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An open labelled randomised comparative clinical and in vitro study to evaluate the effect of Pashanabhedadi kashaya ghana capsule and Pashanabheda kashaya ghana capsule in the management of Mootrashmari vis-Ã -vis Nephrolithiasis

Phase 3
Not yet recruiting
Conditions
Calculus of kidney,
Registration Number
CTRI/2023/05/053091
Brief Summary

Background of the study:

Nephrolithiasis or calculi formation in kidneys, is a common problem worldwide,  with prevalence of 7% in the adults and > 30% recurrence  rate within 10years. The incidence  of Nephrolithiasis is globally increasing with an estimated prevalence ranging up to 15%. During lifetime, approximately 7% of women and 13% of men will develop a kidney stone. In Indian population, about 12% of them are expected to have urinary stones and  out of which 50% may end up loss of kidney functions. Invasive therapies for removal of calculi such as ESWL ( Extra corporeal shock wave  Lithotripsy). PCNL (Percutaneous nephrolithotripsy), Basketing therapy, Pylolithotomy are commonly for the management of Nephrolithiasis . Features of Nephrolithiasis are closely similar to the disease Mootrashmari in the Ayurveda parlance and majority of the pathology in both the condition are similar.

Purpose of the study:

In spite of technological advances in the field of  medicine and surgery conservative therapy still continues to a solution for all reversible ailments. Even though invasive therapies are one of the  alternatives used commonly for the management of Nephrolithiasis , however these therapies  have their  own disadvantages and complications. Kshara, kashaya  and churna  yogas  are frequently used  forms of medicines, palatability is major challenges. Considering the magnitude of the condition at present, there is a need of widely acceptable, evidence based, cost effective, easily available, simple, safe and single drug for Nephrolithiasis.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

Diagnosed cases of Mootrashmari vis-Ã -vis Nephrolithiasis as per the diagnostic criteria Patients with solitary or multiple renal calculi with size less than or equal to 10 mile meter size Participants are willing to provide informed consent.

Exclusion Criteria

Patients with associated obstructive pathologies like BPH urethral stricture and congenital anatomical abnormalities Renal calculi in associated with uretreric bladder or uretral calculi During the phase of Renal colic and Ureteric colic Patients with severe Hydronephrosis Pregnant women and lactating mothers Systemic diseases which interfere with disease process and present clinical trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
EXPULTION OF KIDNEY STONESAT 45TH DAY
Secondary Outcome Measures
NameTimeMethod
IMPROVEMENT OF QUALITY OF LIFEbased on a questionnaire

Trial Locations

Locations (1)

SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA KUTHPADY UDUPI KARNATAKA

🇮🇳

Udupi, KARNATAKA, India

SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA KUTHPADY UDUPI KARNATAKA
🇮🇳Udupi, KARNATAKA, India
DR SHAILESH Y
Principal investigator
08202520332
drshayayu@gmail.com

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