Health Condition 1: K808- Other cholelithiasis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ages ranging from 18 yrs. to 60 yrs 2.Those ready to give written informed consent 3.Asymptomatic or mildly symptomatic subjects with sonographic evidence of gallstones of size less than 15 mm in diameter, single or multiple 4.Gall stones, that are radiolucent on Plain abdominal X ray
Exclusion criteria
Exclusion criteria: 1.Current acute cholecystitis 2.Current or previous Obstructive Jaundice or Pancreatitis 3.Current or Previous use of UDCA 4.Known allergy or intolerance to UDCA 5.Existence of concurrent hepatic diseases 6.Participation in another study 7.Uncontrolled Hypertension and Diabetes Mellitus 8.Chronic alcoholics 9.HIV, HBsAg Positive patients 10.Mentally ill patients 11.Pregnancy or Lactation 12.Any other laboratory or clinical condition that could impact the outcome of the study or the safety of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gall stone resolution rate at 6th and 12th week will be evaluated by USG in all patientsTimepoint: 6th and 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in number and severity of episodes of mildly symptomatic gallstones 2.Rate of surgical intervention 3.Sonographic improvement (size and number, presence of bile sludge, gallbladder wall thickness). 4.Evaluate tolerability and adverse effects of UDCA therapy and Japapushpa churna (including non-specific abdominal discomfort, rash or nausea) 5.Improvement in biochemical evidence of gallstone disease. (Reduced gamma-glutamyl-transpeptidase (GGT) and alkaline phosphatase (ALP)) Timepoint: 6th and 12th week | — |
Countries
India
Contacts
National Institute of Ayurveda