Dexa Medica Group

Tangerang, Indonesia

Dexa Medica Group

Tangerang, Indonesia
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Trilaksana N.,Diponegoro University | Riwanto I.,Diponegoro University | Tjandrawinata R.R.,Dexa Medica Group | Winarto R.,Diponegoro University
Asian Pacific Journal of Tropical Biomedicine | Year: 2017

Objective: To prove the molecular mechanisms of Mahkota Dewa (Phaleria macrocarpa) in suppressing proliferation of human retinoblastoma cells through suppression of cell cycle's gene-regulators expression. Methods: In this study, the molecular mechanism of anti-tumor effect of fractioned extract of Phaleria macrocarpa (DLBS1425) in human retinoblastoma cells Y-79 was investigated by measuring the number of tumor cells viability, the assessment of population profiles of tumor cells in the cell cycle, and the mRNA concentration of p16, p21, p53, cyclin D, cyclin E, and E2F. Results: DLBS1425 showed an inhibition effects towards proliferation of Y-79 cell line. Inhibition of proliferation was shown by suppression of cell cycle progression. DLBS1425 downregulated cyclin E, a G1 phase regulator gene of cell cycle, in dose-dependent manner without affecting p53-p21 pathway. In the other word, DLBS1425 inhibits cell proliferation through suppression of cyclin E independently towards conventional proliferation pathway. Conclusions: Our results suggest that DLBS1425 is a potential anticancer agent which targets genes involved in cell proliferation in human retinoblastoma cells which make it pharmacologically ideal for the prevention and/or treatment of retinoblastoma cancer. © 2017 Hainan Medical University.

PubMed | PT Equilab International Jakarta and Dexa Medica Group
Type: Journal Article | Journal: Drug research | Year: 2016

This study was aimed to evaluate the safety and tolerability of Lumbrokinase DLBS1033 in healthy adult subjects.This was a 2-arm, randomized, double-blind, placebo-controlled, cross-over study over 14 days of treatment with DLBS1033 490mg 3 times daily. Eligible subjects were enrolled at Period 1 and allocated to receive either test drug or placebo, and underwent a clinical assessment including vital signs, electrocardiography, laboratory examination (hemostasis parameters, routine hematology, liver and renal function), the presence of hemorrhagic symptoms and allergic reactions. Afterwards, they went on to a 2-week washout period, and then were crossed-over to receive the alternate drug at Period 2. The procedure of Period 1 was repeated in the same manner with the alternate drug at Period 2.Of 20 subjects enrolled, one subject was lost to follow-up on Evaluation Day-14 of Period 2. Bleeding risk was relatively low as demonstrated by insignificant differences in hemostasis parameters between DLBS1033 and Placebo. Neither were there significant differences between DLBS1033 and Placebo in terms of hematological parameter, each blood chemistry parameter (liver function, renal function, lipid profile, fasting blood glucose), abnormality proportions of urine test, stool occult blood, and ECG interpretation. There were no hemorrhagic symptoms (petechiae, epistaxis, hematoma) and allergic reactions encountered by study subjects during the treatment with DLBS1033 and Placebo.DLBS1033 given at the dose of 490mg 3 times daily was safe and tolerable in healthy adults.

Susalit E.,University of Indonesia | Agus N.,University of Indonesia | Effendi I.,University of Indonesia | Tjandrawinata R.R.,Dexa Medica Group | And 5 more authors.
Phytomedicine | Year: 2011

A double-blind, randomized, parallel and active-controlled clinical study was conducted to evaluate the anti-hypertensive effect as well as the tolerability of Olive leaf extract in comparison with Captopril in patients with stage-1 hypertension. Additionally, this study also investigated the hypolipidemic effects of Olive leaf extract in such patients. It consisted of a run-in period of 4 weeks continued subsequently by an 8-week treatment period. Olive (Olea europaea L.) leaf extract (EFLA ®943) was given orally at the dose of 500 mg twice daily in a flat-dose manner throughout the 8 weeks. Captopril was given at the dosage regimen of 12.5 mg twice daily at start. After 2 weeks, if necessary, the dose of Captopril would be titrated to 25 mg twice daily, based on subject's response to treatment. The primary efficacy endpoint was reduction in systolic blood pressure (SBP) from baseline to week-8 of treatment. The secondary efficacy endpoints were SBP as well as diastolic blood pressure (DBP) changes at every time-point evaluation and lipid profile improvement. Evaluation of BP was performed every week for 8 weeks of treatment; while of lipid profile at a 4-week interval. Mean SBP at baseline was 149.3 ± 5.58 mm Hg in Olive group and 148.4 ± 5.56 mm Hg in Captopril group; and mean DBPs were 93.9 ± 4.51 and 93.8 ± 4.88 mm Hg, respectively. After 8 weeks of treatment, both groups experienced a significant reduction of SBP as well as DBP from baseline; while such reductions were not significantly different between groups. Means of SBP reduction from baseline to the end of study were -11.5 ± 8.5 and -13.7 ± 7.6 mm Hg in Olive and Captopril groups, respectively; and those of DBP were -4.8 ± 5.5 and -6.4 ± 5.2 mm Hg, respectively. A significant reduction of triglyceride level was observed in Olive group, but not in Captopril group. In conclusion, Olive (Olea europaea) leaf extract, at the dosage regimen of 500 mg twice daily, was similarly effective in lowering systolic and diastolic blood pressures in subjects with stage-1 hypertension as Captopril, given at its effective dose of 12.5-25 mg twice daily. © 2010 Elsevier GmbH. All rights reserved.

Tjandrawinata R.R.,Dexa Medica Group | Suastika K.,Udayana University | Nofiarny D.,Dexa Medica Group
International Journal of Diabetes and Metabolism | Year: 2012

DLBS3233 is a standardized extract combination of two Indonesian herbals (Lagerstroemia speciosa L. and Cinnamomum burmanii L.) developed by a patented extraction-technology. DLBS3233 has been proven pre-clinically to have a glucose lowering activity. This Phase 1 clinical study evaluated the safety of DLBS3233 in comparison with the negative-control and pioglitazone 30 mg (active control) in healthy volunteers. In this randomized, open-labeled, Latin-square-designed clinical study consisting of 7 groups of treatment, DLBS3233 capsules were given at doses of 50, 100, 200, 300, 400 mg in each group, respectively. The Active Control group received pioglitazone 30 mg and the Negative Control did not receive any study drug. All study drugs were administered once daily for three days prior to the conduct of 75 g glucose oral loading at each study course. Wash-out period between each course was one week. Safety parameters were blood glucose profile, liver and renal functions, and adverse events. Six healthy volunteers with a mean age of 27.8 ± 6.1 years old were enrolled in the study. The result demonstrated comparable blood glucose profiles between all groups indicating that both DLBS3233 and pioglitazone do not exert a hypoglycemic effect in non-obese healthy subjects with normoglycemia. DLBS3233 treatment did not affect liver and kidney function. Neither did it cause any serious adverse events. Overall, this study demonstrated the low risk of DLBS3233 to induce hypoglycemia and that the extract was safe and well tolerated.

Setyopranoto I.,Gadjah Mada University | Wibowo S.,Gadjah Mada University | Tjandrawinata R.R.,Dexa Medica Group
Asian Journal of Pharmaceutical and Clinical Research | Year: 2016

Objectives: This clinical study was conducted to determine the hemostasis profile and clinical outcome of acute ischemic stroke patients treated with DLBS1033 in comparison with aspirin or clopidogrel. DLBS1033 is a proprietary bioactive protein fraction derived from the earthworms (Lumbricus rubellus) that possesses both fibrinolytic and antithrombotic properties. Methods: This was a 3-arm, parallel, randomized, controlled, open-label, blinded-evaluation study involving 126 acute ischemic stroke patients. Each subject received any of the following study medication within 96 hrs after the stroke onset: Aspirin 80 mg daily (Group 1), or clopidogrel 75 mg daily (Group 2), DLBS1033 490 mg 3 times daily (Group 3), for 90 days. Hemostasis parameters evaluated were prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR), while the clinical outcomes were measured using Gadjah Mada Stroke Scale (SSGM) and Barthel index (BI). Results: Baseline characteristics, including the hemostasis and clinical profiles, were comparable between groups. At the end of the study, PT, aPTT, and INR values were not significantly different between groups, which were all within the normal ranges. There was a significant improvement of BI as well as SSGM from baseline in each group. The improvement size of BI was found similar between groups (p=0.098). However, a significantly better improvement of SSGM was observed in those received DLBS1033 (6.98±4.90; p=0.001 vs. aspirin [3.74±3.66], p=0.006 vs. clopidogrel [4.26±4.21]). Conclusion: It was concluded that DLBS1033 provided a safe hemostasis profile (PT, aPTT, and INR) comparable to that of aspirin or clopidogrel in ischemic stroke patients. Treatment with DLBS1033 improved clinical outcomes indicated by the BI and SSGM, and the improvement size of SSGM was even better than that of aspirin or clopidogrel treatment. © 2016, Asian Journal of Pharmaceutical and Clinical Research. All rights reserved.

Nailufar F.,Dexa Medica Group | Tandrasasmita O.M.,Dexa Medica Group | Tjandrawinata R.,Dexa Medica Group
Biomedicine and Preventive Nutrition | Year: 2011

DLBS3233 is a standardized extract combination containing Lagerstroemia speciosa and Cinnamomum burmannii. The effect on glucose uptake, adiponectin secretion, and insulin signaling of DLBS3233 (1-5μg/ml) was examined in this study. 3T3 Swiss albino preadipocytes and adipocytes were used to investigate gene expressions which were detected using reverse transcription PCR method. DLBS3233 was found to enhance the expression of genes associated with increased insulin signaling and sensitivity such as PPARγ and PPARδ. In addition, the expressions of PI3 kinase, Akt, as well as GLUT4 genes were seen to be increased. This extract combination also increased glucose uptake, increased adiponectin secretion, and decreased resistin secretion significantly relative to control cells. Moreover, DLBS3233 administered in insulin resistant Wistar strain rats (Rattus norvegicus strain Wistar), showed a property to control blood glucose, insulin and cholesterol levels. Therefore, DLBS3233 is a promising combination of herbal extracts which conveys medical utilities in term of type II diabetes treatment, and, possibly also in diabetes disease prevention. © 2011 Elsevier Masson SAS.

Kartolo D.,Sam Ratulangi University | Suparman E.,Sam Ratulangi University | Tjandrawinata R.R.,Dexa Medica Group | Susanto L.W.,Dexa Medica Group
Asian Journal of Pharmaceutical and Clinical Research | Year: 2016

Objective: DLBS3233, a new insulin sensitizing agent for Type 2 diabetes, is a combination-bioactive-fraction derived from two herbs, i.e., Lagerstroemia speciosa and Cinnamomum burmannii. Since insulin resistance plays a central pathogenic role in polycystic ovary syndrome (PCOS), DLBS3233 has the potential to benefit women with such a condition, in whom menstrual irregularity, chronic anovulation or infertility are manifested. This clinical study was performed to evaluate the clinical efficacy of DLBS3233 as a single pharmacological therapy in improving follicle maturity in women with PCOS measured by a transvaginal ultrasonography (USG). Methods: The open study enrolled 14 PCOS subjects from the Obstetrics and Gynecology Department of Sam Ratulangi University/Prof. Dr. Kandou Hospital, satellite hospitals, and private practices. Patients were measured for the dominant follicle diameter using transvaginal USG. Subjects were given DLBSS3233 capsule at a dose of 1 capsule at 100 mg once daily for 30 days of the treatment. At the end of the study, patients’ follicle diameters were re-assessed. The difference in follicle diameters was compared within the group (within-subject) by paired t-test, with a significance level (α) of 0.05. Results: Among 14 PCOS enrolled subjects, 57.2% aged between 26 and 30 years old. There were similar proportions of subjects with normal body mass index (42.8%) and overweight(42.8%). Before treatment (at baseline), the mean follicle diameter was 4.094±1.016 mm. After 30 days of treatment, it increased significantly to 8.594±1.647 mm (p<0.001 versus baseline). There were 10 subjects (71.4%) showed follicles with size ranging between 5 and 10 mm, while the remaining 4 subjects (28.6%) had them bigger than 10 mm. Conclusion: Through this study, DLBS3233 at the dose of 100 mg once daily for 30 days showed a potential benefit for PCOS patients, particularly in improving follicle maturity expressed as an increased follicular diameter. © 2016, Asian Journal of Pharmaceutical and Clinical Research. All rights reserved.

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