| CTRI Number |
CTRI/2023/05/052734 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
15/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
the comparative study of mutrakrucchara kwatha and trunpanchmula kwatha in the management of pittaja mutrakruccha |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF MUTRAKRICCHAHARA KWATHA AND TRUNAPANCHAMULA KWATHA IN THE MANAGEMENT OF PITTAJA MUTRAKRUCCHA W.S.R URINARY TRACT INFECTION. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shradha Santuka Pandagale |
| Designation |
P.G. Scholar (kayachikitsa) |
| Affiliation |
Bharati Vidyapeeth Deemed to be university,pune |
| Address |
Dept. of kayachikitsa ,1st floor,college of Ayurved ,Bharati vidyapeeth Deemed to be University ,Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7020516492 |
| Fax |
|
| Email |
shradhapandagale53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay A Durve |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be university,pune |
| Address |
Dept. of kayachikitsa ,1st floor,college of Ayurved ,Bharati vidyapeeth Deemed to be University ,Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9850044207 |
| Fax |
|
| Email |
dr.sanjaydhurve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shradha pandagale |
| Designation |
P.G. Scholar (kayachikitsa) |
| Affiliation |
Bharati Vidyapeeth Deemed to be university,pune |
| Address |
Dept. of kayachikitsa ,1st floor,college of Ayurved ,Bharati vidyapeeth Deemed to be University ,Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9850044207 |
| Fax |
|
| Email |
dr.sanjaydhurve@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Kayachikitsa, 2nd floor,College of Ayurved and Hospital, BVDU, Pune 43 |
|
|
Primary Sponsor
|
| Name |
Department of kayachikitsa college of Ayurved bharati vidyapeeth Deemed to be university |
| Address |
College of Ayurveda,Bharati Vidyapeeth (Deemed To Be) University Pune,Maharashtra. 411043 |
| 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 |
| Shradha Pandagale |
Bharati Ayurved Hospital |
2nd floor, Kayachikitsa OPD and IPD, Bharati Vidyapeeth(deemed to be university) College of Ayurved, Pune 43
Pune
MAHARASHTRA |
7020516492
shradhapandagale53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N300||Acute cystitis. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trunapanchamoola kwatha, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mutrakrucchahara kwatha, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: sukhoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.The diagnosed Patients of Pittaj Mutrakruccha according to classical signs or symptoms.
2. The age between 16 to 50 years.
3. Patients of either sex.
4. Patients having sign or symptoms of urinary tract infection.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy , lactation.
2. the patient having surgical problem of UTI, its complication.
3. patient suffering from any other systemic disorders like cancer, kochs, HIV, VDRL,BPH, diabetes , STD.
4.Severe Traumatic causes.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of mutrakrucchhara kwath will be assessed in pittaja mutrakruccha. |
14 days study will 3 follow ups on 4th, 7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Peet mutrata, Saruja mutrata,
Sadaha mutrata, Kruchra mutrata, Sarakta mutrata and Frequent Micturation will be assessed.
|
14 days study with 3 follow ups on 4th, 7th and 14th day. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
26/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/05/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mutrakruccha is the disease of mutravaha strotas characterized by difficulty in micturition. The aim of study is to see the effectiveness of mutrakrucchahara kwath in pittaja mutrakruccha w.s.r to UTI. This is a comparative study and in this study total 40 patients will be recruited. Trial group of 20 patients will be given mutrakrucchahara kwath and Control group of 20 patients will be given Trunapanchamoola kwath for 14 days. Results will be drawn according to the observations. |