| CTRI Number |
CTRI/2019/10/021480 [Registered on: 01/10/2019] Trial Registered Prospectively |
| Last Modified On: |
10/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two formulations , Mutrakruchchrahara Kwath and Shatavari Gokshura Kwath in patients with Pittaj Mutrakruchra with special reference to urinary tract infection. |
|
Scientific Title of Study
|
Randomized open controlled clinical study to assess the effect of Mutrakruchchrahara kwath in Pittaj Mutrakruchra with special reference to 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 |
Sharang Arun Shirke |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved College Postgraduate Training and Research Centre,Kodoli |
| Address |
Department of Kayachikitsa, Yashwant Ayurved College and PG training and research center, Kodoli
Kolhapur
MAHARASHTRA
416112
India |
| Phone |
9168769133 |
| Fax |
|
| Email |
sharang.shirke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Suryakiran P Wagh |
| Designation |
HOD |
| Affiliation |
Yashwant Ayurved College Postgraduate Training and Research Centre,Kodoli |
| Address |
Department of Kayachikitsa, Yashwant Ayurved College and PG training and research center, Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822846910 |
| Fax |
|
| Email |
suryakiran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharang Arun Shirke |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved College Postgraduate Training and Research Centre,Kodoli |
| Address |
Department of Kayachikitsa, Yashwant Ayurved College and PG training and research center, Kodoli
Kolhapur
MAHARASHTRA
416112
India |
| Phone |
9168769133 |
| Fax |
|
| Email |
sharang.shirke@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharang Arun Shirke |
| Yashwant Ayurved College and PG training and research center, Kodoli |
|
|
Primary Sponsor
|
| Name |
Sharang Arun Shirke |
| Address |
Kumbhar lano no.1
A/p Vathar Tarf Vadgaon,Kolhapur |
| Type of Sponsor |
Other [SELF SPONSERED] |
|
|
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 |
| VD SURYAKIRAN P WAGH |
Yashwant Ayurved College Postgraduate Training and Research Centre |
KODOLI
Kolhapur
MAHARASHTRA |
9822846910
SURYAKIRAN_WAGH@REDIFFMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BORS Committee of the College |
Approved |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gokshura Shatavari Kwath |
50 ml of kwath, twice a day, after meals, for 7 days. |
| Intervention |
Mutrakeuchchrahara Kwath |
50 ml of kwath, twice a day, after meals, for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of pittaj Mutrakruchchra.
Patients irrespective of gender, economic class, caste, religion.
Urine routine examination - pus cells upto 10hpf. |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating mother
Patients with malignancy, diabetes mellitus, BPH, pyelonephritis, traumatic cause
UTI associated with calculus which need surgical intervention
Known HIV and HbSAg positive patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
NORMALIATION OF PUSS CELL COUNT
REDUCTION OF SYMPTOMS LIKE BURNING MICTURITION , FREQUENCY OF URINATION, HEAMATURIA, PAINFUL MICTURITION. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NORMALIATION OF PUSS CELL COUNT
REDUCTION OF SYMPTOMS LIKE BURNING MICTURITION , FREQUENCY OF URINATION, HEAMATURIA, PAINFUL MICTURITION. |
7 DAYS |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/10/2019 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
THE ANTISEPTIC, Volume 117, No 8, August 2020, ISSN 0003-5998, Page No 31 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO ASSESS THE EFFECT OF MUTRAKRUCHCHRAHARA KWATH, 50 ML TWICE A DAY, AFTER MEAL, WITH LUKE WARM WATER, FOR
DAYS AND GOKSHURA SHATAVARI KWATH, 50 ML, TWICE A DAY, AFTER MEAL, WITH LUKE WARM WATER, FOR 7 DAYS IN PATIENTS OF PITTAJ MUTRAKRUCHRA.
PATIENTS WITH AGE 20 TO 60 YEARS , BOTH GENDERS,WITH FOLLOWING SYMPTOMS WILL BE RANDOMLY SELECTED FOR TRIAL. 1) MUTRADAHA I.E.BURNING MICTURITION 2) MUHURMUHUR MUTRAPRAVRUTTI I.E. FREQUENCY OF MICTURITION. 3) SARUJA I.E. PAIN WHILE MICTURITION 4) SARAKTA MUTRATA I.E. RBC IN URINE EXAMINATION . 5) URINE EXAMINATION SHOWING PUS CELLS UPTO 10 HPF
STUDY WILL BE CONDUCTED IN SAME INSTITUTE TILL THE SAMPLE SIZE IS COMPLETED. PRIMARY OUTCOME WILL BE REDUCTION OF SYMPTOMS RELATED TO URINARY TRACT INFECTION ALSO REDUCTION IN PUS CELLS. INTERVENTION DURATION FOR EACH PATIENT WILL BE 7 DAYS. PATIENTS URINE WILL BE EXAMINED ON DAY 0 AND DAY 7 . CONCLUSION WILL BE DRAWN ON ANALYSIS BASED ON SYMPTOM REDUCTION AND PUS CELLS REDUCTION IN BOTH GROUPS.
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