Clinical trial to study safty and efficacy of herbmed plusin patient with renal calculi

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: HERBMED PLUS: 500 MG TWICE DAY FOR 6 MONTH Control Intervention1: PLACEBO: 500 MG TWICE A DAY WITH LUNCH AND DINNER CONDITION: RENAL CALCULI or Kidney stones PRIMARY OUTCOME: To evaluate the efficacy of Herbmed plus in patients with urinary calculi by assessing the reduction in the stone size & surface area/ or the expulsion of stone‐‐‐‐‐‐Timepoint: 210 DAYS SECONDARY OUTCOME: To evaluate the safety and tolerability of Herbmed plus in the management of urinary calculi. Reduction in pain& Consumption of Analgesics‐‐‐‐‐‐Timepoint: 210 DAYS INCLUSION CRITERIA: 1. Age 18‐75 years (Both inclusive) 2. Patients with Renal calculi, diagnosis confirmed by plain X‐ray KUB &/or ultrasound KUB/CT scan Kidney 3.Size of the calculi ranging from 04 mm ‐09 mm 4.Able and willing to give written informed consent and comply with the requirements of the study protocol 5.Patients of reproductive potential (males and females) and willing to use a reliable means of contraception (e.g hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation
Epistemonikos ID: 2a56d876b2857e3515193a96f7b6bd8ecb008194
First added on: Aug 22, 2024