| CTRI Number |
CTRI/2020/09/027885 [Registered on: 18/09/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| 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
|
Treatment of Renal Stone with an Ayurvedic Drug (Kadali Kshara) |
|
Scientific Title of Study
|
Efficacy of Kadali Kshara in Different Doses in the Management of Mootrashmari w s r to Urolithiasis A Randomised Double Blind 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 |
kirthi A |
| Designation |
MS PG Scholar |
| Affiliation |
KLE Shri BMK Ayurved Mahavidyalaya Belagavi |
| Address |
Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurveda Hospital and Medical Research Centre Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
8296086928 |
| Fax |
|
| Email |
manasumouna24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmikant |
| Designation |
Professor |
| Affiliation |
KLE Shri BMK Ayurved Mahavidyalaya Belagavi |
| Address |
c/o Shalya tantra Dept
Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurveda Hospital and Medical Research Centre Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9480007651 |
| Fax |
|
| Email |
shalyalsd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kirthi A |
| Designation |
MS PG Scholar |
| Affiliation |
KLE Shri BMK Ayurved Mahavidyalaya Belagavi |
| Address |
Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurveda Hospital and Medical Research Centre Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
8296086928 |
| Fax |
|
| Email |
manasumouna24@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Pharmacy Khasbag Belagavi Karnataka 590003 |
|
|
Primary Sponsor
|
| Name |
KLE UNIVERSITY |
| Address |
Shri B M Kankanawadi Ayurved Mahavidyalaya shahapur Belagavi Karnataka 590003 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Kirthi A |
KLE Ayurveda Hospital and Medical Research Centre |
Shahapur Belagavi
Belgaum
KARNATAKA |
8296086928
manasumouna24@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: N22||Calculus of urinary tract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kadali Kshara 250 mg |
Dose one capsule
Frequency twice daily
Duration 28 days
Route Of administration orally |
| Comparator Agent |
Kadali Kshara 500 mg |
Dose one capsule
Frequency twice daily
Duration 28 days
Route of Administration orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Non obstructive urolithiasis |
|
| ExclusionCriteria |
| Details |
Patients having any history of HTN DM BPH Ca of Prostate Hydronephrosis Renal failure HbSAg HIV 1 2 Any systemic disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| size of stone |
7th day, 14th day and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| How much size of stone reduced |
28th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
to investigate the dose dependent effect of kadali kshara in mutrashmari wsr to urolithiasis to compare the effect of kadali kshara 250mg bd and 500mg bd in mutrashmari wsr to urolithiasis against standard drug |