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Studying the effect of Sankol on reducing kidney stone size and helping its passage

evaluation of the effects of Sankol (soft gel and drop) on the size of kidney stones and facilitation of stone expulsion in adult patients with nephrolithiasis: A randomized controlled clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160713028901N7
Enrollment
126
Registered
2025-05-06
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Nephrolithiasis (kidney Stones). Calculus of kidney

Interventions

Intervention 1: Intervention group: Sankol oral drop (60 drops, three times daily). Each ml of Sankol contains extracts of Foeniculum vulgare (250 mg), Laurus nobilis (125 mg), Tribulus terrestris (12

Sponsors

Goldaru Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients ( over 18 years old) Patients with normal renal function, defined as eGFR > 60 mL/min/1.73 m² Definitive diagnosis of nephrolithiasis confirmed by ultrasonography Patients diagnosed with urolithiasis who are actively passing a stone and presenting with renal colic Upon obtaining informed consent and agreement to participate

Exclusion criteria

Exclusion criteria: Patients with cystine or struvite stones will be excluded from the study Failure to adhere to treatment protocols and incorrect use of medications Development of serious adverse effects or allergic reactions to the study medication Lack of follow-up and inability to contact the patient for future evaluations Patient’s decision to withdraw from the study Presence of chronic diseases including active malignancy, chronic liver disease, or heart failure Pregnancy

Design outcomes

Primary

MeasureTime frame
Reduction in kidney or ureteral stone size. Timepoint: At baseline and at the end of treatment (after 3 months). Method of measurement: Measured using ultrasound imaging and recorded in millimeters.;Change in the number of kidney or ureteral stones. Timepoint: At baseline and at the end of treatment (3 months or upon stone expulsion). Method of measurement: Assessed by ultrasound imaging and recorded as count.;Duration of stone expulsion. Timepoint: From start of treatment until complete stone expulsion. Method of measurement: Self-reported by patient and confirmed by ultrasound.

Secondary

MeasureTime frame
Daily water intake. Timepoint: Recorded weekly throughout the treatment period. Method of measurement: Self-reported by the patient using a daily intake log.;Presence of a family history of kidney stones. Timepoint: Collected at baseline. Method of measurement: Patient interview and medical history questionnaire.;Frequency of previous kidney stone episodes. Timepoint: Collected at baseline. Method of measurement: Patient history and medical record review.;History of surgical interventions for kidney stones. Timepoint: Collected at baseline. Method of measurement: Medical history interview and documentation.;Current medications for kidney or urinary tract stones. Timepoint: Assessed at baseline and monitored during follow-up. Method of measurement: Medication history interview and review of prescriptions.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShirin Sadat Badri

Esfahan University of Medical Sciences

badri@pharm.mui.ac.ir+98 31 3792 7069

Outcome results

None listed

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