Ignite Creation Date:
2024-05-06 @ 1:52 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01913418
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2013-07-28
Brief Title:
Clinical Efficacy and Serum Proteomic Profiling of Suan-Zao-Ren Tang for Sleep Disturbance During Methadone Maintenance
Sponsor:
China Medical University Taiwan
Organization:
China Medical University Taiwan
Study Overview
Official Title:
Clinical Efficacy and Serum Proteomic Profiling of Traditional Chinese Medicine Suan-Zao-Ren Tang for Sleep Disturbance During Methadone Maintenance Study Protocol for a Randomized Double-blind Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of Suan-Zao-Ren Tang in improving sleep quality anxiety depression and heroin craving among methadone-maintained persons with sleep complaints
Detailed Description:
Background
Heroin dependence is one of the major health issues worldwide Methadone Maintenance Therapy MMT is an effective treatment for opioid dependence but more than three quarters of persons receiving MMT report sleep complaints Traditional Chinese Medicine TCM is one of the most common complementary therapies offered to insomnia patients in Taiwan Investigators designed a randomized double-blind placebo-controlled clinical trial to evaluate the efficacy of TCM in methadone-maintained persons with sleep disturbance
Methodsdesign
In this study inclusion criteria are persons receiving MMT for at least one month more than 20 years old complain insomnia with a Pittsburgh Sleep Quality Index PSQI of six or higher Exclusion criteria include being pregnancy had serious physical or mental illness current use last 30 days of TCM had received any antidepressant or neuroleptic medication and inability to read and fill out the forms for the study The patients were separated into an intervention group Suan-Zao-Ren Tang SZRT and a placebo group for four weeks using a randomized double-blind procedure Outcome measures will be assessed at baseline 4 weeks and 8 weeks after receiving medication PSQI was used to assess sleep quality over the past 30 days anxiety and depression levels measured by the Beck Anxiety Inventory BAI and Beck Depression Inventory II BDI-II were also conducted heroin craving degree was evaluated by the change of the visual analog scale VAS Serum proteins will be detected using a proteomics method based on two-dimensional gel electrophoresis and the specificity of proteins will confirmed by western blotting T-test and chi-square tests are used for statistical analysis
Discussion
SZRT is a combination of Semen Zizyphi Spinosae Suanzaoren Sclerotium Poriae Cocos Fuling Radix Ligustici Chuanxiong Chuanxiong Rhizoma Anemarrhena Zhimu and Radix Glycyrrhizae Gancao It was the most commonly prescribed Chinese herbal formula used for the treatment of insomnia In the classical literature and previous studies SZRT was said to calm the nerves and nourish the blood to eventually bring on a tranquillizing sensation and improved the quality of sleep without generating significant side effects In order to evaluate the efficacy of SZRT for sleep disturbance during methadone maintenance investigators designed a randomized double-blind placebo-controlled trial and perform the proteomic-system biology analysis to find the biomarker associated with sleep condition
Heroin dependence is one of the major health issues worldwide Methadone Maintenance Therapy MMT is an effective treatment for opioid dependence but more than three quarters of persons receiving MMT report sleep complaints Traditional Chinese Medicine TCM is one of the most common complementary therapies offered to insomnia patients in Taiwan Investigators designed a randomized double-blind placebo-controlled clinical trial to evaluate the efficacy of TCM in methadone-maintained persons with sleep disturbance
Methodsdesign
In this study inclusion criteria are persons receiving MMT for at least one month more than 20 years old complain insomnia with a Pittsburgh Sleep Quality Index PSQI of six or higher Exclusion criteria include being pregnancy had serious physical or mental illness current use last 30 days of TCM had received any antidepressant or neuroleptic medication and inability to read and fill out the forms for the study The patients were separated into an intervention group Suan-Zao-Ren Tang SZRT and a placebo group for four weeks using a randomized double-blind procedure Outcome measures will be assessed at baseline 4 weeks and 8 weeks after receiving medication PSQI was used to assess sleep quality over the past 30 days anxiety and depression levels measured by the Beck Anxiety Inventory BAI and Beck Depression Inventory II BDI-II were also conducted heroin craving degree was evaluated by the change of the visual analog scale VAS Serum proteins will be detected using a proteomics method based on two-dimensional gel electrophoresis and the specificity of proteins will confirmed by western blotting T-test and chi-square tests are used for statistical analysis
Discussion
SZRT is a combination of Semen Zizyphi Spinosae Suanzaoren Sclerotium Poriae Cocos Fuling Radix Ligustici Chuanxiong Chuanxiong Rhizoma Anemarrhena Zhimu and Radix Glycyrrhizae Gancao It was the most commonly prescribed Chinese herbal formula used for the treatment of insomnia In the classical literature and previous studies SZRT was said to calm the nerves and nourish the blood to eventually bring on a tranquillizing sensation and improved the quality of sleep without generating significant side effects In order to evaluate the efficacy of SZRT for sleep disturbance during methadone maintenance investigators designed a randomized double-blind placebo-controlled trial and perform the proteomic-system biology analysis to find the biomarker associated with sleep condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None