| CTRI Number |
CTRI/2025/04/084999 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| 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 Katak Beej Churna in Mutrashamri With Special Reference To Urolithiasis |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Study To Evaluate The Efficacy Of Katak Beej Churna In 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 |
AVINASH CHANDRAKANT KHADE |
| 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 |
| Phone |
8329471056 |
| Fax |
|
| Email |
avikhade111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNarhare Laxmi Maroti |
| Designation |
Associate Professor |
| 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 |
| Phone |
9822189226 |
| Fax |
|
| Email |
drlaxminarhare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AVINASH CHANDRAKANT KHADE |
| 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 |
| Phone |
8329471056 |
| Fax |
|
| Email |
avikhade111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College,Post Graduate Training And Research Center Kodoli Tq Panahla Dist Kolhapur -416114 |
|
|
Primary Sponsor
|
| Name |
Dr.Avinash Chandrakant Khade |
| Address |
OPD NO4 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 |
| Dr Avinash Chandrakant Khade |
Yashwant Dharmartha Rugnalaya, Kodoli |
Opd no 4 Shalyatantra
department 2nd floor
Yashwant Ayurvedic College
Post Graduate Training and
Research Center, Kodoli
Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA |
8329471056
avikhade111@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 | 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: 21 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Katakbeej churna, Reference: Dhanwantari Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients showing symptom according to ayurveda types
Vatajashmari
Pittajashmari
Kaphajashmari
1) Patient irrespective of gender
2)Subjects of the age in between 18 - 60 years.
3) Predignosed patient with clinical features and USG showing calculus of size
upto 6 mm single or multiple will be taken for treatment.
4) Calculus presents in kidney / ureter/bladder uni or B/L
|
|
| ExclusionCriteria |
| Details |
1)Calculus more than 6mm in size.
2)Patients of shukrashmari.
3)patient having k/c/o Renal failure.
4)Case which required surgical interventio
5) K/C/O HIV, HbsAg,Diabetes Mellitus
,HTN, Tuberculosis,etc
6)Urine retention:- acute or chronic.
7)Severe hydronephrosis, hydroureter
8)Pyelonephritis
9) K/c/o Hypothyroidism, Gout,BPH
10) Any malignancy
11) Pregnant and lactating women |
|
|
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 Katakbeejchurna In Mutrashmari With Special Reference to Urolithiasis
|
21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the probable mode of action of Katakbeejchurna
2)To find out whether this drug reduces the size and number of Mutrashmarior
promotes its expulsion.
3)To study the disease mutrashmari according to Ayurvedic science and Modern science |
21days |
|
|
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)
|
28/04/2025 |
| 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="0"
Months="1"
Days="6" |
|
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 open randomized controlled clinical trial study to evaluate the efficacy of Katakbeej churna in Mutrashmari with special refrence to Urolithiasis. This study will be carry in OPD of Shalyatantra department of Yashwant Ayurvedic College and hospital kodoli. Observation would be drawn on the basis of symptoms after treatment given.
|