Therapeutic Effects of Jing Si Herbal Tea for COPD
ConditionAirway Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About this trial
Chronic obstructive pulmonary disease (COPD), a leading cause of global mortality, significantly impairs health-related quality of life (HRQL). COPD is characterized by airway inflammation and lung tissue damage. Jing Si herbal tea (JSHT) is known to have anti-inflammatory effects but has not been explored for treating COPD. This study investigated the potential of JSHT as an adjuvant therapy for COPD. This randomized controlled study focused on patients with COPD in the exacerbation and stable phases. The control group received the standard treatment, and the JSHT group received the standard treatment plus JSHT. Both groups underwent HRQL assessments, blood tests, and cellular studies involving five different groups to assess the effect of JSHT on damage-associated molecular patterns (DAMPs) and inflammatory markers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
COPD patients willing to enter this study
Disqualifiers
not COPD patients, no willing to enter this study
Trial design
Design model
Parallel
Treatments tested in this trial
Jing Si herbal tea (JSHT)
Combination productJSHT has been approved by the Ministry of Health and Welfare of Taiwan (registration number MOHW-PM-060635).
Placebo
Other interventionPlacebo of JSHT
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Placebo group (1)Placebo comparator 1 intervention
Group B: Placebo group (2)Placebo comparator 1 intervention
Group C: JSHT group of stable COPDExperimental treatment 1 intervention
Group D: JSHT group of COPDAEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
COPD Assessment Test (CAT)
The Taiwan Society of Pulmonary and Critical Care Medicine offers the Chinese version of the COPD Assessment Test (CAT) on the website (http://tspccm.org.tw). This test consists of eight items designed to evaluate COPD symptoms. These symptoms include cough, phlegm production, chest tightness, breathlessness, limitations in daily activities, confidence in leaving the house, sleep disturbances, and energy levels. Each symptom is rated on a scale from 0 to 5, culminating in a total CAT score ranging from 0 to 40. A higher score reflects more severe COPD symptoms. A score of 10 or higher is indicative of a significant symptom burden.
Time frame
Assess at baseline and three months of treatment2
Modified Medical Research Council (mMRC)
The Modified Medical Research Council (mMRC) scale was used to evaluate dyspnea. This scale, comprising a 5-point grading system ranging from 0 to 4, measures dyspnea severity. A score of 0 indicates dyspnea only during intense exercise, while a sore of 4 represents breathlessness at rest.
Time frame
Assess at baseline and three months of treatment3
Brief Symptom Rating Scale (BSRS-5)
The 5-item Brief Symptom Rating Scale (BSRS-5) was used to assess psychological distress. It consists of five items: feeling tense, being easily angered, feeling depressed, feeling inferior to others, difficulty with sleep, and suicidal thoughts. The scale is a 5-point scale ranging from 0 (not at all) to 4 (extremely), with higher scores indicating more severe symptoms.
Time frame
Assess at baseline and three months of treatmentSponsors and contacts
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Source ClinicalTrials.gov