Clinical study on Ayurine Plus Capsules Kidney stone
- Conditions
- Health Condition 1: N209- Urinary calculus, unspecified
- Registration Number
- CTRI/2017/12/010768
- Lead Sponsor
- Welex Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
1.Patients having renal stone(s) greater than 05 mm and less than 12 mm in size.
2.Renal stone diagnosed by X-ray KUB and USG (abdomen and Pelvis).
3.Patients with or without symptoms such as hematuria, dysuria, pain in abdomen, and burning micturition.
4.Patient not taking any other lithotriptic agent.
5.Patient able and willing to give written informed consent and comply with the requirements of the study protocol.
6.Females of reproductive potential willing to use a reliable means of contraception (e.g. hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation.
1.Patients having acute renal colic.
2.Patients with stone in lower calyx.
3.Patients with moderate to severe uretero-hydronephrosis.
4.Complicated cases of Renal Calculi requiring surgical intervention.
5.Chronic renal failure.
6.Patients having clinically significant urinary tract infections.
7.Patients with known uncontrolled diabetes mellitus (DM), hypertension (HT), symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI).
8.Pregnant and breast feeding women.
9.Patients with clinically significant abnormal laboratory findings.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method