CTRI Number |
CTRI/2019/02/017710 [Registered on: 19/02/2019] Trial Registered Prospectively |
Last Modified On: |
22/03/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Effect of Trikantakadya Guggulu in Mutrakrichchra (urinary tract infection) |
Scientific Title of Study
|
A Clinical Study on the Management of Mutrakrichchra With Trikantakadya Guggulu |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shailesh Vinayak Deshpande |
Designation |
Professor |
Affiliation |
Parul Institute of Ayurved, Parul university |
Address |
Department of Kayachikitsa, Parul Institute of Ayurved, Parul University, AP - Limda, Tal - Waghodia, Vadodara
Vadodara GUJARAT 391760 India |
Phone |
|
Fax |
|
Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Payjani Dubey |
Designation |
PG Scholar |
Affiliation |
Parul Institute of Ayurved, Parul university |
Address |
Department of Kayachikitsa, Parul Institute of Ayurved, Parul University, AP - Limda, Tal - Waghodia, Vadodara
Vadodara GUJARAT 391760 India |
Phone |
7748084342 |
Fax |
|
Email |
payald613@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Payjani Dubey |
Designation |
PG Scholar |
Affiliation |
Parul Institute of Ayurved, Parul university |
Address |
Department of Kayachikitsa, Parul Institute of Ayurved, Parul University, AP - Limda, Tal - Waghodia, Vadodara
Vadodara GUJARAT 391760 India |
Phone |
7748084342 |
Fax |
|
Email |
payald613@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Dean Faculty of Ayurved Parul University |
Address |
Parul Institute of Ayurved, Parul University, AP - Limda, Tal - Waghodia, Vadodara, Gujarat 391760 |
Type of Sponsor |
Private medical college |
|
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 Shailesh Vinayak Deshpande |
Parul Ayurved Hospital |
OPD No 106, Parul Ayurved Hospital, Parul Institute of Ayurved, Parul University, AP - Limda, Tal - Waghodia, Vadodara 391760 Vadodara GUJARAT |
9763104451
dr.shaileshd@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee for Human Research |
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 |
Not Applicable |
Not Applicable |
Intervention |
Trikantakadya guggulu 1.5 gm thrice daily after food with water for 14 days |
Trikantakadya guggula is classical Ayurvedic medicine having reference Yogaratnakara, Mutrakrichcha Adyaya Chapter 16, Verse 47 - 48. It contains Gokshur (Tribulus terrestris) Guggul (Commiphora mukul), Haritaki (Terminalia chebula), Bhibitaki (Terninalia bellerica), Amalki (Emblica officinalis), Nagarmotha (Cyperus scariosus), Shunthi (Zingiber officinale),
Marich (Piper nigrum)
Pippali (Piper longum). The medicine will be given 1.5 gm thrice daily after meals with water for 14 days |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients diagnosed with mutrakrichchra (lower UTI) based on signs symptoms.
Positive urine microscopy (pus cells>10/hpf) in centrifuged mid-stream urine. |
|
ExclusionCriteria |
Details |
UTI with secondary systemic disease like renal failure, Uncontrolled systemic disease like Diabetes Mellitus Hypertension & any anatomical abnormalities Evidence of renal calculus. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Effect on number of pus cells and RBC per HPF. |
At base line and at the end of 14 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Effect on symptoms of Mutrakrichcha - Burning micturition(Sadaha mutra pravritti) and Dysuria(Saruja mutra pravritti) |
At base line and after each 7 days till the end of 14 days |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
01/03/2019 |
Date of Study Completion (India) |
15/03/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
01/04/2020 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Mutrakrichchra is a disease of mootravaha strotas the term Mutrakrichchra comprise of two words
-Mutra and Krichra.The term Mutram is derived from the root Muta+Ghanzh
prtayaya which means Mutra prasravane i.e ooze.The term Krichchra is derived
from the root Krish-Kaste means causing trouble or painful.The disease in which
urine is passed with difficulty is called Mutrakrichchra
.Considering it can be inferred that Mutrakrichchra
is a condition of urogenital system with dysuria as prime symptom which
includes UTI.[i]
Urinary tract infections is an infection that
affects parts of urinary tract when it affects the lower urinary tract.UTI are
caused by bacterium Escheichia coli,[ii]cause
80% of acute infections in patients withouts urologic abnormalities or calculi
Other gram negative rods,especially proteys and Kleibseella and occasionally
Enterobacter,account for a smaller proportion of uncomplicated infections some
lifestyle disorders like poor personal hygiene, having a urinary catheter,bowel
incontinence,kidney stone,some forms of contraception’s .UTI is the most common
bacterial infections managed in general medical practice and account for 2-5%
of consultations ,upto 50%of women have a UTI at some time .The prevalance of
UTI in women is about 3% at the age of
20 ,increasing by about 1% in each subsequent decade.[iii]
Cystitis and urethritis the
two forms of lower urinary tract infections (LUTI) are nearly 10 times more
common in males than females, mainly in reproductive age. Bacterial presence
places the entire urinary system at risk of invasion. Dysuria is one among the
important symptoms of lower UTI by which the patients, daily activities are
hampred. Patient with cystitis and urethritis may be asymptomatic or present
with frequency,urgency,supra pubic pain and dysuria .[iv]
These conditions of lower
UTI has similar symptoms of mootrakrichra like muhurmootra pravrutti,sadaaha mootrapravrutti,saruja
mootrapravrutti. In Ayurveda there are so many formulations mentioned for the
mootrakrichra, even though number of researches have been carried out still
there is need of an effective and safe formulation for this disease. [v]
The method of management of
UTI are mainly by antibiotics. Even though they are useful they involve
considerable amount of risk and are also expensive at the same time the
infective organism develops resistance to antibiotics.So there is need of safe
palatable, cost effective medicine.
The trikantakadya guggula
from yogaratnakara contains gokshur
guggul, haritaki, bhibitaki, amalki , nagarmotha.Each and every
ingredient is having mootra krichra property. For that an attempt has been
taken for research work to see the efficacy of trikantakadya guggulu[vi]
[i] Urinary tract
infections article by Hegde Gajanan
[ii] Journal of Emerging Infectious
on Urinary Tract infection
[iii] Diagnosis of Urinary Tract Infection article
by Guido Schiemann
[iv] Shah NS.API text book of medicine.8th edi
Mumbai:The association of physicians of india 2008 p.761
[v] Charaka Samhita :Chikitsa sthana In chapter 26
sloka 34-35 Varanasi:Chaukambha Prakashan 2005 p.870
[vi] Yogarastnakara
mutrakrichchra chikitsa p.508
|