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Evaluating the effect of tropical sildenafil gel on incidence and severity of Raynaud’s Phenomenon Attacks in patients with systemic sclerosis: A double blinded randomized clinical trial

Evaluating the effect of tropical sildenafil gel on incidence and severity of Raynaud’s Phenomenon Attacks in patients with systemic sclerosis: A double blinded randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240203060886N1
Enrollment
70
Registered
2024-02-22
Start date
2024-03-05
Completion date
Unknown
Last updated
2024-03-06

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

Conditions

systemic sclerosis. Systemic sclerosis [scleroderma]

Interventions

Intervention 1: Intervention group: Taking Sildenafil 1% gel 15 grams (under the brand name Erecgel produced by Pishgam Daru Novin Pharmaceutical Company) every 8 hours. Intervention 2: Control group:

Sponsors

Shahre-kord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age over 18 and under 75 years Patients with systemic sclerosis diagnosed by ACR criteria or LeRoy ? Medsger Willingness to participate in the clinical trial Absence of MI, stroke or cardiac arrhythmia in recent 6 month Skin involvement limited to fingers, hands, face, forearms and feet

Exclusion criteria

Exclusion criteria: History of CKD (Creatinine clearance under ?? ml/minute) or cirrhosis (Child-Pugh class C) Overlap syndrome Hypersnsitivity to topical sildenafil

Design outcomes

Primary

MeasureTime frame
Severity of pain. Timepoint: Measurement of pain severity before the intervention and 2 and 6 weeks after the intervention. Method of measurement: Visual Analogue Scale (VAS) Questionnaire.;Quality of life. Timepoint: Measuring different aspects of quality of life before the intervention and 2 and 6 weeks after the intervention. Method of measurement: The World Health Organization Quality of Life Brief Version (WHOQOL-BREF).;Capiloroscopy of the nail bed of patients. Timepoint: before the intervention and 2 and 6 weeks after the intervention. Method of measurement: nailfold capiloroscope.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Rostamian

Shahre-kord University of Medical Sciences

alireza_rostamian@yahoo.com+98 38 3222 5055

Outcome results

None listed

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