical treatments used were the cleansing gel, activator formula and ointment. The oral medications were PSC 200, PSC 400 and PSC 900. Within 3 weeks of initiation of treatment, there were improvements observed on the skin including a reduction in scaling, fissuring, and intensity in erythema and pruritus with thinning of the hyperkeratotic plate. After 12-15 weeks, most of the plates and scales had been removed to reveal a normalised skin colour. Evidence of hair, eyelash and eyebrow growth was observed. There was partial nail resolution with a reduction in subungual hyperkeratosis. No adverse reactions were observed. Our patients showed excellent symptomatic response to treatment within a 14-week period, follow-up by an on-going regular assessment on a quarterly basis. The results show that Dr Michaels® product family is an effective and safe treatment option for LI.