Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789186
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2023-02-11
Brief Title:
Clinical Study of Cang Ai Volatile Oil CAVO on Mild to Moderate Depression in Children and Adolescents
Sponsor:
Chen Qian
Organization:
Yunnan University of Chinese Medicine
Study Overview
Official Title:
Clinical Study of Cang Ai Volatile Oil CAVO on Mild to Moderate Depression in Children and Adolescents
Status:
RECRUITING
Status Verified Date:
2023-03
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:
A randomized controlled trial was conducted to observe the improvement of mild to moderate depressive symptoms in children and adolescents with the aromatic herbal compound Cang Ai Volatile Oil CAVO and to evaluate the effectiveness and safety of the clinical application of CAVO
Detailed Description:
The trial was divided into screening period pre-treatment period treatment period first session second session and follow-up period
1 Screening period 14 days before intervention to 2 days before intervention 108 patients with mild to moderate adolescent depression regardless of gender are to be enrolled Patients will sign an informed consent form and will complete the screening period from the 14th pre-intervention day to the 2nd pre-intervention day
2 Pre-treatment 1 day prior to intervention Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will obtain a randomisation number 1 day prior to dosing and will be randomised in a 111 ratio to either the trial group Group A positive drug group Group B or blank control group Group C Subjects undergo an alcohol breath test and urine drug screen on an empty stomach at the test site to determine if they meet the entry criteria Blood tests will be taken on an empty stomach on the day of the trial for testing followed by food and 30 minutes later blood pressure and EEG measurements will be taken and a depression scale will be completed after completion of NIR brain function measurements
3 Treatment period first course weeks 1 to 4 second course weeks 5 to 8
1 Test group Each subject was given a sufficient amount of CAVO aromatherapy patch fluoxetine hydrochloride mimetic at a concentration of 3 The subject was instructed to fix the aromatherapy patch on the near-nasal part of the mouthpiece daily and complete two sniffing inhalations at fixed times 0745-0800 and 1945-2000 daily during the course of the treatment period each time for 15 minutes and to take 1 tablet of fluoxetine mimetic orally once a day times
2 Positive drug group Each subject was given a sufficient amount of CAVO aromatherapy patch fluoxetine hydrochloride tablet 20mgtablet at a concentration of 01 and was instructed to take fluoxetine hydrochloride tablet 20mgtablet orally 10mgdose once a day The aromatherapy patch was applied to the nasal area of the mask once a day
3 Blank control group Subjects were given a sufficient amount of CAVO aromatherapy patch fluoxetine hydrochloride mimetic 20mgtablet at a concentration of 01 and were instructed to fix the aromatherapy patch on the near nasal area of the mouthpiece twice a day during the treatment period at fixed times 0745-0800 and 1945-2000 and to take 1 tablet of fluoxetine mimetic by mouth for 15 minutes each time tablet of fluoxetine mimetic 20mgtablet 10mgdose once a day
Subjects will be required to complete blood pressure measurements EEG measurements and NIR brain function measurements at the end of the first and second sessions respectively and then complete a depression rating scale Blood will also need to be taken on an empty stomach at the end of the treatment period for submission for testing
4 Follow-up period Week 9 to 10 Patients complete a follow-up examination at week 9 to 10 after the first dose The investigator will continue to follow up with you by telephone for 1 week at least 2 times 1 day and 1 week after the end of the trial to see how you are doing You will be asked to answer a call back from your doctor and you will need to cooperate with the investigators questioning
1 Screening period 14 days before intervention to 2 days before intervention 108 patients with mild to moderate adolescent depression regardless of gender are to be enrolled Patients will sign an informed consent form and will complete the screening period from the 14th pre-intervention day to the 2nd pre-intervention day
2 Pre-treatment 1 day prior to intervention Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will obtain a randomisation number 1 day prior to dosing and will be randomised in a 111 ratio to either the trial group Group A positive drug group Group B or blank control group Group C Subjects undergo an alcohol breath test and urine drug screen on an empty stomach at the test site to determine if they meet the entry criteria Blood tests will be taken on an empty stomach on the day of the trial for testing followed by food and 30 minutes later blood pressure and EEG measurements will be taken and a depression scale will be completed after completion of NIR brain function measurements
3 Treatment period first course weeks 1 to 4 second course weeks 5 to 8
1 Test group Each subject was given a sufficient amount of CAVO aromatherapy patch fluoxetine hydrochloride mimetic at a concentration of 3 The subject was instructed to fix the aromatherapy patch on the near-nasal part of the mouthpiece daily and complete two sniffing inhalations at fixed times 0745-0800 and 1945-2000 daily during the course of the treatment period each time for 15 minutes and to take 1 tablet of fluoxetine mimetic orally once a day times
2 Positive drug group Each subject was given a sufficient amount of CAVO aromatherapy patch fluoxetine hydrochloride tablet 20mgtablet at a concentration of 01 and was instructed to take fluoxetine hydrochloride tablet 20mgtablet orally 10mgdose once a day The aromatherapy patch was applied to the nasal area of the mask once a day
3 Blank control group Subjects were given a sufficient amount of CAVO aromatherapy patch fluoxetine hydrochloride mimetic 20mgtablet at a concentration of 01 and were instructed to fix the aromatherapy patch on the near nasal area of the mouthpiece twice a day during the treatment period at fixed times 0745-0800 and 1945-2000 and to take 1 tablet of fluoxetine mimetic by mouth for 15 minutes each time tablet of fluoxetine mimetic 20mgtablet 10mgdose once a day
Subjects will be required to complete blood pressure measurements EEG measurements and NIR brain function measurements at the end of the first and second sessions respectively and then complete a depression rating scale Blood will also need to be taken on an empty stomach at the end of the treatment period for submission for testing
4 Follow-up period Week 9 to 10 Patients complete a follow-up examination at week 9 to 10 after the first dose The investigator will continue to follow up with you by telephone for 1 week at least 2 times 1 day and 1 week after the end of the trial to see how you are doing You will be asked to answer a call back from your doctor and you will need to cooperate with the investigators questioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None