Health Condition 1: N200- Calculus of kidney
Conditions
Interventions
Intervention1: Dabur Ayurvedic Formulation: The product is recommended for use in Mutrasharmi (Urinary stone) and other urinary
tract disorders. The current study is planned for evaluating the effect
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females of age 18-65 years (both inclusive) 2. Renal stone diagnosed by X-ray KUB and USG abdomen and Pelvis 3. Patients having renal stone(s) greater than 05 mm and less than 12 mm in size 4. Patients with or without symptoms such as hematuria, dysuria, pain in abdomen, and burning micturition 5. Patient not taking any other lithotriptic agent 6. Patient able and willing to give written informed consent and comply with the requirements of the study protocol 7. 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 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. Patients with any other known urogenital disorders 9. Patients on herbal supplements for renal stone disease (plant extracts preparations or herbal medicines etc.) within previous 15 days 10. Patients participated in another clinical drug study within 3 months before recruitment 11. Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation 12. Pregnant and breast feeding women 13. Patients with clinically significant abnormal laboratory findings. 14. Subjects who refuse to sign the informed consent document 15. Chronic Alcoholics 16. Immunologically compromised individuals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes: 1. Reduction in stone(s) size 2. Reduction in number of stonesTimepoint: subjects are assessed for reduction in stone size and number of stone at last visit in comparison with base line but Subject will be called to the hospital for follow up visits on day 15 (Visit I), day 30 (Visit II), day 45 (Visit III), day 60 (Visit IV), day 75 (Visit V)day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of number of patients with complete expulsion of stone(s), duration of expulsion of calculi, use of NSAIDs/ Anti-spasmodic drugs as rescue medicines, overall Improvement in clinical symptoms: Pain in abdomen, Hematuria, Burning micturition, Pain during micturition, Pain Episodes, Frequency of micturition drug safety by assessing ( Adverse drug reaction & Clinically significant Laboratory abnormalities)Timepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Dabur India Limited
Outcome results
None listed