| CTRI Number |
CTRI/2024/06/068903 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see the effect of Tilanala Kshaara in the management of kidney stones over Trikantaka beeja churna |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Efficacy of Trikantaka Beeja Churna Over Tilanala Kshara in the Management of Mutrashmari with Special Reference to Urolithiasis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KORE AMASIDHA LAXMAN |
| Designation |
2ND YEAR PG SCHOLAR |
| Affiliation |
BLDE ASSOCIATIONS AVS AYURVEDA MAHAVIDYALAYA HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPT OF PG STUDIES SHALYATANTRA
BLDEAS AVS AMV HOSPITAL AND RESEARCH CENTER, VIJAYAPUR,BAGALKOT ROAD, VIDHYANAGARA, VIJAYAPURA
Bijapur
KARNATAKA
586109
India |
| Phone |
9590197678 |
| Fax |
|
| Email |
ammukore12@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRASADSHAKTI GANNUR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
BLDE ASSOCIATIONS AVS AYURVEDA MAHAVIDYALAYA HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPT OF PG STUDIES IN SHALYATANTRA
BLDEAS AVS AMV HOSPITAL AND RESEARCH CENTER, VIJAYAPUR,BAGALKOT ROAD, VIDHYANAGARA, VIJAYAPURA
Bijapur
KARNATAKA
586109
India |
| Phone |
9480062140 |
| Fax |
|
| Email |
pgannur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRASADSHAKTI GANNUR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
BLDE ASSOCIATIONS AVS AYURVEDA MAHAVIDYALAYA HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPT OF PG STUDIES IN SHALYATANTRA
BLDEAS AVS AMV HOSPITAL AND RESEARCH CENTER, VIJAYAPURA,BAGALKOT ROAD, VIDHYANAGARA, VIJAYAPURA
KARNATAKA
586109
India |
| Phone |
9480062140 |
| Fax |
|
| Email |
pgannur@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research Centre Vijayapura, Bagalkot road, Vidhyanagara, Vijayapura, 586109 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| DR KORE AMASIDHA LAXMAN |
BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research centre, Vijayapura 586109 |
OPD NO 03,
Dept. of Shalyatantra
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vijayapura, Bahalkot road, Vidyanagara, Vijayapura 586109
Bijapur
KARNATAKA |
9590197678
ammukore12@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BLDEA AVS Ayurveda Mahavidyalaya Hospital and research Centre |
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. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tilanala Kshara , Reference: Yogaratnakara, Ashmari chikitsa, shloka no 44, Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Goksheera and Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trikantaka beeja churna , Reference: Chakradatta, Ashmari chikitsa, shloka no 34, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Aviksheera and Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fufiling diagnostic criteria
Presence of calculi from 4mm to 8mm size, confirmed by USG either unilaterally or bilaterally
Patients with solitary or multiple calculi
Pain with or without haematuria
Pain with or without dysuria |
|
| ExclusionCriteria |
| Details |
Patients with renal calculi and complications like severe hydronephrosis, glomerular nephritis and chronic renal failure
Patients with other systemic disorders like Diabetes, HTN, TB, HIV, hepatitis B, Veneral diseases and renal carcinoma
Pregnant women and lactating mother
Paneeya kshara anarha patients
Staghorn calculi |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the size of calculi
Expulsion of the calculi |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subsiding of other symptoms |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is comparative
clinical study to evaluate the efficacy of tilanala kshara kshaara over
trikantaka beeja churna in the management of mutrashmari, as kidney stones are
very common in the present generation and produces more pain which is untolerable.
Modern medicines are very costly to purchase for poor persons so the present
study drug will be of low cost so everyone can afford and the drug is having
ksharana and lekhana property it helps
to prevent the renal calculi so, this study will be conducted in BLDEAs AVS Ayurveda
Mahavidyalaya, Hospital and Research Centre, Vijayapura 586109 Karnataka ,
India |