Clinical study on Ayurine Plus Capsules Kidney stone

A Randomized, Open Labeled, Multicenter, prospective, Clinical study to Evaluate efficacy and safety of AYURIN Plus Capsule in comparison with marketed Ayurvedic Formulation CYSTONE (Himalaya) in Urolithiasis" - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010768

Enrollment

Registered

2017-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: N209- Urinary calculus, unspecified

Interventions

Intervention1: AYURINE Plus Capsules: Contains Trubulus Terrestris extract, Bergenia Ligulata extract, Crataeva Nurvala extract, Dolichos Biflorus, Boerhaavia Diffusa, Vetiveria Zizaniodes, Sida Cordi

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.Reduction in stone(s) size 2.Reduction in number of stones Timepoint: Day-3, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90	—

Secondary

Measure	Time frame
1. Assessment of number of patients with complete expulsion of stone(s). 2. Assessment of duration (time) of expulsion of calculi. 3. Assessment of use of NSAIDs/ Anti-spasmodic drugs as rescue medicines. 4. Assessment of overall improvement in clinical symptoms : 5. Assessment of Drug Safety by assessing: a. Adverse drug reaction. b. Clinically significant Laboratory abnormalities. Timepoint: Day-3, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90	—

Measure

Time frame

1. Assessment of number of patients with complete expulsion of stone(s). 2. Assessment of duration (time) of expulsion of calculi. 3. Assessment of use of NSAIDs/ Anti-spasmodic drugs as rescue medicines. 4. Assessment of overall improvement in clinical symptoms : 5. Assessment of Drug Safety by assessing: a. Adverse drug reaction. b. Clinically significant Laboratory abnormalities. Timepoint: Day-3, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90

—

Countries

India

Contacts

Public ContactVandana Bade

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results

None listed

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