| CTRI Number |
CTRI/2026/01/100210 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
See the effect of Trikantakadi kwath and Trunpanchmul kwath in management of pittaj mutrakruchha(Urinary tract infection). |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Study to evaluate the efficacy of Trikantakadi Kwath in the management of Pittaj Mutrakruchha w.s.r.to Urinary 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 |
Dr Nirali Ganesh Nimodiya |
| Designation |
MD kayachikitsa scholar |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya patur akola |
| Address |
OPD No.3 , Department of Kayachikitsa, Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir Patur Akola
Maharashtra,India
Akola MAHARASHTRA 444501 India |
| Phone |
7972866880 |
| Fax |
|
| Email |
nirali2601200@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jayshree katole |
| Designation |
Professor and Head of the department, kayachikitsa |
| Affiliation |
Dr VJD Gramin ayurved mahavidyalaya |
| Address |
OPD NO 3 Department of Kayachikitsa, Dr VJD Gramin Ayurved Mahavidyalaya, near Renuka mata mandir, Patur, Tal-Patur, Dist-Akola Pin-444501 MAHARASHTRA INDIA
Akola MAHARASHTRA 444501 India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jayshree katole |
| Designation |
Professor and Head of the department, kayachikitsa |
| Affiliation |
Dr VJD Gramin ayurved mahavidyalya |
| Address |
OPD NO 3 Department of Kayachikitsa, Dr VJD Gramin Ayurved Mahavidyalaya, near Renuka mata mandir, Patur, Tal-Patur, Dist-Akola Pin-444501 MAHARASHTRA INDIA
Akola MAHARASHTRA 444501 India |
| Phone |
942387608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.VJD Gramin Ayurved Mahavidyalaya, near Renuka mata mandir, Patur, Tal-Patur, Dist-Akola, Maharashtra, India Pin-444501 |
|
|
Primary Sponsor
|
| Name |
Dr .VJD Gramin Ayurved Mahavidyalaya,patur |
| Address |
Dr.VJD Gramin Ayurved Mahavidyalaya, near Renuka mata mandir, Patur, Tal-Patur, Dist-Akola, Maharashtra, India Pin-444501 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nirali Ganesh Nimodiya |
Dr VJD Gramin Ayurved Mahavidyalaya |
OPD No. 3 ,Department of Kayachikitsa Dr VJD Gramin Ayurveda Mahavidyalaya, near Renuka Mata mandir, Patur, Tal Patur,Dist Akola
Akola MAHARASHTRA |
7972866880
nirali2601200@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Dr VJD Gramin ayurved mahavidyalaya patur |
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: PITTAJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trikantakadi kwath, Reference: Bhaisajya ratnawali , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: koshnajal ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trunpanchamul kwath , Reference: Bhaisajya Ratnawali , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 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 |
1. Patients willing for clinical trial.
2. Patient having the sign and symptom of Pittaj mutrakruccha.
3. The patients of age group 18 to 60 years will be selected.
4. The patients will be selected irrespective of sex & religion. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing for clinical trial.
2. Age less than 18 years and more than 60 years.
3. Severe traumatic cases.
4. Any severe deformity..
5. Pregnant woman, lactating mothers.
6. Any other major illness like HIV, AIDS, TB, HTN, DM and any malignancy.
7. Pateint presenting symptoms due to obstructed pathology like BPH, Renal calculi, vesical calculus cystitis,intersitial cystitis.phimosis.paraphimosis and pelvic inflammatory diseases.
8. Chronicity above 1 year. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.peet mutrata 2.sarakta mutrata 3.saruja mutrata 4.sadaha Mutrata 5.kruchra mutrata 6.Muhurmuhu mutrata symptoms will be decreased |
After 3 days ,8 days and 15 days from starting of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased symptoms completely |
18 months |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
15/01/2026 |
| 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="1" |
|
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
|
The word "Ayurveda" in which Ayu means Life and Veda means Knowledge. Therefore Ayurveda means Knowledge of Life. Means to maintain the health of healthy one and cure the disease of Diseased one. Hence Ayurveda is sometimes also called as the preventive Science. Thus both prophylaxis and cure are dealt in this science. Everything Which is necessary for the good health has been explained in ayurveda.
Among Trimala, Mutra is responsible for bastipoorana and kleda vahanam. When. this physiology i hampered it leads to Mutravaha strotoas Dushti Vikaras. When person indulges in Nidana sevana like intake of Ati Ruksha, Ushna, Tikshana Ahara, Mutravegadharana, Ati vyavaya leads to diseases of Mutravahasrotodushti vikars. In today’s era the above nidanas are commonly observed due to working pattern or busy schedule or lifestyle of person and indulging in such type of etiology causes vitiation of all three doshas which accumulates in urinary system and does the vitiation of mutra and causes pittaja mutrakrichhra.
Mutrakruchha is a broad term, which covers the conditions Medical Science as Urinary Tract Infection (UTI). The Pratyatma lakshana of Mutrakruchha is Dukhena Mutra pravutti", means discomfort during Micturition. In pittaj Mutrakruchha the vitated pitta dosha along with vata(Mainly Aapana vayu)onreaching basti affects the mutravaha strotas. Urinary tract infections such
as abnormal colour of urine can be compared with Sarakta/Sapeeta Mutrata, burning sensation while micturation can be compared with Sadaha Mutrapravrutti and pain while micturation can be compared with Krucchra Mutrapravrutti, Frequency and urgency can be compared with Muhurmuhu Mutrapravrutti and suprapubic can be compared with saruja/kruchra mutrata.
Urinary tract infections are second in frequency after upper respira infections. Escheria coli is the most common uropathogen identifis studies Medical Science as Urinary Tract Infection (UTI). Most of are the population from rural area exposed to sunrays, having improper intake of water and Food & which leads to dehydration condition and acidic urine leading to urinary tract infection.
In Urban areas. People have to travel far away for work, daily busy Routine, less water intake, fond of Junk food, Fast Food, holding of Natural urge like urination for long period and use of public toilets frequently and unhygienic practices all this leads to urinary tract infection
Urinary Tract infections are second in frequency after respiratory tract infections, Incidence and degree of morbidity and mortality from infections are greater with those in the urinary tract than with those of the upper respiratory tract. Bacteria are by far the most common invading organisms but fungi, yeasts and viruses also produce urinary tract infections. Thus, urinary tract infection is potentially a serious condition and failure to realize that this may lead to development of serious chronic pyelonephritis and chronic renal failure. With the introduction of effective antibiotics problem has been solved to some extent but the use of, antibiotics have limitations like side effects, chances of reinfection and. relapse even after long-term therapy. Simultaneously increasing incidence of resistance and high cost of therapy are common problems.
Ayurveda offers alternative therapies like Trikantakadi kwath, and Trunpanchmuladi kwath which are believed to have properties such as Pittashamaka (Pitta pacifying) Mutral and anti-microbial effects, making them potential treatments for pittaj Mutrakruchha. |