| CTRI Number |
CTRI/2024/09/074436 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Ayurvedic medicine Ervarubijadi Yoga in the management of Pittaj Mutrakrucchra. |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Ervarubijadi Yoga in the management of Pittaj Mutrakrucchra in children with special reference to 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 |
Ankita Ramkrushna Bobade |
| Designation |
MD Scholar- Kaumarbhritya Department |
| Affiliation |
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya, Aurangabad |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 43
1002 OPD no. 14 Kaumarbhritya Department Aurangabad
Aurangabad
MAHARASHTRA
431002
INDIA
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
7249361015 |
| Fax |
|
| Email |
abobade142@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Fadnavis |
| Designation |
Associate Professor |
| Affiliation |
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya, Aurangabad |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 43002 OPD no. 14 Kaumarbhritya Department Aurangabad
Aurangabad
MAHARASHTRA
431002
INDIA
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9172933561 |
| Fax |
|
| Email |
dr.kavitafadnavis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Fadnavis |
| Designation |
Associate Professor |
| Affiliation |
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya, Aurangabad |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 43002 OPD no. 14 Kaumarbhritya Department Aurangabad
Aurangabad
MAHARASHTRA
431002
INDIA
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9172933561 |
| Fax |
|
| Email |
dr.kavitafadnavis@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 431002 Aurangabad, Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Ramkrushna Bobade |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 43002
Aurangabad
MAHARASHTRA
431002
INDIA |
| Type of Sponsor |
Other [self] |
|
|
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 Ankita Ramkrushna Bobade |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad
OPD no 14 Kaumarbhritya department Aurangabad
Aurangabad
MAHARASHTRA |
7249361015
abobade142@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhatrapati Shahu Maharaj Shikshan Sanstha Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERVARUBIJADI YOGA |
5 to 12 gm in 3 divided doses with Tandulodak oral for 7 days
|
| Comparator Agent |
SHRUNGATAK HEEM |
20 - 30 Ml shrungatak heem in 3 divided doses for 7 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Day(s) |
| Age To |
16.00 Day(s) |
| Gender |
Both |
| Details |
1. Children of age group 6 years-16 years. 2. Patients irrespective of gender, caste, socioeconomic status. 3. Patients with classical signs and symptoms of pittaj mutrakrucchra sadah, saruja, muhurmuhu mutrapravritti etc. 4. Only those patients will be selected whose parents are willing to give written consent. |
|
| ExclusionCriteria |
| Details |
1. Patients below 6 years and above 16 years. 2. All other types of Mutrakrucchra except Pittaj. 3. 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 |
| Dysuria,Burning Micturition,Frequent Urination |
Baseline 1st, 4th and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No. of pus cells, no. of RBCs, pH OF urine |
Baseline 1st, 4th, 7th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
26/10/2024 |
| 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 Applicable |
| 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 Mutrakricchra
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 Pravruttiâ€
means discomfort during micturition. In Pittaj Mutrakrucchra, 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, urethrits) 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 14yrs of age. They are 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 patient’s 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.
Acharya Charak has mentioned
Ervarubijadi Yoga for the treatment of mutrakrucchra in children which consists
of Ervaru, Yashtimadhu and Devadaru.
|