| CTRI Number |
CTRI/2021/11/037733 [Registered on: 01/11/2021] Trial Registered Prospectively |
| Last Modified On: |
29/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATHYAGOKSHURADI KWATHA AND SHATAVARYADI KWATHA IN PITTAJA MUTRAKRICCHRA |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATHYAGOKSHURADI KWATHA AND TO COMPARE IT WITH SHATAVARYADI KWATHA IN PAITTIKA MUTRAKRICCHRA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MEGHA MIRAJKAR |
| Designation |
MD SCHOLAR KAYACHIKITSA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
Department of PG Studies in Kayachikitsa Alvas Ayurveda Medical College Moodbidri Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8792111380 |
| Fax |
|
| Email |
meghmm03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ZENICA DSOUZA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Yenepoya Ayurveda Medical College |
| Address |
Department of Kayachikitsa Yenepoya Ayurveda Medical College Naringana Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7829727441 |
| Fax |
|
| Email |
drzenicadsouza@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MEGHA MIRAJKAR |
| Designation |
MD SCHOLAR KAYACHIKITSA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
Department of PG Studies in Kayachikitsa Alvas Ayurveda Medical College Moodbidri Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8792111380 |
| Fax |
|
| Email |
meghmm03@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
MURALIDHAR A MIRAJKAR |
| Address |
C/O M A MIRAJKAR ADITHYA APARTMENTS SARASWATPUR KALAGHATAGI ROAD DHARWAD 580002 |
| Type of Sponsor |
Other [FATHER] |
|
|
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 MEGHA MIRAJKAR |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
KAYACHIKITSA OPD AND IPD ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MOODBIDRI DAKSHINA KANNADA KARNATAKA
Dakshina Kannada
KARNATAKA |
8792111380
meghmm03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL CLINICAL ETHICS COMMITTEE ALVAS AYURVEDA MEDICAL COLLEGE VIDYAGIRI MOODBIDRI INDIA |
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: PITTAJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHATAVARYADI KWATHA, Reference: CHARAKA SAMHITA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: MADHU AND SHARKARA), Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PATHYAGOKSHURADI KWATHA, Reference: SAHASRA YOGA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: MADHU AND SHARKARA), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient within the age group of 16-60 years, who will give their written consent, who will agree to follow the protocol of study. Patients with classical symptoms of pittaja mutrakricchra like peeta mutrata, sarakta mutrata, daaha mutrata, rujayukta mutrata and muhur mutrata. |
|
| ExclusionCriteria |
| Details |
Paittika mutrakricchra caused due to marmabhighata, due to congenital deformity, due to STD. Vulnerable groups like pregnant women, lactating mother. Patients with other systemic disorders like diabetes mellitus, thyroid disorders, cardiac illness and other disorders which interfere with the treatment. Secondary to disorders like Asthma, BPH, acute renal failure, vesico-ureteric reflux, tumor, renal tuberculosis. Patients who are not willing to consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| THE EFFECT OF THE TREATMENT WILL BE ASSESSED BASED ON DETAILED CASE PROFORMA ADOPTING STANDARD SCORING METHODS OF SUBJECTIVE PARAMETERS SUCH AS PAINFUL MICTURITION BURNING MICTURITION DIFFICULTY IN MICTURITION FREQUENCY OF MICTURITION NOCTURIA AND OBJECTIVE PARAMETERS SUCH AS YELLOW COLORATION OF URINE HEMATURIA PUS CELLS/HPF EPITHELIAL CELLS/HPF RBCS/HPF. PRE AND POST INTERVENTIONAL ASSESSMENT WILL BE DONE. |
AT BASELINE 4TH DAY 8TH DAY AND 15TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2021 |
| 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="15" |
|
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
|
THIS IS A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATHYAGOKSHURADI KWATHA AND SHATAVARYADI KWATHA IN PAITTIKA MUTRAKRICCHRA FOR DURATION OF 7 DAYS IN 60 PATIENTS IN OPD AND IPD OF PG STUDIES IN KAYACHIKITSA OF ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MOODBIDRI VIDYAGIRI DAKSHINA KANNADA KARNATAKA INDIA ASSESSMENT WILL BE DONE BASED ON DETAILED CASE PROFORMA ADOPTING STANDARD SCORING METHODS OF SUBJECTIVE AND OBJECTIVE PARAMETERS PRE AND POST ASSESSMENT WILL BE DONE CLINICAL SYMPTOMS WILL BE GRADED AND SCORES WILL BE GIVEN ACCORDINGLY |