Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: End-Stage Renal Disease; Pruritus

Treatments: Drug: Wheat; Drug: Fumaria

Study type: Interventional

Funder types: Other

Identifiers

NCT02671162

IRCT2015080110410N2

Details and patient eligibility

About

The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.

Full description

Uremic Pruritus is still a common complication in end-stage renal disease patients. The pathogenesis of Uremic Pruritus is unknown, therefore treatments are ineffective. According to several studies Uremic Pruritus is not an isolated skin disease. It seems to be a systemic inflammatory disease with a deranged balance of T helper cell differentiation. In this study investigators considered to evaluate effect of Fumaria Parviflora L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Fumaria Parviflora L. may minimize uremic pruritus by decreasing serum Interferon gamma (IFN-γ) and high-sensitive C reactive protein (hs-CRP).

Enrollment: 63 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemodialysis patients
• Suffering from pruritus for at least 6 weeks
• Have not responded to other drugs
• visual analogue scale (VAS) equal or more than 4

Exclusion criteria

• Liver disease
• Respiratory disease
• Dermatological disease
• Hemoglobin less than 10
• Cholestasis
• Malignancies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

63 participants in 2 patient groups, including a placebo group

Wheat

Placebo Comparator group

Description:

Placebo capsule/ 2 capsule 3 times per day

Treatment:

Drug: Wheat

Fumaria

Active Comparator group

Description:

Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day.

Treatment:

Drug: Fumaria