This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive parameters.

开始日期2014-10-01

申办/合作机构

PT Dexa Medica

NCT01733459 / Completed临床3期

The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)

This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with 6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in improving reproductive parameters and to evaluate the safety of DLBS3233 in women with polycystic ovary syndrome compared with metformin, as an active control.

开始日期2013-03-01

申办/合作机构

PT Dexa Medica

NCT01645332 / Completed临床3期

Role of DLBS3233 in the Treatment of Subjects With New Onset of Type 2 Diabetes Mellitus

This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

开始日期2012-07-01

申办/合作机构

PT Dexa Medica

100 项与 DLBS-3233 相关的临床结果

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100 项与 DLBS-3233 相关的转化医学

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项与 DLBS-3233 相关的文献（医药）

2024-07-13·International journal of fertility & sterility

The Efficacy and Safety of DLBS3233, A Combined Bioactive Fraction of Cinnamomum burmanii and Lagerstroemia speciosa Plants on The Endocrine-Metabolic Profile of Women with Polycystic Ovary Syndrome: A Randomized Clinical Trial.

Article

作者: Sumapraja, Kanadi ; Permadi, Wiryawan ; Wiweko, Budi ; Muharam, R ; Tjandrawinata, Raymond R ; Ritonga, Mulyanusa Amarallah ; Hestiantoro, Andon ; Ferrina, Ade Indra ; Djuwantono, Tono

BACKGROUNDA bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa, DLBS3233, has recently been used for type-2-diabetes treatment due to its favorable effect on insulin sensitivity. The insulin resistance leading to metabolic syndrome is closely linked to hyperandrogenemia in polycystic ovary syndrome (PCOS). This study evaluated the metabolic and reproductive efficacy and safety of DLBS3233 in insulin-resistant PCOS women.MATERIALS AND METHODSThis was a 2-arm, randomized, double-blind, controlled, noninferiority clinical study over a 6-month therapy with DLBS3233 100-mg daily in comparison to metformin-XR 750 mg twice daily, involving 124 PCOS women with insulin resistance. The primary efficacy endpoint was the improvement of Homeostasis Model Assessment-Insulin Resistance (HOMA-IR). Secondary endpoints were improvements in other metabolic and reproductive parameters. Safety endpoints were based on blood pressure, heart rate, electrocardiogram findings, liver and renal function, and adverse events.RESULTSAfter 6 months, HOMA-IR improvement in DLBS3233-treated group (-1.03 ± 0.50) and metformin-XR (-1.19 ± 0.50) were comparable, with a between-group difference fell within the pre-set non-inferiority margin (0.16; 95% confidence interval (CI): -1.24, 1.56; P=0.3168). The HOMA-IR in both groups were significantly improved from baseline. On all secondary endpoints, both groups showed comparable effects. Markedly fewer adverse events occurred in the DLBS3233 treated group than in the Metformin-XR-treated group and most were mild clinically and had been resolved by the end of the study.CONCLUSIONTreatment with DLBS3233 100-mg daily in PCOS women demonstrated comparable efficacy to metformin- XR 750-mg twice daily in improving insulin resistance. However, the non-inferiority of DLBS3233 to metformin- XR remains inconclusive. DLBS3233 was more tolerable than metformin-XR (registration number: NCT01733459).

2024-07-01·Acta medica Indonesiana

Effectiveness and Safety of DLBS3233 in Newly Diagnosed Type 2 Diabetes Mellitus: A 12-week Clinical Trial.

Article

作者: Putera, Solomon ; Novitasari, Diana ; Daryanto, Nugroho Agung ; Rombeallo, Lidia ; Reski, Reski ; Nugroho, Heri ; Nurmilawati, Nurmilawati ; Surayya, Intan ; Effendi, Rambu Farah ; Tjandrawinata, Raymond Rubianto

BACKGROUNDDLBS3233, recognized as an agent enhancing insulin sensitivity, has exhibited promise as a therapeutic option for addressing type 2 diabetes mellitus (T2DM). This study aimed to evaluate the effectiveness and safety of DLBS3233, a natural compound, in individuals newly diagnosed with T2DM.METHODSA 12-week double-blind, randomized, placebo-controlled clinical trial was conducted with 104 eligible participants. They were assigned to receive DLBS3233 or a placebo along with lifestyle modifications. Various metabolic parameters, including fasting and post-meal plasma glucose levels at two hours, fasting insulin level, HOMA-IR, adiponectin level, lipid profile, superoxide dismutase (SOD) activity, GLUT-4 concentrations, and body weight measurements, were assessed at baseline, Week 6, and Week 12. Safety parameters assessment will include vital signs, liver function, renal function and adverse event.RESULTSParticipants exhibited similar demographic characteristics in both groups. While no significant changes were noted in fasting plasma glucose and most other parameters, the DLBS3233 group significantly reduced 2-hour postprandial glucose at Week 12 (p = 0.026). There were no substantial differences in A1c levels, fasting insulin, insulin resistance, adiponectin levels, or lipid profiles between the two groups at any point in time. Safety parameters, including blood pressure, liver enzymes, heart rate, gamma GT, and serum creatinine, remained comparable between the groups.CONCLUSIONDLBS3233 showed potential for improving postprandial glucose control in newly diagnosed T2DM individuals. Although significant changes were limited, the study suggests that DLBS3233 could enhance glycemic regulation. The safety evaluation indicated no adverse effects on vital parameters. Further research with larger samples and more prolonged duration is warranted to comprehensively explore DLBS3233's potential in T2DM management.

2023-01-01·International journal of women's health

The Effect and Safety Assessment of Metformin and DLBS3233 (A Bioactive Fraction of Lagerstroemia speciosa and Cinnamomum burmannii) on Improving Metabolic Parameters in Women with Polycystic Ovary Syndrome.

Article

作者: Damas, Suhartono ; Hidayat, Syarief Thaufik ; Tjandrawinata, Raymond R ; Mulyantoro, Inu

BackgroundPolycystic ovary syndrome (PCOS) can lead to compensatory hyperinsulinemia with consequent metabolic abnormalities in women. In this study, DLBS3233 and Metformin were used to be tested. DLBS3233 itself is the new insulin-sensitizing drug, a combination-bioactive-fraction derived from two Indonesian herbals, Lagerstroemia speciosa and Cinnamomum burmannii. DLBS3233 alone and in combination with metformin were evaluated for efficacy and safety in insulin-resistant women with polycystic ovary syndrome (PCOS).MethodsA randomized, double-blind, 3-arm, double-dummy, non-inferiority, and also a controlled clinical study was conducted at the Dr. Kariadi Hospital, Indonesia, between October 2014 and February 2019. The study involved 60 female subjects (with 20 female subjects in each group) that had polycystic ovary syndrome (PCOS).Treatment I consists of one placebo capsule twice per day and one 100 mg DLBS3233 capsule once per day. Treatment II consists of one placebo caplet once per day and one 750 mg Metformin XR caplet twice per day. Treatment III consists of one 750 mg Metformin XR caplet twice per day and one 100 mg DLBS3233 capsule once per day.ResultsIn treatment I, the homeostatic model assessment for insulin resistance (HOMA-IR) levels were 3.55, 3.59, and 3.80 at pretest, 3 months, and 6 months after intervention, respectively. In treatment II, the HOMA-IR level were 4.00, 2.21, and 4.40 at pretest, 3 months, and 6 months after intervention respectively. In treatment III, the HOMA-IR levels were 3.30, 2.86, and 3.12 at pretest, 3 months, and 6 months after intervention, respectively. There was no apparent difference existed in the fasting plasma glucose (FPG), high-density lipoprotein (HDL), triglycerides, ferriman-gallwey scores (FGS), and safety assessment on vital signs and laboratory examinations (liver function and renal function) in all groups.ConclusionEither DLBS3233 alone or the DLBS3233/Metformin combination showed no significant efficacy and did not negatively affect cardiovascular function, liver and kidney function in PCOS subjects.ClinicalTrialsgov IdentifierNCT01999686 Date: 3rd of December, 2013.

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适应症	最高研发状态	国家/地区	公司	日期
胰岛素抵抗	药物发现	印尼	PT Dexa Medica	2014-10-01
多囊卵巢综合征	药物发现	印尼	PT Dexa Medica	2013-03-01
非胰岛素依赖型糖尿病2	药物发现	印尼	PT Dexa Medica	2011-11-01
糖尿病前期	药物发现	印尼	PT Dexa Medica	2011-11-01