| CTRI Number |
CTRI/2025/08/092461 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| 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
|
Studying the Effect of Shwadanshtradi Kwath (an Ayurvedic Herbal Medicine) on Kidney Stones |
|
Scientific Title of Study
|
RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE
EFFICACY OF SHWADANSHTRADI KWATH 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 |
Dr Hrishikesh Subhash Patil |
| 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 |
7774819210 |
| Fax |
|
| Email |
hrishipatil802.hp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivas Turlapati |
| Designation |
HOD |
| 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 |
9503147698 |
| Fax |
|
| Email |
drsrinivast@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivas Turlapati |
| Designation |
HOD |
| 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 |
9503147698 |
| Fax |
|
| Email |
drsrinivast@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 Hrishikesh Subhash Patil |
| Address |
OPD no 4 shalyatantra dept Yashwant Ayurvedic College Post
Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist Kolhapur
416114
|
| 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 Hrishikesh Subhash Patil |
Yashwant Dharmartha Rugnalaya, kodoli |
OPD NO 4 Shalya Tantra Department Yashwant Ayurvedic College post graduate and
Research Centre kodoli Kolhapur Maharashtra 416114 India
Kolhapur
MAHARASHTRA |
07774819210
hrishipatil802.hp@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: 15 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shwadanshtradi kwath, Reference: Bhaishaj Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
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 Shwadanshtradi kwath In Mutrashmari With Special Reference to
Urolithiasis |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To find out whether Shwadanshtradi kwath reduces the size of
Mutrashmari or promotes its expulsion.
2) To find out whether Shwadanshtradi kwath reduces the numbers of
ashmari. |
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="4"
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 open randomised controlled clinical trial study to evaluate the efficacy of Shwadanshtradi kwath in mutrashmari with special reference to urolithiasis. This study will be carry in OPD of shalytantra department of Yashwant ayurvedic college and hospital kodoli. Observation would be drawn on the basis of symptoms after treatment given. |