Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579183
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Clinical Trial for Health Products in Emotional Disorders and Insomnia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Health Products Combining Traditional Chinese Medicines Vitamins and Amino Acids for Emotional Disorders and Insomnia a Pilot Double-blinded Randomized Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 pilot double-blinded randomized placebo-controlled trial A total of 60 patients aged 18-65 with emotional disorders will be recruited They will be randomly assigned to receive placebo Extra Strength VitaJoy ESVJ and Extra Strength Vita Calm ESVC 30 each for 12 weeks ESVJ and ESVC are two health products that are formulated by combining Chinese medicines multiple vitamins and amino acids Please refer to the study protocol for the formula of the two products The primary outcome will be assessed using the Beck Anxiety Inventory BAI The secondary outcomes include the Beck Depression Inventory II BDI-II for depression the Pittsburgh Sleep Quality Index PSQI for sleep quality and the World Health Organization Quality of Life-Brief WHOQOL-BREF HK version for the general quality of life A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the 2 groups
Detailed Description:
Emotional disorders are generally referred to as coexisting anxiety and depression as core symptoms often accompanied by physical and sleep problems Emotional disorders and insomnia are highly prevalent in the general population This has become more severe during and after the COVID-19 pandemic and the global prevalence of emotional disorders with insomnia has dramatically risen since the COVID-19 pandemic with 174 for insomnia 256 for anxiety and 231 for depression In Hong Kong 19 suffer from depression and 14 have anxiety However emotional disorders and insomnia are often underdiagnosed and vastly undertreated because the condition of most individuals is mild and they fear drugs side effects which sometimes are a greater risk than the disease itself The development of novel alternative treatment strategies is therefore greatly desired
A vast number of studies have suggested the benefits of Chinese medicines vitamins and amino acid supplementary products in improving anxiety depression and insomnia Extra Strength VitaJoy ESVJ and Extra Strength Vita Calm ESVC are two health products that are formulated by combining Chinese medicines multiple vitamins and amino acids The two products are thought to tranquilize anxiety and nervousness relieve sadness and depression and improve sleeplessness Our preliminary animal studies have suggested that Chinese medicines of ESVJ noticeably reduced depression-like behavior in animal models probably via the modulation of monoamine oxidase MAO without inducing herb-drug interaction or hypertension Chinese medicines of ESVC rapidly induced sleep in animals and reduced anxiety and their efficacy was comparable to that of benzodiazepines A pilot clinical observation revealed that Chinese medicine preparation of ESVC could improve multiple sleep variables recorded by Actiwatch and diary Results of our preliminary studies have encouraged us to further conduct a randomized controlled trial to confirm the efficacy of the two products
A vast number of studies have suggested the benefits of Chinese medicines vitamins and amino acid supplementary products in improving anxiety depression and insomnia Extra Strength VitaJoy ESVJ and Extra Strength Vita Calm ESVC are two health products that are formulated by combining Chinese medicines multiple vitamins and amino acids The two products are thought to tranquilize anxiety and nervousness relieve sadness and depression and improve sleeplessness Our preliminary animal studies have suggested that Chinese medicines of ESVJ noticeably reduced depression-like behavior in animal models probably via the modulation of monoamine oxidase MAO without inducing herb-drug interaction or hypertension Chinese medicines of ESVC rapidly induced sleep in animals and reduced anxiety and their efficacy was comparable to that of benzodiazepines A pilot clinical observation revealed that Chinese medicine preparation of ESVC could improve multiple sleep variables recorded by Actiwatch and diary Results of our preliminary studies have encouraged us to further conduct a randomized controlled trial to confirm the efficacy of the two products
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