| CTRI Number |
CTRI/2024/12/078065 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO STUDY EFFECT OF PATHYAGOKSHURADI KWATH AND DHATRYADI KWATH IN PITTAJA MUTRAKRICCHA |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL STUDY TO EVALUATE EFFICACY OF
PATHYAGOKSHURADI KWATH AND DHATRYADI KWATH IN PITTAJA
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 Nainika S Chordiya |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya Solapur |
| Address |
Opd no 3 kayachikitsa department Seth Sakharam Nemchand Jain Ayurved Rugnalaya 118/119 Shukrawar Peth Near Juni Faujdar Chawdi Solapur 413002
MAHARASHTRA
413002
INDIA
Solapur
MAHARASHTRA
413002
India |
| Phone |
8999021176 |
| Fax |
|
| Email |
jainnainika9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channamma s Hiremath |
| Designation |
Professor Kayachikitsa Department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya Solapu |
| Address |
opd no 3 kayachikitsa departmentSeth Sakharam Nemchand Jain Ayurved Rugnalaya 118/119 Shukrawar Peth Near Juni Faujdar Chawdi Solapur 413002
MAHARASHTRA
413002
INDIA
Solapur
MAHARASHTRA
413002
India |
| Phone |
9890630015 |
| Fax |
|
| Email |
channamma.hiremath@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nainika S Chordiya |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya Solapur |
| Address |
opd no 3 kayachikitsa department Seth Sakharam Nemchand Jain Ayurved Rugnalaya 118/119 Shukrawar Peth Near Juni Faujdar Chawdi Solapur 413002
MAHARASHTRA
413002
INDIA
Solapur
MAHARASHTRA
413002
India |
| Phone |
8999021176 |
| Fax |
|
| Email |
jainnainika9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurved Rugnalaya 118/119 Shukrawar Peth near juni faujdar chawdi solapur 413002
MAHARASHTRA
INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Nainika S Chordiya |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya 118/119 Shukrawar Peth near juni faujdar chawdi solapur
SOLAPUR 413002
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 Nainika chordiya |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya solapur |
Opd no 3 kayachikitsa department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA |
8999021176
jainnainika9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
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: Pathyagokshuradi Kwath, Reference: sahastrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatryadi kwath, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject with Classical Sign And Symptoms Of Pittaja Mutrakriccha As Mentioned in Ayurvedic Text
2.Patient with Laboratory Investigation showing Either Pus cell/RBC cell/Epithelial cell in urine will be included
3.Patient with Age Group 18-70 years irrespective of religion,occupation,socioecnomic status will be selected |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and Lactating Mother
2.Urinary Tract infection associated with calculus which will need surgical intervention
3.Patient having Diabetes mellitus ,Benign Prostate Hyperplasia,Pyelonephritis And Traumatic cause
4.Patient Who are not willing to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To Evaluate The Efficacy Of Pathyagokshuradi Kwath in Management Of Pittaja Mutrakriccha
2.To Evaluate The Comparative Efficacy Of Pathyagokshuradi Kwath And Dhatryadi Kwath In Management Of Pittaja Mutrakriccha |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Understand in Detail Samprapti Of Pittaja Mutrakriccha |
15 days with follow up on 7th ,15th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/12/2024 |
| 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="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
|
The Term Mutrakriccha means painful voiding of urine .vittated pitta and pratiloma gati of apana vayu are considered to be the two major factor of pathogenesis of disease Mutrakriccha.Pittaja mutrakriccha is commonest type evokes greater attention due to higher incidence and sudden onset its symptom like daaha ,peeta,sarakta,saruja,,muhurmuhurmutrata resembles sign and symptoms of urinary tract infection .In chikitsa of Pittaja Mutrakriccha Ayurveda Mainly concentrate in bringing back the vitated pitta and pratiloma gati of apan vayu in state of equillibrium .with introduction of antibiotics develop resistance in uti so ayurvedic management of pittaja mutrakriccha will be benificial.The study will be conducted for 15 days ,pathyagokshuradi kwath and Dhatryadi kwath will be given ,before and after treatment assesment will be done with help of investigation Cbc with Esr and urine complete
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