A Clinical study to evaluate the efficacy of Ayurvedic drug in the treatment of renal stones

Phase 2/3

Not yet recruiting

• Conditions: Calculus of kidney with calculus of ureter. Ayurveda Condition: MUTRAVAHASROTOVIKARAH,

• Registration Number: CTRI/2023/03/051228
• Lead Sponsor: Ashok Devidas Pawar

Brief Summary

TITLE- A Randomized Controlled Clinical Trial To Study The Efficacy Of Kadali Kwath In Comparison With Varunadi Kwath In The Management Of Mutrashmari

Null Hypothesis H0 – Kadali Kwath is as effective as Varunadi Kwath in the management of Mutrashmari

Alternate Hypothesis H1- Kadali Kwath is more effective than Varunadi Kwath in the management of Mutrashmari

Study design: Randomized controlled Clinical trial.

Inclusion Criteria : 1) Patients having signs and symptoms of Mutrashmari. 2) Urolith of size up to 12 mm. 3) Genders : Both Males and females 4) Patients between age group 18 to 60 years will be included. 5) Urolith seen in urinary tract as per USG.

Exclusion Criteria : 1) Seriously ill patients. 2) Obstructive uropathy leading to gross hydronephrosis, renal function impairment. 3) Pyonephrosis, 4) CA of urinary tract. 5) Gross hematuria.(Visible blood in the urine) 6) Having Urolith of size more than 12mm. 7) Pregnant and lactating women. 8) Patients with no symptoms of mutrashmari

Sample Size -Total 70 (35 For each Group)

Patients coming in IPD And OPD of Shalyatantra department of research institute hospital and working hospital, with complaint of mutrashmari. Simple Randomized Sampling. (Lottery Method).

Group A – Kadali Kwath Group B – Varunadi Kwath Total duration of drug administration is 30 days. The mode of drug administration will be by oral route in the form of Liquid. Dietary support and oral hydrotherapy will be given in both groups. FOLLOW UP: Patient will be investigated on fifteenth & thirtieth day.

Results-Result will be drawn on the basis of criteria of assessment and Statistical Analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

• 1. Patients having signs and symptoms of Mutrashmari.
• 2. Urolith of size up to 12 mm.
• 3. Genders : Both Males and females 4) Patients between age group 18 to 60 years will be included.
• 5. Urolith seen in urinary tract as per USG.

Exclusion Criteria

• 1. Seriously ill patients.
• 2. Obstructive uropathy leading to gross hydronephrosis, renal function impairment.
• 3. Pyonephrosis, 4) CA of urinary tract.
• 5. Gross hematuria.(Visible blood in the urine) 6) Having Urolith of size more than 12mm.
• 7. Pregnant and lactating women.
• 8. Patients with no symptoms of mutrashmari.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the effect of Kadali Kwath in comparison with Varunadi Kwath in the management of Mutrashmari/ Urolithiasis	Duration of treatment 30 days | Follow up on 15th and 30th days

Secondary Outcome Measures

Name	Time	Method
To assess the effect of Kadali kwath in Mutrashmari( Renal and Ureteric stone) with expulsion of stone	Duration of treatment 30 days

Trial Locations

Locations (1)

Tarachand Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Tarachand Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Ashok Devidas pawar

Principal investigator

9822285836

dr.ashok2575@yahoo.com