Clinical Study on DaburAyurvedic formulation for its effect on Kidney stones
- Conditions
- Health Condition 1: N200- Calculus of kidney
- Registration Number
- CTRI/2014/08/004888
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes: <br/ ><br>1. Reduction in stone(s) size <br/ ><br>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 <br/ ><br>(Visit I), day 30 (Visit II), day 45 (Visit III), day 60 (Visit IV), day 75 <br/ ><br>(Visit V)day 90
- Secondary Outcome Measures
Name Time Method 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, <br/ ><br>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