The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus

Uremic Pruritus Clinical Trial

Official title:

The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04650750
• Other study ID #: CMRPG1J0131
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: Chang Gung Memorial Hospital
• Contact: Jiun-Liang Chen, Ph.D
• Phone: +88633196200
• Email: a12015[@]adm.cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

Intervention

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
Similar placebo 4g twice a day for two months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

References & Publications (13)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Italian. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale(VAS)	Measuring itch intensity	on starting day (day 0)
Primary	Visual Analogue Scale(VAS)	Measuring itch intensity	on day 28
Primary	Visual Analogue Scale(VAS)	Measuring itch intensity	on day 56
Primary	Visual Analogue Scale(VAS)	Measuring itch intensity	on day 84
Primary	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)
Primary	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
Primary	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
Primary	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