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CTRI Number  CTRI/2021/10/037188 [Registered on: 08/10/2021] Trial Registered Prospectively
Last Modified On: 04/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare the effect of Ervaarubeejadi Choorna(Herbal powder) and Narikeladi yoga (Herbal powder) in Garbhini Mutrakricchra ( Lower Urinary Tract Infection) 
Scientific Title of Study   An Open Lable Double Arm Clinical Study to compare the effect of Ervaarubeejadi choorna and Narikeladi yoga in Garbhini Mutrakricchra vis-a-vis Lower 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 Shilpa J 
Designation  PG Scholar 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 
Address  208 Dept of Prasooti Tantra evam stree roga Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline road Rpc Layout Vijayanagar Bengaluru

Bangalore
KARNATAKA
560104
India 
Phone  9567628223  
Fax    
Email  shilpa_vivek12@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anupama V 
Designation  Professor and HOD 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 
Address  208 Dept of PTSR Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline road Rpc Layout VijayanagarBengaluru

Bangalore
KARNATAKA
560104
India 
Phone  9845442660  
Fax    
Email  dr.anupama.v@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anupama V 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 
Address  208 Dept of PTSR Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline road Rpc Layout VijayanagarBengaluru

Bangalore
KARNATAKA
560104
India 
Phone  9845442660  
Fax    
Email  dr.anupama.v@gmail.com  
 
Source of Monetary or Material Support  
Sri Kalabyraveshwara Ayurvedic Medical college Hospital and Research centre 
 
Primary Sponsor  
Name  Shilpa J 
Address  Dept of PTSR Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road Rpc Layout Vijayanagar Bangalore 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR KIRAN M GOUD  Sri Kalabyraveshwara Swamy Ayurvedic Medical College  Dept of PTSR Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road Rpc Layout Vijayanagar Bangalore
Bangalore
KARNATAKA 
9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKAMCHRC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O239||Unspecified genitourinary tract infection in pregnancy. Ayurveda Condition: GARBHINIMUTRAKRICCHRA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ervaarubeejadi Churna, Reference: Cakradutta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Tandulambu), Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Narikeladi Yoga, Reference: Yogaratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Narikelambu), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Both Primi and Multigravida
Having Lakshanas of Mutrakricchra
Between age group 18 years and 30 years
Having continous lower abdominal pain
Laboratory investigation showing pus cells and epithelial (>2-3cells/hpf) in urine
Non covid and post covid patientsfulfilling the above crieteria 
 
ExclusionCriteria 
Details  Patients suffering from other systemic disorders which interfere with the course of treatment 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Ervaarubeejadi yoga and Narikeladi yoga will help in curing Garbhini Mutrakricchra with 7 days intervention   one and half year 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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)   01/06/2022 
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  

Pregnancy is one of the important phase in the life of a women, hence health of the pregnant women is to be taken care properly and this can be achieved by routine antenatal care. During antenatal checkups it is observed that pregnancy can be complicated by many infections, among which Urinary tract infections are the most common.[1] In pregnancy the overall incidence of lower UTI is 8%.

Symptoms of UTI can be correlated with Mutrakricchra i.e, Mutrakricchratha,Mutradaha,Muhurmuhur Mutratha which is explained in all Brihatrayees and Laghuthrayees.

            UTI is characterised by dysuria, increased frequency of micturition, suprapubic tenderness, urgency and hematuria.  Untreated asymptomatic Lower UTI will lead to upper UTI which have been associated with increased incidences of  premature delivery ,intra uterine growth retardation, low birth weight ,maternal hypertension and pre-eclampsia.In pregnancy, significant physiological changes occur in the urogenital tract, resulting in urinary stasis and uretero vesical reflux.Urinary progestins and estrogens lead to a decreased ability of the lower urinary tract to resist invading bacteria.These factors contribute to the development of UTI during pregnancy. Organisms that cause urinary infections are those from the normal perineal flora. Escherichia coli accounts for 80 to 90 percent of infections In modern science antibiotics have been used to combat UTI. Antibiotics have their own limitations like development of resistance in the micro-organisms and potential teratogenic activity.

According to Acharya Kashyapa Garbhini need not be considered as a separate subject, so in  Garbhini mutrakricchra, Nidana Panchaka and Chikitsa of Mutrakricchra can be adopted. In ayurvedic classics ,many yoga’s are explained to treat mutrakricchra. So an attempt is being made to treat Garbhini Mutrakricchra with Ervaarubeejadi Choorna and Narikeladi Yoga,which are cost effective, easily available& palatable to the patient.

 

 
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