| CTRI Number |
CTRI/2025/06/088668 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| 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
|
To Evaluate the Efficacy of Karkotaki Moola Churna in Mutrashmari With Special Reference To Urolithiasis |
|
Scientific Title of Study
|
A RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF KARKOTAKI MOOLA CHURNA IN THE MANAGEMENT OF MUTRASHMARI WITH SPECIAL REFERNECE 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 |
RAJKUNWAR VIJAYSINH DESHMUKH |
| Designation |
PG SCHOLAR |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 4 Shalya Tantra Department Yashwant Ayurvedic College Post Graduate and Research Centre Kodoli Kolhapur Maharashtra 416114 India
Kolhapur
Maharashtra
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9136392692 |
| Fax |
|
| Email |
rajkunwar.deshmukh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARDRA BHAGWATRAO THORAT |
| Designation |
PG GUIDE |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 4 Shalya Tantra Department Yashwant Ayurvedic College Post Graduate and Research Centre Kodoli Kolhapur Maharashtra 416114 India
Kolhapur
Maharashtra
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9970223088 |
| Fax |
|
| Email |
drardrathorat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJKUNWAR VIJAYSINH DESHMUKH |
| Designation |
PG SCHOLAR |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 4 Shalya Tantra Department Yashwant Ayurvedic College Post Graduate and Research Centre Kodoli Kolhapur Maharashtra 416114 India
Kolhapur
Maharashtra
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9136392692 |
| Fax |
|
| Email |
rajkunwar.deshmukh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College ,Post Graduate Training And Research Centre ,Kodoli ,Panhala District,Kolhapur-416114 |
|
|
Primary Sponsor
|
| Name |
Dr.Rajkunwar Vijaysinh Deshmukh |
| Address |
OPD NO 4 Shalya Tantra Department Yashwant Ayurvedic College Post Graduate and Research Centre Kodoli Kolhapur Maharashtra 416114 India |
| 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 |
| DrRajkunwar Vijaysinh Deshmukh |
Yashwant Dharmartha Rugnalaya, Kodoli |
Opd No 4 Shalya Tantra Department 2nd Floor Yashwant Ayurvedic College Post Graduate Training and Research Center,Kodoli Kolhapur
Kolhapur
MAHARASHTRA |
9136392692
rajkunwar.deshmukh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KARKOTAKI MOOLA CHURNA, Reference: GADANIGRAHA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: GODUGDHA), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: TAB CYSTONE, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: GODUGDHA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1]Patient with clinical features and USG showing ureteric,kidney ,bladder calculus of size from 2mm to 8mm single or multiple or bilateral calculus will be taken for treatment
2]Patient with normal KFT
3]Patient with controlled DM and HTN
4]Patients presenting with below mentioned signs and symptoms of Ashmari
- Regional pain[Nabhi,Basti,Sevani,Mehana Vedana]
- Burning Micturation [Sadaha Mutrapravrutti]
- Onstruction of Urine flow [Mutradharsanga] |
|
| ExclusionCriteria |
| Details |
1]Patients with grade3 and grade 4 Hydronephrosis referring to USG
2] Patient with known malignanacies,thyroid disorders,UTI
3] Pregnant and Lactating Mother
4]Case which requires any other surgical intervention
5]Acute and Chronic urine retention, Pyelonephritis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Efficacy Of Karkotaki Moola Churna in Mutrashmari With Special Reference to Urolithiasis |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1]To find out whether this drug reduces the size of Mutrashmari or promotes its expulsion
2] To study the probable mode of action of Karkotaki Moola Churna
3] To study the disease Mutrashmari according to Ayurvedic science and Modern science |
10 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)
|
03/07/2025 |
| 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 23-06-2025 and end date provided 15-07-2029?
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
|
This study is Open Randomized Controlled Clinical Study to Evaluate The Efficacy of Karkotaki Moola Churna In Mutrashmari With Special Reference To Urolithiasis. This study will be carried out in OPD of Shalyatantra department of Yashwant Ayurvedic College and hospital Kodoli Observation will be drawn on the basis of symptoms after treatment given. |