Back to resultsThe Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
Primary Purpose
Uremic Pruritus
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uremic Pruritus focused on measuring Uremic pruritus; Hemodialysis; Chinese medicine; Xiao-Feng-San; Shian Fang Hwa Ming Yiin
Eligibility Criteria
Inclusion Criteria:
- At least 3 episodes of itch during 2 weeks or less, the itch occurring several times a day, lasting for more than 5 min and being bothersome
- An intermittent itch over a period of 6 months or more, with a clinical appearance, but with a lower frequency than in (1)
- People with clear consciousness, without cognitive impairment
- Those who can cooperate to fill in relevant questionnaires
- Willing to sign consent forms
- Blood test indicators: (1) Intact parathyroid hormone (iPTH) <600 pg/ml (2) Kt/V >1.2 (3) Serum phosphate <6 mg/dl
- Refractory uremic pruritus; The patient failed to respond to following treatments (1) avoiding food containing high amounts of phosphate (2) haemodialysis with a dialysate containing 3.0 or 2.5 mEq/l of calcium (3) changing the dialyser or increasing blood flow
Exclusion Criteria:
- Be younger than 20 years old.
- People suffering from diagnosed skin diseases (scabies, drug allergy, atopic dermatitis), severe infections, liver failure, blood diseases or biliary diseases.
- Patients with abnormal liver and kidney function.
- People suffering from cognitive dysfunction caused by neurological diseases or mental diseases.
- People with severe visual impairment, hearing impairment, and physical impairment that affect the scale test.
- Those who are undergoing other trials.
- Those who are pregnant or breastfeeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin
Placebo
Arm Description
Xiao-Feng-San 2g+ Shian Fang Hwa Ming Yiin 2g; twice a day for two months
Similar placebo 4g twice a day for two months
Outcomes
Primary Outcome Measures
Visual Analogue Scale(VAS)
Measuring itch intensity
Visual Analogue Scale(VAS)
Measuring itch intensity
Visual Analogue Scale(VAS)
Measuring itch intensity
Visual Analogue Scale(VAS)
Measuring itch intensity
5-D itch scale
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
5-D itch scale
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
5-D itch scale
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
5-D itch scale
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Secondary Outcome Measures
Full Information
NCT ID
NCT04650750
First Posted
October 28, 2020
Last Updated
November 25, 2020
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04650750
Brief Title
The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
Official Title
The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine.
Detailed Description
The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine. "Xiao-Feng-San" is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of "Xiao-Feng-San" has immunomodulatory activity. "Shian Fang Hwa Ming Yiin" is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of "Shian Fang Hwa Ming Yiin" has anti-inflammation and anti-microbial effect.
The purpose of this study is to evaluate the treatment effect of Xiao-Feng-San and Shian Fang Hwa Ming Yiin on uremic pruritus among hemodialysis patients in this randomized, double-blind, placebo-controlled study design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
Uremic pruritus; Hemodialysis; Chinese medicine; Xiao-Feng-San; Shian Fang Hwa Ming Yiin
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin
Arm Type
Experimental
Arm Description
Xiao-Feng-San 2g+ Shian Fang Hwa Ming Yiin 2g; twice a day for two months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Similar placebo 4g twice a day for two months
Intervention Type
Drug
Intervention Name(s)
Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin
Intervention Description
"Xiao-Feng-San" is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of "Xiao-Feng-San" has immunomodulatory activity. "Shian Fang Hwa Ming Yiin" is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of "Shian Fang Hwa Ming Yiin" has anti-inflammation and anti-microbial effect.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Similar placebo 4g twice a day for two months
Primary Outcome Measure Information:
Title
Visual Analogue Scale(VAS)
Description
Measuring itch intensity
Time Frame
on starting day (day 0)
Title
Visual Analogue Scale(VAS)
Description
Measuring itch intensity
Time Frame
on day 28
Title
Visual Analogue Scale(VAS)
Description
Measuring itch intensity
Time Frame
on day 56
Title
Visual Analogue Scale(VAS)
Description
Measuring itch intensity
Time Frame
on day 84
Title
5-D itch scale
Description
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Time Frame
on starting day (day 0)
Title
5-D itch scale
Description
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Time Frame
on day 28
Title
5-D itch scale
Description
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Time Frame
on day 56
Title
5-D itch scale
Description
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Time Frame
on day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 3 episodes of itch during 2 weeks or less, the itch occurring several times a day, lasting for more than 5 min and being bothersome
An intermittent itch over a period of 6 months or more, with a clinical appearance, but with a lower frequency than in (1)
People with clear consciousness, without cognitive impairment
Those who can cooperate to fill in relevant questionnaires
Willing to sign consent forms
Blood test indicators: (1) Intact parathyroid hormone (iPTH) <600 pg/ml (2) Kt/V >1.2 (3) Serum phosphate <6 mg/dl
Refractory uremic pruritus; The patient failed to respond to following treatments (1) avoiding food containing high amounts of phosphate (2) haemodialysis with a dialysate containing 3.0 or 2.5 mEq/l of calcium (3) changing the dialyser or increasing blood flow
Exclusion Criteria:
Be younger than 20 years old.
People suffering from diagnosed skin diseases (scabies, drug allergy, atopic dermatitis), severe infections, liver failure, blood diseases or biliary diseases.
Patients with abnormal liver and kidney function.
People suffering from cognitive dysfunction caused by neurological diseases or mental diseases.
People with severe visual impairment, hearing impairment, and physical impairment that affect the scale test.
Those who are undergoing other trials.
Those who are pregnant or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiun-Liang Chen, Ph.D
Phone
+88633196200
Ext
2611
Email
a12015@adm.cgmh.org.tw
12. IPD Sharing Statement
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The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
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