FindTrial
Sign In

Clinical study to evaluate Efficacy and Safety of Clearstone syrup (sugar free)in Asymptomatic renal calculi patients.

A Prospective, Interventional, Randomized, Double-blind, Placebo-controlled, Clinical study to evaluate the Efficacy and Safety of Clearstone syrup (sugar free) in Patients with Asymptomatic Renal calculi. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072127
Enrollment
100
Registered
2024-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: N200- Calculus of kidney

Interventions

Intervention1: Clearstone syrup (sugar free): Dosage form: syrup, route of administration: oral, frequency: 2 tea spoonful (10ml)(TID), treatment duration: 16 weeks, study duration: 17 weeks. Control

Sponsors

SBL Pvt. Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Both male and female patients aged 18-70 years with a diagnosis of renal stone size upto 10mm confirmed by non-contrast computerized tomography (CT) scan. 2. Able and willing to give written informed consent and comply with the requirements of the study protocol. 3. Female participants of child bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at check-in. 4. Male participants with female partners of child-bearing potential must agree to abstinenceif this is in line with the usual lifestyle, or to use condoms plus partner use of an acceptable contraceptive for the duration of the study and until 4 weeks after dosing with the study drug. 5. Patients will to cooperate and give consent for the trial and comes for regular follow up.

Exclusion criteria

Exclusion criteria: 1. Patients with complications and requiring surgical interventions. 2. Patients with high values of serum creatinine, serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase, alkaline phosphatase and HbA1c at screening. 3. Any systemic disease requiring other medications of surgery for calculus condition. 4. Complicated cases of Renal calculi requiring surgical condition. 5. Chronic or current infectious diseases such as but not limited to chronic renal infection, Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris , myocardial infarction.

Design outcomes

Primary

MeasureTime frame
Evaluation of expulsion and change in size and density of renal calculi assessed by CT scanTimepoint: Baseline(Day 1) to EOT—

Secondary

MeasureTime frame
1.Evaluation of change in pain intensity by visual analog scale (VAS) 2. Evaluate the tolerability of IP. 3. Assessment of rate of incidence of AEs and SAEs.Timepoint: Baseline (Day 1) to EOT—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt Ltd

harish@icbiocro.com9900111997

Outcome results

None listed

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