| CTRI Number |
CTRI/2018/01/011199 [Registered on: 09/01/2018] Trial Registered Prospectively |
| Last Modified On: |
08/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Mootrashmari Treatment With Palasha Kshara And Ashmarihara Kwatha |
|
Scientific Title of Study
|
Management Of Mootrashmari (Urolithiasis) With Palasha Kshara And Ashmarihara Kwatha - An Open Labelled Controlled Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Kumari |
| Designation |
MS 2 nd Year |
| Affiliation |
Institute for Post Graduate Training And Research Centre |
| Address |
OPD 01 6th floor Department of Shalya Tantra IPGT and RA GAU Jamnagar GUJARAT 361008 India
OPD 01 6th floor Department of Shalya Tantra IPGT and RA GAU Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9506817420 |
| Fax |
|
| Email |
dr.monika19@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T S Dudhamal |
| Designation |
Associate Professor |
| Affiliation |
Institute for Post Graduate Training And Research Centre |
| Address |
6th floor Department of Shalya Tantra IPGT and RA GAU Jamnagar GUJARAT 361008 India
6th floor Department of Shalya Tantra IPGT and RA GAU Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
02882676856 |
| Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T S Dudhamal |
| Designation |
Associate Professor |
| Affiliation |
Institute for Post Graduate Training And Research Centre |
| Address |
6th floor Department of Shalya Tantra IPGT and RA GAU Jamnagar GUJARAT 361008 India
6th floor Department of Shalya Tantra IPGT and RA GAU Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
02882676856 |
| Email |
drtsdudhamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Post Graduate Training And Research In Ayurveda Gujarat Ayurved University Jamnagar Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Training And Research Centre |
| 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 |
| Monika Kumari |
PG Hospital IPGT and RA GAU Jamnagar Gujarat |
OPD No 1 Department Of Shalya Tantra IPGT and RA Hospital Gujarat Ayurved University Jamnagar GUJARAT
Jamnagar
GUJARAT |
9506817420
dr.monika19@rediffmail.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 |
Patient diagnosed with Mootrashmari, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Palasha kshara with Ashmarihara kwath for 60 days |
In Group A , patient will be given Palasha kshara capsule 500 mg TDS after meal and Ashmarihara kwatha 40 ml TDS after meal for 60 days |
| Comparator Agent |
Placebo Capsule with Water and Pathya Ahara |
In Group B, Placebo Capsule of 500 mg TDS with more than 2 liters of water and Pathya Ahara for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having age between 18 to 70 years
2) Stone size upto 10 mm
3) Patients of ashmari with controlled HTN and Diabetes Mellitus
4) Renal and Ureteric stone will be included
|
|
| ExclusionCriteria |
| Details |
1)Age below 18 years and above 70 years
2)Chronic Renal Failure
3)Gross Hydronephrosis
4)Acute Abdominal Pain
5)Cases which require Surgical Intervention
6)Severe Hematuria
7) Stone size more than 10 mm
8)Stone present in urinary bladder and urethera
9) Known cases of HIV, VDRL, Hepatitis, HTN ,Diabetes Mellitus,Cardiac disorders Malignancy ,TB |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Mootrashmari |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves quality of life of the person |
Improves quality of life of the person |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/01/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study comprises a Clinical Study to evaluate the effect of Palasha kshara and Ashmarihara kwatha in the management of Mootrashmari w.s.r. Urolithiasis. The pathogenesis of Mootrashmari involve one important factor i.e. Kapha dosha dusti . Kshara having bhedana property and Ashmarihara kwath containing bhedana drug will not only reduce the stone size but also will maintain the Renal function. But as per claim of some of the Urologists that stone size less than 10 mm is excreted out without any kind of medication , so in another group Placebo capsule and intake of plenty of water is advisable to patient . Thus this will not only validate the effetiveness of Ayurvedic drugs but will also prove its efficacy on Mootrashmari .
Procedure-
In one group, for 60 days Palasha kshara capsule ( 500 mg ) TDS , Ashmarihara kwatha 40 ml TDS and pathya ahara is advised and in another group Placebo capsule ( 500 mg ) TDS , drinking of more than 2 litres of water and pathya ahara is advised and result will be noticed after 60 days through X Ray (KUB) and USG ( W/A and pelvis).
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