| CTRI Number |
CTRI/2020/02/023293 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
03/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of litholytic property of Japa Pushpa Churna in Cholelithiasis. |
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Scientific Title of Study
|
A Randomized controlled trial to evaluate the litholytic property of Japapushpa churna in Ashmari w.s.r. to Cholelithiasis
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mita Kotecha |
| Designation |
Proffesor and HOD |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Dravyaguna vigyan National Institute of Ayurveda
Madhav Vilas Palace Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078872 |
| Fax |
|
| Email |
mita@ayu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mita Kotecha |
| Designation |
Proffesor and HOD |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Dravyaguna vigyan National Institute of Ayurveda
Madhav Vilas Palace Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078872 |
| Fax |
|
| Email |
mita@ayu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Prakash |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Dravyaguna vigyan National Institute of Ayurveda
Madhav Vilas Palace Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461427437 |
| Fax |
|
| Email |
dr.raviprakash86@gmail.com |
|
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Source of Monetary or Material Support
|
| National Institute of Ayurveda Madhav Vilas Palace Amer Road Jaipur
Rajasthan 302002 |
|
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Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace Amer Road Jaipur 302002 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Prakash |
National Institute of Ayurveda Hospital Jaipur |
OPD or IPD Department of Shalya Tantra
National Institute of Ayurveda Jaipur
SSBH and Satellite hospital Jaipur
Jaipur
RAJASTHAN |
9461427437
dr.raviprakash86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Japapushpa Churna |
Patients will be given Japapushpa Churna 5 grams, twice in a day with lukewarm water, 2 hours after the meal for three months trial period or till the dissolution of the stone whichever is earlier. |
| Comparator Agent |
Ursodeoxycholic Acid (UDCA) |
Patients will be given UDCA with 8-10 mg/kg per day in two divided doses (Tab. Udigal 300mg) after meal for three months or till the dissolution of the stone whichever is earlier
Patients who are unable to tolerate tablet will be started on UDCA syrup at the same dose(8-10 mg/kg per day in two divided doses). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Gall stone resolution rate at 6th and 12th week will be evaluated by USG in all patients |
6th and 12th week |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
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))
|
6th and 12th week |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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 15 mm 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 reference available 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.
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