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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100 项与 DLBS-3233 相关的专利（医药）

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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).

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.

2021-01-01·Journal of Human Reproductive Sciences

Administration of cinnamon and lagersroemia speciosa extract on lipid profile of polycystic ovarian syndrome women with high body mass index

Article

作者: Hestiantoro, Andon ; Iswari, Wulan Ardhana ; Ritonga, Mulyanusa Amarullah ; Wiweko, Budi ; Permadi, Wiryawan ; Ferrina, Ade Indri ; Djuwantono, Tono ; Muharram, Raden ; Tjandrawinata, Raymond ; Sumapraia, Kanadi

BACKGROUNDHyperinsulinemia, a common feature in PCOS, have been found to contribute to metabolic disturbance, such as dyslipidaemia and diabetes mellitus type 2. Oral anti-diabetic medications have been prescribed to alleviate this effect. We sought to fnd whether DLBS3233, an insulin sensitizer, could alleviate dyslipidaemia in women with PCOS with high BMI.AIMThis study aimed to investigate the effect of DLBS3233, an herbal combination of C burmanii and L spesiosa extract, on lipid profle, insulin resistance, and free testosterone of women with PCOS with high BMI.STUDY SETTING AND DESIGNThis was a controlled trial conducted in Dr. Cipto Mangunkusumo Hospital, Jakarta, and Dr Hasan Sadikin Hospital, Bandung, Indonesia.MATERIALS AND METHODSA controlled trial was conducted on 62 volunteers diagnosed with PCOS according to Rotterdam criteria and exhibited insulin resistance as signifed by HOMA-IR > 2.0; baseline lipid profile (LDL, HDL, Triglyceride and Total cholesterol) and free testosterone concentration were obtained. Participants were given 100 mg of DLBS3233 in the morning, and volunteers were followed up monthly, with laboratory tests conducted at the third and sixth months. Data were analysed through intention-to-treat analysis, separating high BMI (≥25 kg/m2) subjects.STATISTICAL ANALYSISRepeated-measures model.RESULTSDLBS3233 improved lipid profle and insulin sensitivity by reducing triglycerides, HOMA-IR, and free testosterone in subjects with high BMI. Limitations and Implications: The current study does not compare the effect of DLBS3233 with a control group. A larger study with a proper control group would have to be conducted to have more conclusive results.CONCLUSIONThis study showed that DLBS3233 holds promise as a novel therapy to improve lipid profle for women with PCOS.

100 项与 DLBS-3233 相关的药物交易

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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