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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: | 2 | Comparator Arm | Drug | Classical | | (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. |