Evaluation of litholytic property of Japa Pushpa Churna in Cholelithiasis.

Phase 2

Not yet recruiting

Conditions: Other cholelithiasis,

Registration Number: CTRI/2020/02/023293

Lead Sponsor: National Institute of Ayurveda

Brief Summary: Gallstone is a common cause of abdominal pain, and its prevalence ranges from 5% to 15% among general population. Approximately 1% to 2% of patients become symptomatic every year, and biliary complications occur in approximately 3% of patients after 10 years. Once the patient becomes symptomatic, recurrent biliary pain develops in 38% to 50% of cases. Therefore, cholecystectomy is the standard treatment for symptomatic gallstone disease. However, cholecystectomy cannot always be performed because of severe comorbidity or at times because of patient refusal. In these patients, oral litholysis could be considered if they meet the currently accepted standard criteria for gallstone dissolution: gallstones less than 15â€Šmm in diameter, radiolucent on plain abdominal x-ray and asymptomatic or mildly symptomatic patients.

*Ashmari* is formed when *bastigata sukra, mutra, pitta*,and *kapha* vitiated and dried by *vatta dosha* at their place in the same manner of *gorochana* formation in the *pittasye* of cow. Hence, it is described the formation of *pittashashmari* in animals. However, there is no any direct referenceavailable in ayurvedic texts regarding the formation of *pittashmari* in human being.

Ursodeoxycholic acid (UDCA) is already an established medicine as a dissolution agent for cholelithiasis and *Japa pushpa churna* has been using in folklore to treat renal calculi and gallstones but still no research work has been done to evaluate the safety and efficacy of this drug.

Hence the current clinical study is proposed to evaluate and compare the litholytic property of *Japapushpa churna* over the conventional oral medicine, Ursodeoxycholic Acid (UDCA) which is taken as a control comparator in the management of Cholelithiasis.

**AIM:** The aim of the present two-armed randomized trial is to compare *Japapushpa churna* and UDCA in Cholelithiasis.

**OBJECTIVES:**

**2.1. Primary Objectives:** To evaluate the litholytic property of *Japapushpa churna* on gallstones in compared to the control, UDCA

**2.2. Secondary Objectives:** To determine the safety and tolerability of *Japapushpa churna* and UDCA in the subjects with Gallstones.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gall stone resolution rate at 6th and 12th week will be evaluated by USG in all patients	6th and 12th week

Secondary Outcome Measures

Name	Time	Method
1.Improvement in number and severity of episodes of mildly symptomatic gallstones	2.Rate of surgical intervention

Trial Locations

Locations (1): National Institute of Ayurveda Hospital Jaipur
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda Hospital Jaipur
🇮🇳Jaipur, RAJASTHAN, India
Dr Ravi Prakash
Principal investigator
9461427437
dr.raviprakash86@gmail.com