STUDY TO EVALUATE THE EFFECT AND SAFETY OF AN AYURVEDIC DRUG (URAL CAPSULE) IN RENAL STONES

Phase 2

Recruiting

Conditions: Patients suffering from Stones in Kidney, Ureters and Urinary Bladder

Registration Number: CTRI/2018/07/014706

Lead Sponsor: National Institute of Ayurveda

Brief Summary: Stone formation in kidney is one of the oldest and the mostwidespread medical afflictions known to humans. It is a most common urinarytract problem all over the world, having prevalence rate of 2.3%. Patientsbetween ages of 20-50 years have peak incidence of stone formation. In India,6-8% population suffers from kidney stone. Ural Capsule is a patent &proprietary Ayurvedic formulation, recommended for treatment of urolithiasis.Previous experimental data has confirmed its safety and efficacy. Hence thepresent study is to be initiated to evaluate its clinical safety and efficacy.Open labelled, interventional clinical trial protocol has been designed toevaluate efficacy and safety of Ural Capsule in treatment of urolithiasis.Inclusion and exclusion criteria have been mentioned in protocol for selectionof patients. All selected patients will be treated with Ural Capsule for 3months (12 Weeks). For the assessment of efficacy different clinical parameterssuch as subjective parameters, Blood urea, Serum uric acid, Serum creatinine,X-ray (KUB) & Ultrasonography (KUB) will be considered. Routinehaematological parameters, routine urine analysis and routine stool analysiswill be done to evaluate safety of the drug. Follow-up visit will be scheduled at1 month interval after compilation of treatment up to 2 months. Appropriatestatistic will be applied to find out statistical significance level.

**KeyWords :** Ashmari,Urolithiasis, Kidney stones, Uralcapsule**.**

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 60

Inclusion Criteria

(1) Patients of both sexes in the age group of 18 to 60 years will be selected for the present study.
(2) Patients who willing to sign written consent and comply with the study procedure.
(3) Patients having stone in kidney / ureter / bladder (KUB) greater than 5 mm but < 12 mm in size.

Exclusion Criteria

(1) Patients below 18 years and above 60 years (2) Patients having uretero-hydronephrosis, diabetes, ulcer disease, history of hypersensitivity to herbal formulation (3) Patients suffering from serious systemic disorders (4) Patients with severe complication and requiring immediate surgery (5) Pregnant or lactating women (6) Patients who are unwilling to give informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of trial drug on urolithiasis	3 months clinical trial and 2 months follow up

Secondary Outcome Measures

Name	Time	Method
Safety of the trial drug	During treatment and in follow up

Trial Locations

Locations (1): Campus Hospital, National Institue of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
Campus Hospital, National Institue of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Ashok Kumar
Principal investigator
9649180572
ashok_hp1976@yahoo.com