| CTRI Number |
CTRI/2025/05/087004 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the effect of Aaragvadhadi Kwatha and Gokshur Churna in the management of to UTI |
|
Scientific Title of Study
|
An open randomised clinical study to evaluate the efficacy of Aaragvadhadi Kwatha and Gokshur Churna in the management of Mutrakrichhhra w.s.r. to Urinary tract Infection. |
| Trial Acronym |
na |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manik Soni |
| Designation |
Senior Lecturer |
| Affiliation |
|
| Address |
RGGPG Ayurvedic College and Hospital Paprola Baijnath Distt Kangra (HP) 176115
Hospital builiding Room no. 317
RGGPG Ayurvedic College and Hospital Paprola Baijnath Distt Kangra (HP) 176115
Hospital building Room no. 317
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219121014 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Chaudhary |
| Designation |
Principal-cum-Dean |
| Affiliation |
|
| Address |
RGGPG Ayurvedic College and Hospital Paprola Baijnath Distt Kangra (HP) 176115
Hospital building Room no. 317
RGGPG Ayurvedic College and Hospital Paprola Baijnath Distt Kangra (HP) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
RGGPG Ayurvedic College and Hospital Paprola Baijnath Distt Kangra (HP) 176115
Hospital building Room no. 317
RGGPG Ayurvedic College and Hospital Paprola Baijnath Distt Kangra (HP) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418724919 |
| Fax |
|
| Email |
aagney25thakur@gmail.com |
|
|
Source of Monetary or Material Support
|
| PROF. DR. Vijay Chaudhary |
|
|
Primary Sponsor
|
| Name |
Dr Vijay Chaudhary |
| Address |
RGGPG Ayurvedic College and Hospital Paprola Baijnath Distt Kangra (HP) 176115 |
| Type of Sponsor |
Government medical college |
|
|
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 Manik Soni |
RGGPG Ayurvedic College and Hospital Paprola Baijnath Distt Kangra (HP) 176115 |
RGGPG Ayurvedic College and Hospital Paprola Baijnath Distt Kangra (HP) 176115 Hospital building Room no. 317
Kangra
HIMACHAL PRADESH |
819121014
drmsony@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(Human) |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aaragvadhadi Kwatha, Reference: Harit Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Gokshur Churna, Reference: Charak sutra 24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet Norfloxacin 400mg | Norfloxacin 400mg twice daily after meals for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with sign & symptoms of mutrakrichhra of either gender between age group of 18-70 years. |
|
| ExclusionCriteria |
| Details |
patients not willing for trial below age of 18 years and above 70 years having chronic renal disease, malignancy and TB of urinary tract, pregnant and lactating mothers or any other condition which investigator thinks may compromise the safety of subject. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effect of Aagravadhadi Kwatha and Gokshur Churna in management of Mutrakrichhra w.s.r. to UTI |
To see the effect of Aagravadhadi Kwatha and Gokshur Churna in management of Mutrakrichhra w.s.r. to UTI |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical safety and any untoward effect of Aagravadhadi Kwatha and Gokshur Churna in Mutrakrichhra |
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="0"
Months="0"
Days="7" |
|
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
|
At the end of clinical trial results obtained will be statistically analysed and will be presented in the form of thesis. |