| CTRI Number |
CTRI/2026/02/105078 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Trinpanchmooladi Ghrita Uttarbasti and Mutradahaantak Churna effect in the Pittaj Mutrakrichhra (Urinary Tract Infection) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Trinpanchmooladi Ghrita Uttarbasti and Mutradahaantak Churna in the Management of Pittaj Mutrakrichhra 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 |
Prof Anil Bhardwaj |
| Designation |
Professor and Head |
| Affiliation |
Rajiv Gandhi Government.Post Graduate College and Hospital Paprola District Kangra Himachal Pradesh |
| Address |
Room no.203 PG Department of Panchkarma RGGPGACH Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418466766 |
| Fax |
|
| Email |
anil5karma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anil Bhardwaj |
| Designation |
Professor and Head |
| Affiliation |
Rajiv Gandhi Government.Post Graduate College and Hospital Paprola District Kangra Himachal Pradesh |
| Address |
Room no.203 PG Department of Panchkarma RGGPGACH Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418466766 |
| Fax |
|
| Email |
anil5karma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneh Rathore |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government.Post Graduate College and Hospital Paprola District Kangra Himachal Pradesh |
| Address |
Room no.701 PG Department of Panchkarma RGGPGACH Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018387925 |
| Fax |
|
| Email |
snehrathore85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy Paprola District Kangra HP Charak Pharmacy Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola District Kangra HP Research institute in ISM Jogindernagar District Mandi Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic college |
| Address |
RGGPG Ayurvedic College and Hospital kangra 176115 |
| 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 |
| Prof Anil Bhardwaj |
Rajiv Gandhi Government Post graduate Ayurvedic College and Hospital Paprola |
Room No. 203 Department of Panchkarma Rajiv Gandhi Government Post graduate Ayurvedic College and Hospital Paprola District Kangra HP
Kangra
HIMACHAL PRADESH |
9418466766
anil5karma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee (Human) Rajiv Gandhi Govt.Post Graduate college and Hospital Paprola Distt.kangra H.P.176115 India |
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 (Non Ayurveda) | | - | Nitrofurantoin | Nitrofurantoin 100mg BD after meal orally for 7 days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: mutradahaantak churana, Reference: Rasatantrasaar Va sidhprayoga sangraha (part2)page -378-379, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -chandanaadi Arka ), Additional Information: -chandanaadi arka 20ml TID
refernce sidh prayog sangrah page no.3 | | 3 | Intervention Arm | Procedure | - | uttara-basti, उत्तर-बस्तिः | (Procedure Reference: sushruta uttar 29/20,21, Procedure details: Purva karma-collection of material,vital monitoring Pradhan karma-micuration before procedure, postioning of patient,insertion of Foleys catheter ,pushing of medicine into bladder,removal of Foleys catheter,rest for 15 min.
Paschat karma- vital monitoring,light food intake )
(1) Medicine Name: Trinpanchmooladi ghrita, Reference: Vangsen samhita ashmari aadhyaya (52-55), Route: Urethral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients present with sign and symptoms of Pittaj Mutrakrichhra and Urinary tract infection as mentioned in diagnostic criteria.
ii. Patient willing to participate.
iii. Patients in the age group of 25-70 years.
|
|
| ExclusionCriteria |
| Details |
i. Patients not willing for trial.
ii. Known case of Ureteric stone, Pyelonephritis, Polycystic Kidney Disease, Neurogenic Bladder urethral stricture
iii. Patient with uncontrolled Hypertension, Diabetes Mellitus, Malignancy, anorectal disease and other chronic illness.
iv. Pregnant & lactating women.
v. Patient suffering from chronic illness requiring immediate hospitalization.
vi. Any condition which the investigator thinks may compromise with the safety of the patient
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To fulfil subjective and objective criterian Efficacy and effect of trinpanchmooladi ghrita and mutradahaantak churana on growth of micro-organism causing Urinary Tract Infection.
To observe untoward effect of Uttarbasti in the patients of UTI if any.
To evaluate the efficacy and treatment protocol with –Nitrofurantoin
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe untoward effect of Uttarbasti in the patients of UTI if any
To evaluate the efficacy & treatment protocol with Nitrofurantoin
|
7 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2026 |
| 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="0"
Months="8"
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
|
I would like to publish my research trail after completion as soon as possible. A total of 30 subjects will be studied in 3 groups.10 study participant will be managed with Trinpanchmooladi ghrita uttar basti and 10 will be managed with Mutradahaantak churana with Chandanaadi arka as anupana and in rest 10 participant nitrofurantoin will be given. |