Clinical study of Unani drug in kidney stone
- Conditions
- Health Condition 1: N200- Calculus of kidney
- Registration Number
- CTRI/2019/07/020305
- Lead Sponsor
- Central Research Institute of Unani Medicine Hyderabad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Patients of any sex aged 18-65 years
2) Patients with HasÄ?h al-Kulya (nephrolithiasis) diagnosed by Plain X-Ray Abdomen (KUB)/ Ultrasound Abdomen
3) Stone in Renal Pelvis with size ranging from 5-9 mm
4) Patients with or without any of the following symptoms:
-Bawl al-Dam (Haematuria)
-Siql al-KhÄ?sira (Heaviness in the Loin)
-Wajaâ?? al-KhÄ?sira (Pain in the Loin)
-Urine showing Calcium Crystalluria
-History of Recurrent UTI
-History of Recurrent Nephrolithiasis
5) Patients willing to give written informed consent
6) Patients willing to comply with the requirements of the study protocol
1) Patients aged less than 18 or more than 65 years
2) Patients having acute renal colic
3) Complicated cases of nephrolithiasis requiring surgical intervention
4) Patients with hydronephrosis, acute symptoms of UTI or any other kidney disease, including serum creatinine level more than 1.5 x ULN or eGFR less than 60 mL/min
5) Liver dysfunction, defined as serum bilirubin more than 1.5 x ULN, SGOT (AST) or SGPT (ALT) more than 2.5 x ULN
6) Known cases of significant cardiac/ pulmonary dysfunction or immunocompromised states (HIV/ AIDS, etc.)/ malignancies
7) Patients on long-term medications
8) Pregnancy and lactation
9) Currently active alcohol or drug abuse/ history of alcohol or drug abuse within 6 months prior to baseline
10) Known sensitivity to study medication or any of its ingredient
11) Patient not willing to attend treatment schedule regularly
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Stone Size on Ultrasound (KUB) <br/ ><br>2) Renal Pain and Loin Heaviness <br/ ><br>3) Visual Analogue Scale (VAS) <br/ ><br>4) Relief in Bawl al-Dam (Haematuria) <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: USG at Baseline and 8th week. <br/ ><br>Rest at Baseline, 2nd week, 4th week, 6th week, 8th week <br/ ><br>
- Secondary Outcome Measures
Name Time Method ab InvestigationsTimepoint: Baseline and after treatment.