Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511011
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Chinese Medicine in Treating Insomnia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Modified Suan ZaoRen Tang-TianWang BuXin Dan in the Treatment of Chronic Insomnia A Randomized Double-blinded Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blinded placebo-controlled clinical trial Eligible participants will randomized into either treatment group CM granules or placebo group placebo granules for 6 weeks followed by a post-treatment visit at week 9 The primary outcome is the change in Pittsburgh Sleep Quality Index PSQI at week 6
Detailed Description:
Insomnia is one of the most general health concerns in the society It is generally defined as a self-reported sleep disorder problem of the patient characterized by difficulty in falling asleep or difficulty maintaining sleep According to American Insomnia Survey 426 of the respondents reported of having at least one of the insomnia symptoms
Chinese medicine can be an alternative to the treatment of insomnia Suan Zao Ren Tang and Tian Wang Bu Xin Dan are two of the most common Chinese herbal formulae to treat insomnia for which Suan Zao Ren Tang has the functions to nourish blood and calm the mind clear heat and alleviate vexation and Tian Wang Bu Xin Dan has the function to nourish the heart and calm the mind and nourish Yin and clear heat In this study we will modify the formula of Suan ZaoRen Tang with TianWang BuXin Dan and observe the effectiveness and safety of the study drug
Chinese medicine can be an alternative to the treatment of insomnia Suan Zao Ren Tang and Tian Wang Bu Xin Dan are two of the most common Chinese herbal formulae to treat insomnia for which Suan Zao Ren Tang has the functions to nourish blood and calm the mind clear heat and alleviate vexation and Tian Wang Bu Xin Dan has the function to nourish the heart and calm the mind and nourish Yin and clear heat In this study we will modify the formula of Suan ZaoRen Tang with TianWang BuXin Dan and observe the effectiveness and safety of the study drug
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