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The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04650750
Collaborator
(none)
60
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Jan 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin

Xiao-Feng-San 2g+ Shian Fang Hwa Ming Yiin 2g; twice a day for two months

Drug: Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin
"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.
Placebo Comparator: Placebo

Similar placebo 4g twice a day for two months

Drug: Placebo
Similar placebo 4g twice a day for two months

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale(VAS) [on starting day (day 0)]

    Measuring itch intensity

  2. Visual Analogue Scale(VAS) [on day 28]

    Measuring itch intensity

  3. Visual Analogue Scale(VAS) [on day 56]

    Measuring itch intensity

  4. Visual Analogue Scale(VAS) [on day 84]

    Measuring itch intensity

  5. 5-D itch scale [on starting day (day 0)]

    (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness

  6. 5-D itch scale [on day 28]

    (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness

  7. 5-D itch scale [on day 56]

    (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness

  8. 5-D itch scale [on day 84]

    (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. 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

  2. An intermittent itch over a period of 6 months or more, with a clinical appearance, but with a lower frequency than in (1)

  3. People with clear consciousness, without cognitive impairment

  4. Those who can cooperate to fill in relevant questionnaires

  5. Willing to sign consent forms

  6. Blood test indicators: (1) Intact parathyroid hormone (iPTH) <600 pg/ml (2) Kt/V >1.2 (3) Serum phosphate <6 mg/dl

  7. 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:

  1. Be younger than 20 years old.

  2. People suffering from diagnosed skin diseases (scabies, drug allergy, atopic dermatitis), severe infections, liver failure, blood diseases or biliary diseases.

  3. Patients with abnormal liver and kidney function.

  4. People suffering from cognitive dysfunction caused by neurological diseases or mental diseases.

  5. People with severe visual impairment, hearing impairment, and physical impairment that affect the scale test.

  6. Those who are undergoing other trials.

  7. Those who are pregnant or breastfeeding.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04650750
Other Study ID Numbers:
  • CMRPG1J0131
First Posted:
Dec 3, 2020
Last Update Posted:
Dec 3, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang Gung Memorial Hospital
Uremic pruritus; Hemodialysis; Chinese medicine; Xiao-Feng-San; Shian Fang Hwa Ming Yiin
Additional relevant MeSH terms:
Pruritus

Study Results

No Results Posted as of Dec 3, 2020