| CTRI Number |
CTRI/2018/03/012396 [Registered on: 07/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
effect of ayurvedic drug in gall stone |
|
Scientific Title of Study
|
To Evaluate The Efficacy Of Ayurvedic Compound In Hepatobilliary Lithiasis With Special Reference To The Histological Changes & The Biochemical Analysis Of Bile |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Gangwar |
| Designation |
P.G.Scholar |
| Affiliation |
institute of medical sciences, BHU |
| Address |
Dept of Shalya Tantra, Faculty of Ayurveda, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9473837902 |
| Fax |
|
| Email |
gangwarprachi6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshman Singh |
| Designation |
Professor |
| Affiliation |
institute of medical sciences, BHU |
| Address |
Dept of Shalya Tantra, Faculty of Ayurveda, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415687065 |
| Fax |
|
| Email |
drlsingh@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Gangwar |
| Designation |
P.G.Scholar |
| Affiliation |
institute of medical sciences, BHU |
| Address |
Dept of Shalya Tantra, Faculty of Ayurveda, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9473837902 |
| Fax |
|
| Email |
gangwarprachi6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sundar Lal Hospital,Banaras Hindu University, Varanasi |
|
|
Primary Sponsor
|
| Name |
IMS BHU |
| Address |
Department of Shalya Tantra,
Faculty of Ayurveda,
IMS, BHU, Varanasi. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prachi Gangwar |
sir sundar lal hospital |
Faculty of Ayurveda,Dept of Shalya Tantra ,IMS,BHU
Varanasi
UTTAR PRADESH |
9473837902
gangwarprachi6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
USG diagnosed Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with symptoms like
1.pain in right upper quadrant of abdomen, 2.referring pain to the inferior angle of scapula,
3. vomiting,
4. nausea,
5. flatulent dyspepsia,
6.recurrent indigestion and
7. also asymptomatic patients who are diagnosed to have gallstones, accidentally by USG. |
|
| ExclusionCriteria |
| Details |
1.Patients with gallstones associated with complication such as carcinoma of gallbladder, liver failure, acute pancreatitis.
2.Uncontrolled other systemic disorders.
3.Child age group
4.Pregnant lady
5.Immunocompromised patients.
6.HIV & HbsAg +ve patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| LFT, Histopathological changes, Bile analysi |
0ne month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/12/2016 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The studt is non randomised, open label, placebo control, single centre trial to evaluate the efficacy of an ayurvedic compound in hepatobiliary lithiasis w.s.r to histopathologigal changes and biochemical analysis of bile. |