| CTRI Number |
CTRI/2025/11/097994 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see the effect of eradadi kalk in the management of mutrashmari with special reference to urolithiasis |
|
Scientific Title of Study
|
RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE
EFFICACY OF ERANDADI KALKA 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 Piyush Sarang Ubale |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre kodoli |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic College Post
Graduate Training and Research Center, Tal Panhala, Dist Kolhapur
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic College Post
Graduate Training and Research Center, Tal Panhala, Dist Kolhapur
Kolhapur
MAHARASHTRA
4161114
India |
| Phone |
9168488743 |
| Fax |
|
| Email |
ubalepiyush0811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivas Narsimha Turlapati |
| Designation |
PG Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic College Post
Graduate Training and Research Center, Tal Panhala, Dist Kolhapur
Kolhapur
MAHARASHTRA
4161114
India |
| Phone |
9503147698 |
| Fax |
|
| Email |
drsrinivast@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivas Narsimha Turlapati |
| Designation |
PG Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic College Post
Graduate Training and Research Center, Tal Panhala, Dist Kolhapur
Kolhapur
MAHARASHTRA
4161114
India |
| Phone |
9503147698 |
| Fax |
|
| Email |
drsrinivast@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD, IPD And Casualty Patients Yashwant Ayurvedic Medical college kodoli kolhapur 416414
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Piyush Sarang Ubale |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic College Post
Graduate Training and Research Center, Tal Panhala, Dist Kolhapur |
| Type of Sponsor |
Other [Self] |
|
|
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 Piyush Ubale |
Yashwant Dharmarth Rugnalay Kodoli |
OPD No 4 Shalyatantra department
2nd floor Yashwant Ayurvedic College
Post Graduate Training and Research Centre
Kolhapur
MAHARASHTRA |
9168488743
ubalepiyush0811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT& RC Kodoli |
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: ASMARIJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erandadi kalka, Reference: YOGARATNAKARA part02 chapter 38 Diagnosis and Treatment Of Urolithiasis verse no 32, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: - madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tab cystone, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Predignosed patient with clinical features and USG showing calculus
of size upto 8 mm single or multiple will be taken for treatment.
Calculus presents in kidney ureter bladder uni or B L
Subjects of the age in between 20 60 years
The patient will be irrespective of religion gender occupation marital status
Know case of Controlled Diabetes and HTN |
|
| ExclusionCriteria |
| Details |
Calculus more than 8mm in size. Patients of shukrashmari. Impacted calculi patient having Renal failure. Case which requird surgical intervention
Know case of Tuberculosis etc
Urine retention acute or chronic. Severe hydronephrosis hydroureter
Pyelonephritis
Increased RFT valuesHypo hyperthyroidism
Gout
BPH
HIV HbsAg uncontrolled Diabetes Mellitus HTN
Any malignancy
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
STUDY THE EFFICACY OF ERANDADI KALKA IN THE MANAGEMENT OF MUTRASHMARI
WITH SPECIAL REFERENCE TO UROLITHIASIS. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To assess improvement by sign, prognosis and gradation of assessment criteria
2)To reduce discomfort and complaints of patients
3)To achieve outcome in 15 days |
15 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
05/12/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 25-03-2025 and end date provided 13-04-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ERANDADI KALKA IN THE MANAGEMENT OF MUTRASHMARI WITH SPECIAL REFERENCE TO UROLITHIASIS. Assessment of sign and symptoms will be done on follow up days and outcome will be assessed after 15 days |