| CTRI Number |
CTRI/2025/02/080036 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study the efficacy of Bhrihatdhatryadi kwath in Urinary Tract Infection |
|
Scientific Title of Study
|
A Single arm clinical study to assess efficacy of Bhrihatdhatryadi kwatha in pittaj mutrakriccha (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 Srushti Pratap Jagdale |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (deemed to be university) |
| Address |
Bharati Vidyapeeth deemed to be University college of ayurved and Hospital Department of kayachikitsa OPD no .04 katraj -Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9096504050 |
| Fax |
|
| Email |
srushtijagdale107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Virendra Pawar |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth (deemed to be university) |
| Address |
Bharati Vidyapeeth deemed to be University college of ayurved and Hospital Department of kayachikitsa OPD no .04 katraj -Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9096743333 |
| Fax |
|
| Email |
virendra.pawar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srushti Pratap Jagdale |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (deemed to be university) |
| Address |
Bharati Vidyapeeth deemed to be University college of ayurved and Hospital Department of kayachikitsa OPD no .04 katraj -Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9096504050 |
| Fax |
|
| Email |
srushtijagdale107@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth deemed to be university college of ayurved and hospital Kartaj Pune 411043 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Srushti Jagdale |
| Address |
Bharati Vidyapeeth (deemed to be university) college ofAyurved and Hospital Katraj Dhankawadi Campus Pune 411043 Maharashtra India |
| 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 Srushti Jagdale |
Bharati VidyapeethDeemed to beUniversity College ofAyurved and Hospital |
Department of kayachikitsa ground floor opd no.4,second floor ipd Bharati vidyapeeth Ayurved hospital
Pune
MAHARASHTRA |
9096504050
srushti.jagdale-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BharatiVidyapeethDeemedtobeUniversityPuneIndiaCollegeofAyurvedpunesatararoad411043ETHICSCOMMITTEE[BVDUCOA EC] |
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: Brihatdhatryadi kwath , Reference: Bhaishajya ratnavali 34/24, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having classical sign and symptoms of Pittaj Mutrakriccha that is Hematuria, Painful micturition,Burning micturition,Difficulty during micturition,Increased frequency,Turbid urine.
2. Subjects of Pittaj Mutrakriccha of age group 18 years to 70 years.
3. Subjects with body temperature ranging from 99 oF to 104oF with Urinary Tract Infection. But if fever is more than 100 oF anti-pyretic will be added with Brihatdhatryadi Kwath.
4. Patients willing for trial and the patients who had no serious organic or metabolic ailments.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and Lactating Women
2. Subject suffering from comorbid conditions like Uncontrolled HTN.
3. Case of associated obstructed uropathy and suffering from chronic illness like CKD.
4. Subject more than 104 oF body temperature.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of pus cells and body temperature to normal range
|
7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in sign and symptoms of Pittaj Mutrakriccha according to Charak Samhita approximately.
|
7 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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
|
The study will conducted after obtaining permission from institutional ethical comittee and will be registar CTRI as per inclusion criteria patient will be selected.Subjective and Objective parameter will be checked. whole research procedure and aim will be clearly inform to patients hence form will be signed by enrolled participants and case report form will be filled. |