FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Nil 
 
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  
Name  Address 
NIL  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 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  
Status 
Not Applicable 
 
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

 

 
Close