| CTRI Number |
CTRI/2025/07/090687 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Shunthyadi Kwath Ghanavati in mutraj vikar |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Shunthyadi Kwath Ghanavati in mutrakruchhra w.s.r.t.urinari tract infection. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manoj Vasant Ghadawaje |
| Designation |
PG Scholar Shalyatantra Dept. |
| Affiliation |
ASS Ayurved Mahavidyalaya Nashik |
| Address |
OPD no 6 Arogyashala Rugnalaya Ganeshwadi Nashik 422003
OPD no 6 Arogyashala Rugnalaya Ganeshwadi Nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8805362089 |
| Fax |
|
| Email |
drmanoj_g@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Pathak |
| Designation |
MS Shalyatantra |
| Affiliation |
ASS Ayurved Mahavidyalaya Nashik |
| Address |
Arogyashala Rugnalaya Ganeshwadi Panchavati Nashik 422003
Arogyashala Rugnalaya Ganeshwadi Panchavati Nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9405369727 |
| Fax |
|
| Email |
drsantoshsp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Vasant Ghadawaje |
| Designation |
PG Scholar Shalyatantra Dept. |
| Affiliation |
ASS Ayurved Mahavidyalaya Nashik |
| Address |
Arogyashala Rugnalaya Ganeshwadi Nashik 422003
Arogyashala Rugnalaya Ganeshwadi Nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8805362089 |
| Fax |
|
| Email |
drmanoj_g@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Manoj Vasant Ghadawaje |
| Address |
Ayurved Mahavidyalaya Panchvati Ganeshwadi Nashik 422003 |
| 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 Manoj Vasant Ghadawaje |
Arogyashala Rugnalaya Ganeshwadi Nashik |
OPD no 6 Arogyashala Rugnalaya Ganeshwadi Nashik 422003
Nashik
MAHARASHTRA |
8805362089
drmanoj_g@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurved Seva Sangh Ayurved Mahavidyalaya,Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N341||Nonspecific urethritis. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi Kwath Ghanavati , Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: - Jal), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | NORFLOXACINE | ANTIBIOTIC IN URINARY TRACT INFECTION |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pateints diagnosed with UTI with pus cells in urine microscopy and sa-shul,sa-dah and muhurmuhur mutrapravrutti |
|
| ExclusionCriteria |
| Details |
Non willing to participate,patientson haemodialysis,organ transplant,prostate ca,urinary tract malignancy,uncontrolled diabetes mellitus,pyelonephrosis,tuberculosis stricture,structural deformity of urinary system,pelvic trauma,bladder dysfunction,neurogenic bladder.Also patients with urine microscopy pus cells more than 30/hpf |
|
|
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 |
| reduction in symptoms like burning and pain during micturition.Reduction in urethral swelling . |
15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in murmuhur mutrapravrutti,pus cells and RBC decreased in urine microscopy |
2 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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 Yet Recruiting |
| 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
|
|