Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT01531933
Brief Summary:
This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of DLBS3233.
It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured by the improvement of prandial (particularly the first phase) insulin secretion as well as insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes into type 2 diabetes mellitus.
Detailed Description:
There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 for 12 weeks of therapy.
Subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. All subjects will be advised to follow such a lifestyle modification throughout the study period.
All subjects will be under direct supervision of a medical doctor during the study period.
All clinical and laboratory examinations to evaluate the investigational drug's efficacy, will be performed at baseline, Week 8th and Week 12th (end) of study treatment. Blood glucose level (both FPG and 2h-PG) will be performed at baseline and at interval of 4 weeks over the 12 weeks of study treatment. Safety examinations will be performed at baseline and at the end of study. Occurrence of adverse event will be observed during the study.
Study:
NCT01531933
Study Brief:
Protocol Section:
NCT01531933