Health Condition 1: N209- Urinary calculus, unspecified Health Condition 2: null- urolithiasis
Conditions
Interventions
Intervention1: IBHB tablets: IBHB tablets (300 mg, one tablet, twice a day orally) for 12 weeks
Control Intervention1: Placebo tablets: Placebo tablets (300 mg, one tablet, twice a day orally) for 12
Sponsors
Indus Biotech Private Limited Pune
Eligibility
Inclusion criteria
Inclusion criteria: 1) Males or females aged 18 to 65 years, both inclusive.2) Symptomatic and asymptomatic cases with radiographic evidence (abdominal USG report up to two weeks prior to screening will be accepted) of diagnosis of renal calculi 3) In case of subjects with multiple calculi, at least one calculus must be 5 mm and all calculi should be 10 mm 4) Subjects willing to refrain from the use of any other herbal treatment for urolithiasis during the entire course of the study 5) Subjects willing to adopt a reliable and effective method of contraception during the course of the study such as abstinence, oral contraceptive pills, barrier method, etc 6) Subjects willing to provide a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects with urinary tract infection 2) Subjects with obstructive uropathy 3) Subjects with known metabolic or endocrinal disorders favouring calculus formation 4) Subjects with known history of hypersensitivity to lactose 5) Subjects with malignancy 6) Subjects with poorly controlled diabetes as observed by a HbA1c of >10% 7) Subjects suffering from chronic systemic illnesses like rheumatoid arthritis,psychoneural-endocrinal disorders, etc necessitating long term therapy 8) Subjects with a history of atrial fibrillation, coronary artery disease, acute coronary syndrome,myocardial infarction, stroke or severe arrhythmia in the past 6 months 9) Subjects with poorly controlled hypertension, as observed by a blood pressure (BP) reading of >160/100 mm Hg in the supine position 10) Subjects on prolonged treatment with corticosteroids, antidepressants, anticholinergics, etc or any other medication that may have an influence on the outcome of the study. Subjects should not have consumed any of these for at least six weeks prior to screening 11) Subjects with severe hepatic disorder, defined as AST, ALT, total bilirubin, and ALP levels >2 times ULN or renal disorder, defined as serum creatinine levels >1.2 mg/dL 12) Subjects with severe pulmonary dysfunction such as uncontrolled bronchial asthma and/or chronic obstructive pulmonary disease, inflammatory bowel disease, or any other condition which could influence the outcome of the study 13) Subjects who are currently dependent on or abusing, alcohol or one or more of the following: cannabis, cocaine, hallucinogens, inhalants, opioids, sedatives or hypnotics 14) Subjects with known hypersensitivity to the investigational product or its ingredients 15) Subjects with a history of food allergy 16) Subjects with known allergy to diclofenac sodium 17) Subjects who have participated in any other investigational study in the past 6 months 18) Subjects with known HIV, Hepatitis B or Hepatitis C infections 19) Subjects with a positive pregnancy test at screening or who is a lactating female 20) Subjects with any medical condition that in the investigatorâ??s opinion may threaten the subjectâ??s ability to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with reduction in the size of renal calculus/calculi as compared to baseline between the groupsTimepoint: At randomization visit (baseline) and at 12 week (end of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Proportion of subjects with reduction in the size and complete expulsion of renal calculus 2)Reduction in the diameter of largest renal calculus, number and sum of diameters of renal calculi 3)Change in the pH of urine and estimated creatinine clearance 4)Change in pain by VAS scores, number, amount of analgesics consumed 4)QoL by KDQOL-SFâ?¢ 5)Safety in terms of number of drop-out subjects, number of patients with UTI, incidences of AEs, physical examination, vital signs and lab parametersTimepoint: At randomization visit (baseline) and at 12 week (end of study) | — |
Countries
India
Contacts
Public ContactPallavi Deshpande
Indus Biotech Private Limited
Outcome results
None listed