| CTRI Number |
CTRI/2020/12/030102 [Registered on: 29/12/2020] Trial Registered Prospectively |
| Last Modified On: |
25/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Pashanbhedadi Churna in the Ashmari management |
|
Scientific Title of Study
|
Efficacy of Pashanbhedadi Churna in the management of Ashmari(Renal Calculi)-An open Labelled Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hetal G Koriya |
| Designation |
MS 1st Year |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Shalyatantra Department 6th floor IPGT RA Jamnagar
Opd no 1 Sushrut Bhavan IPGT RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9033785547 |
| Fax |
|
| Email |
hetalkoriya66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T S Dudhamal |
| Designation |
Associate Professor |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Shalyatantra Department 6th floor IPGT RA Jamnagar
Opd no 1 Sushrut Bhavan IPGT RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
dudhamal@ayurveduniversity.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T S Dudhamal |
| Designation |
Associate Professor |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Shalyatantra Department 6th floor IPGT RA Jamnagar
Opd no 1 Sushrut Bhavan IPGT RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
dudhamal@ayurveduniversity.com |
|
|
Source of Monetary or Material Support
|
| Institute for post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for post graduate and research center |
| Address |
Gujarat Ayurved University Jamnagar |
| 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 |
| Hetal G Koriya |
Shalya Tantra Department OPD No.1,IPGT and RA,JAMNAGAR |
6th Floor, Shalya Tantra Department
Jamnagar
GUJARAT |
9033785547
hetalkoriya66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:3||Administration. Ayurveda Condition: ASMARI, (2) ICD-10 Condition: N200||Calculus of kidney, (3) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: Ashmari(Renal Calculi), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashmarihar Kwath |
Group A patient will be treated with Ashmarihar kwath for 60days 10gm yavkut BD |
| Comparator Agent |
Pashanbhedadi Churna |
Group B patient will be treated with Pashanbhedadi Churna for 60days 5gm BD |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
stone size upto 10mm
patients of Ashmari with controlled HTN and DM
case of only renal stone will be included |
|
| ExclusionCriteria |
| Details |
age below 18 and above 60years
chronic renal failure( Sr.Creatinine>2mg/dl not included)
gross hydronephrosis
acute abdominal pain
cases which require surgical intervention
severe haematuria
stone size>10mm
stone present in urinary bladder,ureter,urethra
known cases of malignancy and tuberculosis
uncontrolled HTN,DM,Cardiac disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in Signs and Symptoms of Renal Calculi
Reduction in Stone Size
Expelled out of Stone |
Outcome will be assessed after 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve Quality of Life of Person |
Assessment will be done after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/01/2021 |
| Date of Study Completion (India) |
14/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
total 50 patients were divided into two groups by randomization.among them 8 patients were dropped out.in group A patients were treated with Ashmarihaara Kwatha and Yava Kshara and in group B patients were treated with Pashanbhedadi Churna for 60 days with follow up of 30 days.at the end of the study sifnificant result was found in group A Iin both subjective and objective parameters while better result was found in subjective parameter in group B and both the drugs also showed good result in positive urine culture. |