NCT04650750

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2020

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 3, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 28, 2020

Last Update Submit

November 25, 2020

Conditions

Uremic Pruritus

Keywords

Uremic pruritus; Hemodialysis; Chinese medicine; Xiao-Feng-San; Shian Fang Hwa Ming Yiin

Outcome Measures

Primary Outcomes (8)

  • Visual Analogue Scale(VAS)

    Measuring itch intensity

    on starting day (day 0)

  • Visual Analogue Scale(VAS)

    Measuring itch intensity

    on day 28

  • Visual Analogue Scale(VAS)

    Measuring itch intensity

    on day 56

  • Visual Analogue Scale(VAS)

    Measuring itch intensity

    on day 84

  • 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

    on starting day (day 0)

  • 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

    on day 28

  • 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

    on day 56

  • 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

    on day 84

Study Arms (2)

Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Similar placebo 4g twice a day for two months

Drug: Placebo

Interventions

Xiao-Feng-San+Shian-Fang-Hwa-Ming-YiinDRUG

"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.

Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin
PlaceboDRUG

Similar placebo 4g twice a day for two months

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Mathur VS, Lindberg J, Germain M, Block G, Tumlin J, Smith M, Grewal M, McGuire D; ITCH National Registry Investigators. A longitudinal study of uremic pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Aug;5(8):1410-9. doi: 10.2215/CJN.00100110. Epub 2010 Jun 17.

    PMID: 20558560BACKGROUND

  • Rayner HC, Larkina M, Wang M, Graham-Brown M, van der Veer SN, Ecder T, Hasegawa T, Kleophas W, Bieber BA, Tentori F, Robinson BM, Pisoni RL. International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2000-2007. doi: 10.2215/CJN.03280317. Epub 2017 Sep 18.

    PMID: 28923831BACKGROUND

  • Kuypers DR. Skin problems in chronic kidney disease. Nat Clin Pract Nephrol. 2009 Mar;5(3):157-70. doi: 10.1038/ncpneph1040. Epub 2009 Feb 3.

    PMID: 19190625BACKGROUND

  • Szepietowski JC, Morita A, Tsuji T. Ultraviolet B induces mast cell apoptosis: a hypothetical mechanism of ultraviolet B treatment for uraemic pruritus. Med Hypotheses. 2002 Feb;58(2):167-70. doi: 10.1054/mehy.2001.1505.

    PMID: 11812197BACKGROUND

  • Kim KH, Lee MS, Choi SM. Acupuncture for treating uremic pruritus in patients with end-stage renal disease: a systematic review. J Pain Symptom Manage. 2010 Jul;40(1):117-25. doi: 10.1016/j.jpainsymman.2009.11.325.

    PMID: 21796811BACKGROUND

  • Okada K, Matsumoto K. Effect of skin care with an emollient containing a high water content on mild uremic pruritus. Ther Apher Dial. 2004 Oct;8(5):419-22. doi: 10.1111/j.1526-0968.2004.00175.x.

    PMID: 15663539BACKGROUND

  • Young TA, Patel TS, Camacho F, Clark A, Freedman BI, Kaur M, Fountain J, Williams LL, Yosipovitch G, Fleischer AB Jr. A pramoxine-based anti-itch lotion is more effective than a control lotion for the treatment of uremic pruritus in adult hemodialysis patients. J Dermatolog Treat. 2009;20(2):76-81. doi: 10.1080/09546630802441218.

    PMID: 18821119BACKGROUND

  • Tarng DC, Cho YL, Liu HN, Huang TP. Hemodialysis-related pruritus: a double-blind, placebo-controlled, crossover study of capsaicin 0.025% cream. Nephron. 1996;72(4):617-22. doi: 10.1159/000188949.

    PMID: 8730431BACKGROUND

  • Russo GE, Spaziani M, Guidotti C, Scarpellini MG, Leri O, Bonini S, Crisciotti C, Carmenini G. [Pruritus in chronic uremic patients in periodic hemodialysis. Treatment with terfenadine (an antagonist of histamine H1 receptors)]. Minerva Urol Nefrol. 1986 Oct-Dec;38(4):443-7. No abstract available. Italian.

    PMID: 2884733BACKGROUND

  • Rayner H, Baharani J, Smith S, Suresh V, Dasgupta I. Uraemic pruritus: relief of itching by gabapentin and pregabalin. Nephron Clin Pract. 2012;122(3-4):75-9. doi: 10.1159/000349943. Epub 2013 Mar 28.

    PMID: 23548570BACKGROUND

  • Simonsen E, Komenda P, Lerner B, Askin N, Bohm C, Shaw J, Tangri N, Rigatto C. Treatment of Uremic Pruritus: A Systematic Review. Am J Kidney Dis. 2017 Nov;70(5):638-655. doi: 10.1053/j.ajkd.2017.05.018. Epub 2017 Jul 15.

    PMID: 28720208BACKGROUND

  • Cheng HM, Chiang LC, Jan YM, Chen GW, Li TC. The efficacy and safety of a Chinese herbal product (Xiao-Feng-San) for the treatment of refractory atopic dermatitis: a randomized, double-blind, placebo-controlled trial. Int Arch Allergy Immunol. 2011;155(2):141-8. doi: 10.1159/000318861. Epub 2010 Dec 22.

    PMID: 21196758BACKGROUND

  • Chen HY, Lin YH, Chen YC. Identifying Chinese herbal medicine network for treating acne: Implications from a nationwide database. J Ethnopharmacol. 2016 Feb 17;179:1-8. doi: 10.1016/j.jep.2015.12.032. Epub 2015 Dec 22.

    PMID: 26721214BACKGROUND

Central Study Contacts

Jiun-Liang Chen, Ph.D

CONTACT

+88633196200a12015@adm.cgmh.org.tw

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

December 3, 2020

Study Start

December 1, 2020

Primary Completion

January 31, 2021

Study Completion

December 31, 2021

Last Updated

December 3, 2020

Record last verified: 2020-10