Clinical Trial to Evaluate the Effect of Blood Stasis Leaflet in Patients with Metabolic Disorder
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009289
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
In a study involving 40 patients (mean age: 62.3±7.8 years), symptoms persisted for an average of 16.75±9.3 hours daily, with a severity rating of 2.53. BS leaflet group exhibited significantly higher satisfaction scores across all measured aspects, including satisfaction with DKMs' explanations, understanding, reliability of TKM, treatment duration, overall satisfaction, perceived improvement in explanations compared to previous experiences, and the perceived need for managing BS treatment (all p<.0001). Despite non-significant period or sequence effects, the BS leaflet group consistently demonstrated notably higher scores across all questionnaire aspects, indicating statistically significant treatment effects in the linear-mixed model (all p<.0001).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion criteria for study participants were adults aged 50 years or older with metabolic disorders such as stroke and cardiovascular diseases, those who voluntarily signed an informed consent form (however, those unable to voluntarily provide consent were represented by a legally authorized representative) and reliably cooperated throughout the study while adhering to imposed
limitations.
Exclusion criteria were those who have mental disorders, are unconscious critically ill patients with communication difficulties, pregnant women, and possess other conditions that could affect the subsequent evaluation.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient satisfaction survey;Doctor satisfaction survey;Doctor ease of treatment survey
- Secondary Outcome Measures
Name Time Method Present Illness: Onset, duration and severity of symptoms, Chief complaint, ;Social history: Alcohol comsumptions status, Smoking status, Employment status;Traditional Korean Medicine treatment details