CTRI Number |
CTRI/2023/05/053091 [Registered on: 24/05/2023] Trial Registered Prospectively |
Last Modified On: |
23/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
An open labelled randomised comparative clinical and in vitro study to evaluate the effect of Pashanabhedadi kashaya ghana capsule and Pashanabheda kashaya ghana capsule in the management of Mootrashmari vis-Ã -vis Nephrolithiasis |
Scientific Title of Study
|
An open labelled randomised comparative clinical and invitro study to evaluate the effect of Pashanabhedadi kashaya ghana capsule and Pashanabheda kashaya ghana capsule in the management of Mootrashmari vis-Ã -vis Nephrolithiasis |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr SHAILESH Y |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
SDMCA KUTHPADY UDUPI, KARNATAKA |
Address |
PG AND PhD STUDIES IN THE DEPARTMENT OF KAYACHIKITSA
SDMCA Kuthpady, Udupi, Karnataka
574118 NEJAR NEAR ASHWATHKATTE
POST SANTHEKATTE
UDUPI, KARNATAKA 576105 Udupi KARNATAKA 574118 India |
Phone |
9481522560 |
Fax |
|
Email |
drshayayu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr SHRILATHA KAMATH T |
Designation |
PROFESSOR AND HEAD |
Affiliation |
SDMCA KUTHPADY UDUPI, KARNATAKA |
Address |
PG AND PhD STUDIES IN THE DEPARTMENT OF KAYACHIKITSA
SDMCA Kuthpady, Udupi, Karnataka
Udupi KARNATAKA 574118 India |
Phone |
9964899638 |
Fax |
|
Email |
shri9503@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr SHAILESH Y |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
SDMCA KUTHPADY UDUPI, KARNATAKA |
Address |
PG AND PhD STUDIES IN THE DEPARTMENT OF KAYACHIKITSA
SDMCA Kuthpady, Udupi, Karnataka
NEJAR NEAR ASHWATHKATTE
POST SANTHEKATTE
UDUPI KARNATAKA 574105 Udupi KARNATAKA 574118 India |
Phone |
9481522560 |
Fax |
|
Email |
drshayayu@gmail.com |
|
Source of Monetary or Material Support
|
SDM AYURVEDA PHARMACY KUTHPADY UDUPI KARNATAKA |
|
Primary Sponsor
|
Name |
NIL |
Address |
NIL |
Type of Sponsor |
Other [SELF FUNDED] |
|
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 SHAILESH Y |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA KUTHPADY UDUPI KARNATAKA |
PG AND PhD STUDIES IN THE DEPARTMENT OF KAYACHIKITSA
KUTHPADY UDUPI KARNATAKA 574118 Udupi KARNATAKA |
08202520332
drshayayu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE HUMAN |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PASHANABHEDA KASHAYA GHANA CAPSULE, Reference: SHARANGHADHARA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: PASHANABHEDA GHANA KASHAYA FILLED TO VEG CAPSULE EACH CAPSULES CONTAIN 4GRMS OF GHANA KASHAYA | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: PASHANABHEDADI KASHAYA GHNA CAPSULE, Reference: YOGARATNAKARA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: PASHANABHEDADI KASHAYA GHANA FILLED IN VEG CAPSULES. EACH CAPSULES CONTAINS 4GMS OF GHANA KASHAYA |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Diagnosed cases of Mootrashmari vis-Ã -vis Nephrolithiasis as per the diagnostic criteria
Patients with solitary or multiple renal calculi with size less than or equal to 10 mile meter size
Participants are willing to provide informed consent
|
|
ExclusionCriteria |
Details |
Patients with associated obstructive pathologies like BPH urethral stricture and congenital anatomical abnormalities
Renal calculi in associated with uretreric bladder or uretral calculi
During the phase of Renal colic and Ureteric colic
Patients with severe Hydronephrosis
Pregnant women and lactating mothers
Systemic diseases which interfere with disease process and present clinical trial
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
EXPULTION OF KIDNEY STONES |
AT 45TH DAY |
|
Secondary Outcome
|
Outcome |
TimePoints |
IMPROVEMENT OF QUALITY OF LIFE
based on a questionnaire |
AT 45TH DAY |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/06/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
01/06/2023 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="5" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NONE YET |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Background of the study: Nephrolithiasis or calculi formation in kidneys, is a common problem worldwide, with prevalence of 7% in the adults and > 30% recurrence rate within 10years. The incidence of Nephrolithiasis is globally increasing with an estimated prevalence ranging up to 15%. During lifetime, approximately 7% of women and 13% of men will develop a kidney stone. In Indian population, about 12% of them are expected to have urinary stones and out of which 50% may end up loss of kidney functions. Invasive therapies for removal of calculi such as ESWL ( Extra corporeal shock wave Lithotripsy). PCNL (Percutaneous nephrolithotripsy), Basketing therapy, Pylolithotomy are commonly for the management of Nephrolithiasis . Features of Nephrolithiasis are closely similar to the disease Mootrashmari in the Ayurveda parlance and majority of the pathology in both the condition are similar. Purpose of the study: In spite of technological advances in the field of medicine and surgery conservative therapy still continues to a solution for all reversible ailments. Even though invasive therapies are one of the alternatives used commonly for the management of Nephrolithiasis , however these therapies have their own disadvantages and complications. Kshara, kashaya and churna yogas are frequently used forms of medicines, palatability is major challenges. Considering the magnitude of the condition at present, there is a need of widely acceptable, evidence based, cost effective, easily available, simple, safe and single drug for Nephrolithiasis. |