| CTRI Number |
CTRI/2025/05/086156 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Medicated kashaya for pittaja mutrakrichra(urinary tract infection). |
|
Scientific Title of Study
|
A Randomised controlled clinical study of Kallurvanjyadi Kashaya in the management of Pittaja Mutrakrichra. |
| 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 Akash R Terdal |
| Designation |
PG SCHOLAR |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
DEPT OF P.G STUDIES KAYACHIKITSA 3RD FLOOR Alvas Ayurveda Medical college and hospital Vidyagiri Moodbidiri D.K
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8884483149 |
| Fax |
|
| Email |
terdalakash52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susheel Shetty |
| Designation |
PROFESSOR and HOD |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
DEPT OF P.G STUDIES KAYACHIKITSA 3RD FLOOR Alvas Ayurveda Medical college and hospital Vidyagiri Moodbidiri D.K
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9980431676 |
| Fax |
|
| Email |
shettysusheel13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash R Terdal |
| Designation |
PG SCHOLAR |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
DEPT OF P.G STUDIES KAYACHIKITSA 3RD FLOOR Alvas Ayurveda Medical college and hospital Vidyagiri Moodbidiri D.K
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8884483149 |
| Fax |
|
| Email |
terdalakash52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical college and hospital vidyagiri Moodbidri D.K Karnataka 574227 |
|
|
Primary Sponsor
|
| Name |
Dr.Akash R Terdal |
| Address |
DEPT OF P.G STUDIES KAYACHIKITSA 3RD FLOOR Alvas Ayurveda Medical college and hospital Vidyagiri Moodbidiri D.K |
| 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 Akash R Terdal |
Alvas Ayurveda medical college and hospital,Moodbidri |
DEPT OF P.G STUDIES KAYACHIKITSA 3RD FLOOR Alvas Ayurveda Medical college and hospital Vidyagiri Moodbidiri D.K
Dakshina Kannada
KARNATAKA |
08884483149
terdalakash52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee alvas ayurveda medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Kwatha, Reference: Cakradatta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kallurvanjyadi kashaya , Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will fulfill the diagnostic criteria.
Patients with age group between 18 to 60 years (Both age inclusive).
Patients who are willing to enroll in the research and sign the consent form.
|
|
| ExclusionCriteria |
| Details |
•Pittaja mutrakrichra due to bastimarmabhighata.
•Patients having STD
•Patient with Congenital Deformity
•Secondary to a disorder like Renal Calculi, BPH, Acute Renal Failure, Diabetes mellitus, vesico-ureteric reflux, malignancy related to genitourinary tract, Renal Tuberculosis.
•Pregnant and Lactating women will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Kallurvanjyadi Kashaya in the management of Pittaja Mutrakrichra.
|
15 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
objective parameter assessed
Pus Cells / hpf
Epithelial Cells /hpf
RBC’s / hpf
|
on 14th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/05/2025 |
| 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="0"
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
|
This research protocol aims to compare the therapeutic effectiveness of Kallurvanjyadi Kashaya and Haritakyadi Kwatha in managing Pittaja Mutrakrichra an Ayurvedic condition characterized by difficult micturition and symptoms resembling Lower Urinary Tract Infection (UTI). The study will be a randomized controlled clinical trial involving 40 patients divided into two groups each receiving one of the two Kashayas for seven days. Subjective parameters like burning micturition, painful micturition, and frequency along with objective urine analysis parameters (pus cells, epithelial cells, RBCs) will be assessed at baseline, day 8 and day 14. The study seeks to evaluate if Kallurvanjyadi Kashaya is more effective than the standard Haritakyadi Kwatha in alleviating the symptoms of Pittaja Mutrakrichra. |