To assess the effect of Ayurvedic medicines on Kidney stone (urolithiasis)

Phase 2/3

Completed

Brief Summary: The word Ashmari has been derived form the Sanskritword â€˜Asmanâ€™which literally means a structure resembling stone. Mutrashmari (urolithiasis) is the condition where urinary calculi are formed or located anywhere in the urinary system. It is a common cause of haematuria, abdominal pain, pain in flank or groin.

Detailed description of â€˜Mutrashmariâ€™concerning aetiopathogenesis,clinical features and line of treatment is available in ancient classics ofAyurveda.

1% of the patients visiting hosptals inIndia presents the symptoms of Urolithiasis. Due to unwholesome diet and livinghabits aggravated Kapha, reaches in urinary tract and dries up to form the calculus. Thoughthere are some popular methods like Extra-corporial shock wave lithotripsy and percutaneous nephro-lithotripsyin conventional medicine but have definite side effects like UTI, blockage in ureterwhich in turn causes kidney damage and PNCL. VariousAyurvedicclassical formulations are being used successfully in the management of Mutrashmari byAyurveda physicians since centuries. The present clinical trial is proposed to re-evaluate the therapeutic efficacy and clinical safety of Varunadi kwath churna and Apamara Kshara in the management of Mutrashmai (urolithiasis) at OPD level in Regional Ayurveda research Institute for urinary disorders, Jammu.

Recruitment & Eligibility

Inclusion Criteria

Patients presenting with or without symptoms of urolithiasis.
Radiological evidence of calculi(upto 10 mm) in kidney/ureter/urinary bladder.
Able and willing to give written consent.
Patients of reproductive potential willing to use a reliable means of contraception.

Exclusion Criteria

Acute condition of renal calculi, UTI 2.
Complicated cases of renal calculi requiring surgical intervention 3.
chronic or current infectious diseases 4.
Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction 5.
Liver dysfunction 6.
Pregnancy or breast feeding.

Primary Outcome Measures

Name	Time	Method
Decrease in the size / number of calculi or expulsion of calculus	3 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline to treatment period in calciuria/oxaluria/citraturia/uricosuria/serum uric acid/calcemia/urine pH. Any episode of renal colic/UTI/complication	2 years

Locations (1): Regional Ayurveda Research Institute
🇮🇳
JAMMU, & KASHMIR, India
Regional Ayurveda Research Institute
🇮🇳JAMMU, & KASHMIR, India
Dr Shah Aaditya Bhavanbhai
Principal investigator
9033236720
dr.aadityashah@gmail.com