Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451328
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-05-28
Brief Title:
Lignosus Rhinoceros TM02 as a Complementary Therapy for Uncontrolled Asthma
Sponsor:
University of Malaya
Organization:
University of Malaya
Study Overview
Official Title:
Lignosus Rhinoceros TM02 as a Complementary Therapy for Uncontrolled Asthma A Prospective Open-label Single-arm Phase II Study
Status:
COMPLETED
Status Verified Date:
2024-06
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 goal of this clinical trial is to learn if TM02 works to treat partially controlled or uncontrolled asthma in adults It will also learn about the efficacy and safety of TM02
The main questions it aims to answer are
Does TM02 causes bronchodilation to what extent improves asthma control and reduces airway inflammation and blood eosinophils and serum immunoglobulin E levels
Participants will
Take TM02 every day for 90 days Visit the clinic once every 30 days for checkups tests and to fill up questionnaires
Keep a diary of their symptoms and the number of times they use a rescue inhaler
The main questions it aims to answer are
Does TM02 causes bronchodilation to what extent improves asthma control and reduces airway inflammation and blood eosinophils and serum immunoglobulin E levels
Participants will
Take TM02 every day for 90 days Visit the clinic once every 30 days for checkups tests and to fill up questionnaires
Keep a diary of their symptoms and the number of times they use a rescue inhaler
Detailed Description:
This 90-day prospective phase II open label single-arm study was conducted from March 2022 to February 2023 Subjects with partially controlled or uncontrolled asthma assessed according to the Global Initiative for Asthma GINA guidelines were enrolled from the outpatient asthma clinic at the Universiti Malaya Medical Centre Kuala Lumpur Malaysia The effects of TM02 on bronchodilation was determined via trough forced expiratory volume in 1 second FEV1 assessment Improvement of asthma control was assessed using the Asthma Control Questionnaire-7 ACQ-7 Serial measurements of fractional exhaled nitric oxide FeNO levels at baseline 30 60 and 90 days were performed to assess the effectiveness of TM02 in reducing FeNO a marker of Type 2 airway inflammation Blood eosinophil count and serum immunoglobulin E IgE level were also measured
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?:
None
Is an FDA AA801 Violation?:
None