| CTRI Number |
CTRI/2025/05/087602 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Experimental and Clinical Study to Evaluate the effect of Shatavaryadi Kwath on Pittaja Mutrakrichhra w.s.r. to Urinary Tract Infection. |
|
Scientific Title of Study
|
An Experimental and Clinical Study to Evaluate the effect of Shatavaryadi Kwath on Pittaja 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 |
Dr Swapnil Saini |
| Designation |
Reader |
| Affiliation |
RAJIV GANDHI GOVT. POST GRADUATE AYURVEDIC COLLEGE & HOSPITAL, PAPROLA, KANGRA H.P. |
| Address |
PG Department of Rog Nidan , Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola , Distt. Kangra ,
H.P.
PG Department of Rog Nidan , Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola , Distt. Kangra ,
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8629036838 |
| Fax |
|
| Email |
sainiswapnil49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amritanshu Saroch |
| Designation |
PG Scholar , Department of Rog Nidan |
| Affiliation |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College & Hospital, Paprola, Kangra H.P. |
| Address |
PG Department of Rog Nidan , Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola , Distt. Kangra ,
H.P.
PG Department of Rog Nidan , Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola , Distt. Kangra ,
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219494473 |
| Fax |
|
| Email |
Amritanshusaroch777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnil Saini |
| Designation |
Reader |
| Affiliation |
RAJIV GANDHI GOVT. POST GRADUATE AYURVEDIC COLLEGE & HOSPITAL, PAPROLA, KANGRA H.P. |
| Address |
PG Department of Rog Nidan , Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola , Distt. Kangra ,
H.P.
PG Department of Rog Nidan , Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola , Distt. Kangra ,
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8629036838 |
| Fax |
|
| Email |
sainiswapnil49@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola, Kangra, Himachal Pradesh. |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital,
Paprola, Distt. Kangra, H.P. 176115, India |
| 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 Swapnil Saini |
RGGPG Ayurvedic College and Hospital, Paprola |
Room no. 103 Anatomy block, RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra HP 176115, India
Kangra
HIMACHAL PRADESH |
8629036838
sainiswapnil49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) Rajiv Gandhi Govt. Post Graduate Ayurvedic 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:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: PITTAJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavaryadi kwath, Reference: Chakradutt, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Norfloxacin | Norfloxacin 400 mg BD For 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for trial.
Patients of either gender in the age group of 18-70yrs.
Patients fulfilling the diagnostic criteria.
Patients presenting with sign and symptoms of Pittaja Mutrakrichhra w.s.r.
to U.T.I. |
|
| ExclusionCriteria |
| Details |
Patients not willing for trial.
Patients below the age of 18 yrs and above the age of 70 yrs.
Patient having other diseases like diabetes mellitus with Urinary tract
infection.
Case of associated obstructed uropathy and suffering from chronic illness
requiring immediate hospitalization.
Menstruating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in sign and symptoms of Pittaja mutrakrichhra wsr to UTI
|
15 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| An experimental and clinical study to evaluate the effect of Shatavaryadi kwath on Pittaja Mutrakrichhra wsr to UTI |
15 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)
|
23/07/2025 |
| 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="0"
Days="0" |
|
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
|
I would like to publish my research work after completion of the trial as soon as possible. Patients will be selected from OPD/IPD of RGGPG Ayurvedic College and hospital paprola, 2 groups of 15 patients will be registered and assessed to evaluate the effect of Shatvaryadi kwath on Pittaja Mutrakrichhra wsr to UTI. |