Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the epidemiological status of traditional Chinese Medicine (TCM) constitution in patients with dialytic hypotension, and design a clinical study based on a Zheng-based herbal formulation to evaluate the clinical efficacy and safety of TCM
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHM intervention group | Experimental |
| |
| Control group | Other | Participants who do not receive the active CHM treatment during the study's initial phase (8 weeks) but are offered it after the trial ends. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHM intervention group | Drug | Jia Wei Sheng Yu Si Ni Tang (JWSYSNT) powder, 4.5 gm per dose, taken orally 2 times a day, for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total intradialytic hypotension (IDH) epidose | IDH episode was record on every dialysis session, account for 24 dialysis sessions. ( IDH was defined as a nadir SBP of < 90 mmHg or requirement for clinical intervention). | week 1 to 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Intradialytic blood pressure (BP) measurement | Pre-, nadir-, and post-dialysis systolic and diastolic blood pressure in mmHg at each session. | week 1 to 8 |
| Pharmacotherapy | Frequent and dose in mg of vasopressor agents at each session |
| Measure | Description | Time Frame |
|---|---|---|
| Constitution in Chinese Medicine Questionnaire | All participants were asked to complete a basic information questionnaire before CHM treatment and an assessment of their TCM constitution. The CCMQ consisted of 60 items (clinical observations, indicators of constitutions, Table 2) categorized into 9 subscales, each measuring one of the 9 different body constitutions, namely, Yang-deficient (7 items), Yin-deficient (8 items), Qi-deficient (8 items), Phlegm-dampness (8 items), Damp-heat (6 items), Stagnant Blood (7 items), Inherited Special (7 items), Stagnant Qi (7 items), and Balanced (8 items). The items were on a 5-point Likert scale, with high scores indicating a higher likelihood of having the given constitution. Usually, a threshold of 30 or higher points on a subscale was used to classify a person as having that body constitution. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yen Tsai, PhD | Contact | 886-975-056534 | missuriae@yahoo.com.tw |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital in Kaohsiung branch | Kaohsiung City | 83301 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No CHM treatment | Other | The waitlist control group received no JWSYSNT treatments and received no other intervention for 8 weeks after randomization. |
|
| week 1 to 8 |
| Kidney Disease and Quality of Life-36 (KDQOL-36) | The Taiwanese version of the. KDQOL-36 questionnaire is reliable and valid for evaluating the quality of life in dialysis patients. It includes 12 items that provide a generic chronic disease core (i.e., the SF-12, a shorter version of the SF-36), as well as 24 additional items (i.e., kidney-disease-targeted items). The 24 additional items focus on particular health-related concerns of individuals with kidney disease (i.e., symptom/problem list, 12 items; effects of kidney disease, 8 items; and burden of disease, 4 items).KDQOL-36 subscale scores ranged from 0 to 100, and lower scores indicated worse self-reported quality of life. | week 1 and 8 |
| week 0 |