This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for the treatment of pain in patients suspected endometriosis. It is hypothesized that the reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen, is significantly greater than that of Control. In addition, the administration of DLBS1442 at higher dose also results in significantly greater reduction than that of DLBS1442 at lower dose and of Control.

开始日期2015-10-01

申办/合作机构

PT Dexa Medica

100 项与 DLBS-1442 相关的临床结果

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100 项与 DLBS-1442 相关的转化医学

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100 项与 DLBS-1442 相关的专利（医药）

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项与 DLBS-1442 相关的文献（医药）

2022-05-01·Recent Advances in Inflammation & Allergy Drug Discovery

Anti-inflammatory Effect of Predimenol, A Bioactive Extract from Phaleria macrocarpa, through the Suppression of NF-κB and COX-2

Article

作者: Tandrasasmita, Olivia M ; Tjandrawinata, Raymond R ; Yuliana, Yurike

Background:Inflammation is the response to the reaction of any type of bodily injury by elevating cellular metabolism and releasing soluble mediators. It is also a contributing factor of pain. Predimenol, which has previously been known as DLBS1442, is a bioactive extract from Phaleria macrocarpa (Scheff.) Boerl (Thymelaceae). It can be an alternative treatment for pain relief, especially for long-term use.Objective:The objective of this study is to evaluate the anti-inflammatory activities of predimenol through the evaluation of several parameters involved in the inflammatory pathway.Methods:Cyclooxygenase 2 (COX-2), inducible nitric oxide synthase (iNOS), tumor necrosis factor- α (TNF-α), interleukin-1β (IL-1β), interleukin-2 (IL-2), interleukin-6 (IL-6), and nuclear factor κB (NF-κB) were observed after 24 h exposure of predimenol (0-180 μg/mL) to lipopolysaccharides (LPS)-activated RAW 264.7 cell. The inflammatory markers were measured using nitric oxide (NO) assay and enzyme-linked immunosorbent assay (ELISA) for COX-2 inhibitor assay. The gene expressions of TNF-α, IL-1β, IL-2 and IL-6 were quantified using the polymerase chain reaction (PCR) method. Western blotting was applied to detect phosphorylated IκB kinase (IKK) protein to confirm the activation of NF-κB.Results:Our study showed a similar mechanism with most non-steroidal anti-inflammatory drugs (NSAIDs). Predimenol consistently downregulated the expression of iNOS and inhibited COX-2 activity. Moreover, predimenol significantly inhibited the LPS-induced production of NO, TNF-α, IL-1β, IL-2 and IL-6. Down-regulation of these markers was suggested due to the reduction of NF- κB transcription level and activation by predimenol.Conclusion:Predimenol exhibits anti-inflammatory activities through NF-kB inactivation-mediated COX-2 suppression, which may suggest that predimenol is a potential analgesic and anti-inflammatory agent.

International Journal of Women's Health4区 · 医学

Anti-inflammatory, antiangiogenic, and apoptosis-inducing activity of DLBS1442, a bioactive fraction of Phaleria macrocarpa, in a RL95-2 cell line as a molecular model of endometriosis

4区 · 医学

ArticleOA

作者: Tjandrawinata, Raymond R ; Arifin, Poppy F ; Sutanto, Adeline M ; Tandrasasmita, Olivia M

DLBS1442 is a bioactive fraction extracted from the fruit of the native Indonesian plant, Phaleria macrocarpa (Scheff.) Boerl (Thymelaceae). This bioactive fraction is a potential treatment for dysmenorrhea and endometriosis. The present study investigated the pharmacological action of DLBS1442 in endometrial cells. The effect of various doses of DLBS1442 (0-200 μg/mL) over 24 hours was studied using the human endometrial RL95-2 cell line to observe its effect on angiogenesis, cell migration, estrogen and progesterone receptor levels, the eicosanoid pathway, cell viability, and apoptosis. The impact of DLBS1442 on nuclear factor kappa B (NFκB) and the eicosanoid pathway was also studied through its marker gene expression using a quantitative real-time polymerase chain reaction method. DLBS1442 showed an ability to inhibit angiogenesis and cell migration in a dose-dependent manner. At a dose of 100 μg/mL, DLBS1442 increased the cell population in sub-G1 phase from 7% to 34%. DLBS1442 also significantly downregulated the estrogen receptor level and upregulated the progesterone receptor level. Further, it inhibited the eicosanoid signaling pathway by reducing the NFκB transcription level and subsequent reduction of inducible nitric oxide synthase. A dose-dependent decrease in viability and increased apoptosis in RL95-2 cells were also evident after exposure to DLBS1442, where the IC50 was obtained at around 100 μg/mL. In conclusion, DLBS1442 is a potential agent for alleviating symptoms of endometriosis via its antiangiogenic, anti-inflammatory, and proapoptotic activity.

International Journal of General Medicine4区 · 医学

Symptomatic treatment of premenstrual syndrome and/or primary dysmenorrhea with DLBS1442, a bioactive extract of Phaleria macrocarpa

4区 · 医学

ArticleOA

作者: Susanto, Liana W ; Nofiarny, Dwi ; Tjandrawinata, Raymond R ; Hendri, Prihatini ; Clarissa, Audrey

BACKGROUNDDLBS1442, a proprietary and standardized semipolar bioactive extract of the fruit Phaleria macrocarpa, is preclinically proven to have anti-inflammatory properties. The current clinical study evaluated the efficacy and safety of DLBS1442 in alleviating symptoms of premenstrual syndrome and primary dysmenorrhea.METHODSThis was an open study over four menstrual cycles (with two control cycles, followed by two treatment cycles). Women with premenstrual syndrome and/or primary dysmenorrhea, 18-40 years of age, and with a regular menstrual cycle were included in the study. In the treatment cycles, DLBS1442 extract was given as a 100 mg capsule two or three times daily (for those with mild and moderate-to-severe baseline abdominal pain, respectively), for an average of six days, ie, three days before until the end of the first three days of the menstrual period. Throughout all four study cycles, daily self-assessment of symptoms related to premenstrual syndrome was made by each subject using a visual analog scale (VAS). Data were descriptively analyzed and profiled in curves of VAS score versus time point evaluation starting from day 5 before menstruation to day 5 of menstruation.RESULTSTwenty-three subjects of mean age 27.35 ± 5.73 years were evaluable for the intention to treat analysis. Most subjects experienced the primary efficacy variable (abdominal pain), peaking on days 1-2 of the menstrual phase, with a mean VAS score of 36.8 ± 24.3 mm and 30.0 ± 29.6 mm, respectively, during control cycles. DLBS1442 markedly reduced VAS scores by 13.76 ± 28.27 mm (37.46%) and 13.28 ± 29.06 mm (44.28%), respectively. Other symptoms of premenstrual syndrome were also markedly alleviated by DLBS1442. Some mild adverse events were observed and resolved by the end of the study.CONCLUSIONThis preliminary study indicates the effectiveness of DLBS1442 in alleviating primary dysmenorrhea and abdominal pain, as well as other symptoms related to premenstrual syndrome. DLBS1442 was safe and well tolerated in women with premenstrual syndrome and/or dysmenorrhea.

100 项与 DLBS-1442 相关的药物交易

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适应症	国家/地区	公司	日期
痛经	印度	PT Dexa Medica	2015-01-01

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适应症	最高研发状态	国家/地区	公司	日期
子宫内膜异位症	临床1期	印尼	PT Dexa Medica	2015-10-01
中度疼痛	临床1期	印尼	PT Dexa Medica	2015-10-01
重度疼痛	临床1期	印尼	PT Dexa Medica	2015-10-01