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The efficacy of Fumaria parviflora L. versus gabapentin on pruritus of patients undergoing hemodialysis

The efficacy of Fumaria parviflora L. versus gabapentin on uremic pruritus of patients undergoing hemodialysis: A randomized non-inferiority double-blinded active-controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20121031011341N11
Enrollment
70
Registered
2023-02-25
Start date
2023-03-06
Completion date
Unknown
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremic prururitus in dialysis patient. Pruritus

Interventions

Intervention 1: first intervention group: the patients in this group are given 2 grams of Fumaria parviflora L. in the form of 6 capsules of 330 mg as two capsules three times a day and one placebo ca

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The hemodialysis patient who has uncontrollable pruritus and now at least 1 week doesn't use any antipruritus medication who had pruritus for at least 6 weeks patient must have normal range phosphor and potassium in the past month Parathyroid Hormone (PTH) must be lower than 500 measured visual analogue scale (VAS) score must be four or more

Exclusion criteria

Exclusion criteria: They do not have liver disease, a history of convulsions, or a specific skin disease that causes itching, and they do not have hemolytic blood disease. Patients who complain of itching for the first time are not included in the study If the patient was taking medication that interacted with gabapentin or Fumaria parviflora L., he was not included in the study Those who are allergic to Fumaria parviflora L. or Gabapentin are not included in the study

Design outcomes

Primary

MeasureTime frame
Itching score in the 5-D pruritus questionnaire. Timepoint: Before the start of the intervention (the beginning of the study) and two months later (the end of the study). Method of measurement: 5D itch questionnaire.

Secondary

MeasureTime frame
Quality of life score in DLQI questionnaire. Timepoint: Before the start of the intervention (the beginning of the study) and two months later (the end of the study). Method of measurement: DLQI quality of life questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHosseini Seyed Ali

Shiraz University of Medical Sciences

hoseiniseyyedali70@gmail.com+98 71 3647 4332

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026