NCT06451328

Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma

Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma: A Prospective, Open-label, Single-arm, Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Lignosus rhinoceros TM02®	Lignosus rhinoceros TM02®

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2024-06-11
• Last updated: 2024-06-11

Locations

1 site across 1 country: Malaysia