A Clinical study to evaluate the efficacy of a Unani formulation in the management of Urolithiasis

Phase 2

Completed

• Conditions: Calculus of kidney with calculus of ureter, (2) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter,

• Registration Number: CTRI/2023/09/057301
• Lead Sponsor: Ayurvedic and Unani tibbia college and and hospital karol bagh new delhi-110005

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-14
• Study Start: 2023-09-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
effect of a mineralo- herbal Unani formulation in reducing the size of renal stone size will be assessed on USG.	Baseline, 42nd day

Secondary Outcome Measures

Name	Time	Method
Flank pain, dysuria, frequency & nausea/vomiting will be assessed.	Baseline, 10th day, 20th day, 30th day & 42nd day

Trial Locations

Locations (1)

Ayurvedic and Unani tibbia college and hospital; 🇮🇳 Central, DELHI, India

Ayurvedic and Unani tibbia college and hospital

🇮🇳Central, DELHI, India

Km Antim varun

Principal investigator

9718381517

varun.antim@gmail.com