| CTRI Number |
CTRI/2025/07/091489 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to see how effective Shigrumula kwath is in treating people with Kidney stones. |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of Shigrumula kwath in the management of Mutrashmari W.S.R. 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 Prerana Prakash Kaknale |
| Designation |
PG Scholer |
| Affiliation |
Yashwant Ayurvedic medical College, Kodoli, Tal- Panhala, Dist- Kolhapur |
| Address |
OPD No.4, Shalyatantra Department, Yashwant Ayurvedic medical college, Post graduation training and Research centre, Kodoli, Tal- Panhala, Dist- Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9145269101 |
| Fax |
|
| Email |
kaknaleprerana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi Maroti Narhare |
| Designation |
Professor at Shalyatantra Department |
| Affiliation |
Yashwant Ayurvedic medical College, Kodoli, Tal- Panhala, Dist- Kolhapur |
| Address |
OPD No.4, Shalyatantra Department, Yashwant Ayurvedic medical college, Post graduation training and Research centre, Kodoli, Tal- Panhala, Dist- Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822189226 |
| Fax |
|
| Email |
drlaxminarhare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Maroti Narhare |
| Designation |
Professor at Shalyatantra Department |
| Affiliation |
Yashwant Ayurvedic medical College, Kodoli, Tal- Panhala, Dist- Kolhapur |
| Address |
OPD No.4, Shalyatantra Department, Yashwant Ayurvedic medical college, Post graduation training and Research centre, Kodoli, Tal- Panhala, Dist- Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822189226 |
| Fax |
|
| Email |
drlaxminarhare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patients at Yashwant Ayurvedic medical college, Post graduation training and Research centre, Kodoli, Tal- Panhala, Dist- Kolhapur, Maharashtra, India
416114 |
|
|
Primary Sponsor
|
| Name |
Dr Prerana Prakash Kaknale |
| Address |
OPD No.4, Shalyatantra Department, Yashwant Ayurvedic medical college, Post graduation training and Research centre, Kodoli, Tal- Panhala, Dist- Kolhapur,
Maharashtra, India
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 Prerana Prakash Kaknale |
Yashwant Dharmarth Rugnalay , Kodoli |
OPD No.4, Shalyatantra Department, Yashwant Ayurvedic medical college, Post graduation training and Research centre, Kodoli, Tal- Panhala, Dist- Kolhapur,
Maharashtra, India
416114
Kolhapur
MAHARASHTRA |
09145269101
kaknaleprerana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic medical College, Post graduation training and Research centre, Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N20-N23||Urolithiasis. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shigrumul Kwath, Reference: Ashtang Hriday Mutraghat Chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Cap. Renali, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jal), 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 less than 6 mm.
2) The patient will be selected irrespective of gender, religion, occupation, marital status.
3) Patient with controlled DM and HTN.
|
|
| ExclusionCriteria |
| Details |
1) Patient of haematuria like bleeding disorders, glomerulonephritis, Nephropathy, drug induced haematuria etc.
2) K/C/O Uterine, Cervical, Vaginal, Urethral malignancy or any suspected malignancy, active genital herpes.
3) Patients having other disorders like STDs, Gout.
4) Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shigrumula Kwath is effective in the management of Mutrashmari. |
Initial assessment on 0th day.
Follow up on 10th, 20th, 30th day.
Final assessment on 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the effect of shigrumula kwath to reduce the sign and
symptoms of mutrashmari.
2) To study critical review of Urolithiasis.
3) To study the adverse effect, if any, of oral administration of Shigrumula
kwath.
4) To Achieve the result within 30 days.
5) To study the probable mode of action of Shigrumula kwath. |
Initial assessment on 0th day.
Follow up on 10th, 20th, 30th day.
Final assessment on 30th day. |
|
|
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)
|
21/08/2025 |
| 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="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 - NO
|
|
Brief Summary
|
This is Randomized open controlled clinical study to evaluate the efficacy of Shigrumula kwath in the management of Mutrashmri with special reference to Urolithiasis. This study will be done in the Shalyatantra OPD of Yashwant Ayurvedic Medical college, Kodoli Tal-Panhala, Dist-Kolhapur. This study will be carried out by comparing two groups. First Group (Trial Group) will be given Shigrumula kwath 40 ml BID before meal and Second Group (Control Group) will be given Cap. Renali 500 mg BID after meal. The result will be observed, and the conclusion will be drawn on the basis of observed values. |