CTRI/2014/08/004888已完成2 期
A Randomized, Open Labeled, Multi-center, Prospective,Comparative Clinical Study to evaluate efficacy and safety of Dabur Ayurvedic formulation Stondab, in comparison with marketed Ayurvedic Formulation in Urolithiasis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
排除标准
- •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
- •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
研究者
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