A clinical trial to study the effects of two drugs Tila-Dhatri kshara along with Gokshura kashaya and Potassium Magnesium Citrate B6 in patients with Kidney stones.
- Conditions
- Calculus of kidney and ureter. Ayurveda Condition: MOOTRASHMARI,
- Registration Number
- CTRI/2020/11/029011
- Lead Sponsor
- CCRAS
- Brief Summary
This study is a Non-randomized Active controlled trial to be conducted in 70 patients of Urolithiasis coming to the OPD of Sir Sunderlal Hospital ,IMS,BHU, Varanasi, Uttar Pradesh, India. The study is aimed at comparing the efficacy of ayurvedic drug with an allopathic drug. The 70 patients will be consecutively allocated in 2 groups of 35 patients each. One group will be given Tila-Dhatri kshara capsules 500mg along with Gokshura kashaya 48ml twice daily morning and evening before food for 45 days. The second group will be given Potassium Magnesium Citrate-B6 1500mg tablet twice daily morning and evening after food for 45 days. The primary outcome is lithotriptic activity which will be assessed by STONE score got through Non-Contrast CT scan on 0th and 46th day of drug administration. The SFR( Stone Free Rates ) is inversely proportional to the STONE score. The secondary outcome is subjective like Pain, Haematuria and Burning micturition. It will be assessed on 0th, 15th, 30th and 45th day of drug administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 70
- Patients presenting with signs and symptoms of Urolithiasis confirmed radiologically.(stone size < 10mm) 2.
- Patients in the age group 18 – 70 yrs.
- Patients of either sex.
- Patients with informed consent.
- Stag horn renal calculi 2.
- Pyelonephritis 3.
- Uncontrolled diabetes mellitus 4.
- Malignancy 5.
- Chronic renal failure 6.
- Severe UTI 7.
- Calculus associated with complications 8.
- Calculi > 10mm 9.
- Bladder stones 10.
- Any other systemic symptoms like hyperparathyroidism, gout etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lithotriptic activity using S.T.O.N.E score assessed via NCCT Scan 0th day and 46th day Obstruction 0th day and 46th day Number of stones 0th day and 46th day Evaluation of Hounsfield units 0th day and 46th day Size 0th day and 46th day Topography 0th day and 46th day
- Secondary Outcome Measures
Name Time Method Pain using Wong-Baker Faces pain scale Haematuria
Trial Locations
- Locations (1)
Ayurveda wing, Sir Sunderlal Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Ayurveda wing, Sir Sunderlal Hospital🇮🇳Varanasi, UTTAR PRADESH, IndiaDr Neethu VijaiPrincipal investigator9496077201neeethurajeeev@gmail.com