A Clinical study on the management of Urolithiasis with a Unani treatment- An open label single arm study.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- effect of a mineralo- herbal Unani formulation in reducing the size of renal stone size will be assessed on USG.
Study Overview
Brief Summary
This study is an open label single arm study to evaluate the effects of Mineralo-herbal unani formulation and a pharmacopeial syrup in the managenmnt of urolithiasis ,diagnose case of urolithiasis,who fulfil the inclusion/exclusion criteria ,will be enrolled in the trial after making them understand about the study and taking their informed written consent . Patients will be given the treatment under study ,2 capsules (500mg each) along with Sharbat Aloo Baloo(20 ml) twice a day orally .The patients will be followed up on 10th ,20th ,30th ,and 42nd day and will be clinically evaluated on assessment parameters . The data will be statistically analysed by using appropriate statistical tests . The safety of the treatment under study will be ensured by monitoring the Haematological and biochemical indicators for kidney and liver function . Any adverse effects of the treatment during study will be noticed and recorded carefully.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient between the age of 18-65 years of either sex,Diagnosed cases of Urolithiasis with less than or equal to 10mm size, Patient willing to participate and sign the consent form,Patient willing to discontinue the drugs taking for the treatment of Urolithiasis.
Exclusion Criteria
- •Stone size more than 10mm,Stone in the lower pole of kidney and urethra,Patients any anatomical abnormality of urinary tract,Patients with obstruction in urinary passage,Patients with gross hydronephrosis,Patients with pyelonephritis,Patients with diabetes mellitus,Pregnant and lactating women,Renal and hepatic insufficiency and malignancy,Patients unwilling to sign the consent form.
Outcomes
Primary Outcomes
effect of a mineralo- herbal Unani formulation in reducing the size of renal stone size will be assessed on USG.
Time Frame: Baseline, 42nd day
Secondary Outcomes
- Flank pain, dysuria, frequency & nausea/vomiting will be assessed.(Baseline, 10th day, 20th day, 30th day & 42nd day)