CTRI

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CTRI Number

CTRI/2025/05/087553 [Registered on: 26/05/2025] Trial Registered Prospectively

Last Modified On:

24/05/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Study of Ayurvedic medicine Trikantakadi Yoga in the management of Mutrakrucchra

Scientific Title of Study

Randomized controlled clinical trial to evaluate the efficacy of Trikantakadi Yoga in the management of Mutrakrucchra (Urinary Tract Infection) in children

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Jyoti Kailasrao Bais
Designation	MD Scholar - Kaumarbhritya Department
Affiliation	Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya , Aurangabad
Address	CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi OPD NO. 14 Kaumarbhritya Department 431011 Aurangabad Maharashtra India CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi OPD NO. 14 Kaumarbhritya Department 431011 Aurangabad Maharashtra India Aurangabad MAHARASHTRA 431011 India
Phone	9970565378
Fax
Email	jyo1234566@gmail.com

Details of Contact Person
Scientific Query

Name	K S Ratnaparkhi
Designation	HOD PROFESSOR
Affiliation	Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya , Aurangabad
Address	CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi OPD NO. 14 Kaumarbhritya Department 431011 Aurangabad Maharashtra India CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi OPD NO. 14 Kaumarbhritya Department 431011Aurangabad Maharashtra India Aurangabad MAHARASHTRA 431011 India
Phone	9421771722
Fax
Email	karunaratnaparkhi@gmail.com

Details of Contact Person
Public Query

Name	K S Ratnaparkhi
Designation	HOD PROFESSOR
Affiliation	Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya , Aurangabad
Address	CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi OPD NO. 14 Kaumarbhritya Department 431002 Aurangabad Maharashtra India CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi OPD NO. 14 Kaumarbhritya Department 431002 Aurangabad Maharashtra India Aurangabad MAHARASHTRA 431002 India
Phone	9421771722
Fax
Email	karunaratnaparkhi@gmail.com

Source of Monetary or Material Support

CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 431011 Aurangabad Maharashtra India

Primary Sponsor

Name	Jyoti Kailasrao Bais
Address	CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 43 1002 OPD NO. 14 Kaumarbhritya Department 431002 Aurangabad Maharashtra India
Type of Sponsor	Other [self]

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
Jyoti Kailasrao Bais	CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad	CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 43 1002 OPD NO. 14 Kaumarbhritya Department 431002 Aurangabad Maharashtra India Aurangabad MAHARASHTRA	9970565378 jyo1234566@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Chhtrapati Shahu Maharaj Shikshan Sanstha Institutional Ethical Comittee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:Z00-Z99\|\|Factors influencing health status and contact with health services. Ayurveda Condition: MUTRAKRUCCRAM,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Trikantakadi Yoga, Reference: Bhavprakash Madhyakhanda Chikitsaprakaran Mutrakrucchra Adhikar 35/38, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Nil
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Eladi Yoga, Reference: Yogratnakar Mutrakrucchra Nidan - Chikitsaprakaran Shlok 56, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Nil

Inclusion Criteria

Age From	6.00 Year(s)
Age To	16.00 Year(s)
Gender	Both
Details	1.Age group between 6 years to 16 years 2.Symptoms described in the context of Mutrakrucchra 3.Patients irrespective of their gender, religion, and economic status will be included in the study

ExclusionCriteria

Details

1.Patients below 6 years and above 16 years 2.Patients with congenital abnormalities and other systemic diseases

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1.Dysuria should be decrease 2.Burning Micturation should be decrease 3.Frequent Urination should be decrease	Baseline ,5th , 10th day

Secondary Outcome

Outcome	TimePoints
1. No. of pus cells should be decrease 2.ph of urine should be decrease	Baseline ,5th, 10th day

Target Sample Size

Total Sample Size="92"
Sample Size from India="92"
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)

20/06/2025

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="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

According to Ayurveda Mutrakrucchra is a disease of Mutravaha Strotas.Mutrakrucchra is a broad term which covers the conditions described in modern medical science as Urinary Tract Infection (UTI). The Pratyatma Lakshana of Mutrakrucchra is "Dukhena Mutra Pravrutti" means discomfort during micturation. In Mitrakrucchra, the vitiated Pitta Dosha along with Vata (mainly Apana Vayu) on reaching Basti afflicts the Mutravaha Strotas .

Mutrakrucchra is also found as a Lakshana in many diseases such as Ashmari, Mutraghata, Mutrajvriddhi, Arsha and Gulma.

The Lakshana of MUTRAKRUCCHRA in children is described by Acharya Kashyap in Vedana adhyay.

Rationale of study

Urinary tract is the third commonest site of infection in children after gut and respiratory tract, involving lower urinary tract (cystitis, urethritis) or upper urinary tract infection (pyelonephritis) or both.

About 2-8% of children develop UTI by the age of 14 years.About 1-3% boys and 3-8% girls suffer with at least one attack of symptomatic UTI by 14 Years of age.It is an important cause of morbidity and might result in renal damage often in association with vesicoureteric reflux .

Dysuria is one among the important symptoms of the lower UTI by which the patients daily activities are hampered. With the introduction of effective antibiotics, problem has been solved to some extent but the use of antibiotics have side effects, chances of re-infection and relapse even after long term therapy. Simultaneously increasing incidence of resistance and high cost of therapy are common problems. So, there is a need to find low cost, harmless and preventive drug prepared from natural resources in the management of Mutrakrucchra.

Bhav Prakash has mentioned Trikantakadi Yoga for the treatment of Mutrakrucchra in children which consists of Trikantak, Aragwadh, Darbha, Kasha, Duralabha, Parvatbheda and Haritaki.