| CTRI Number |
CTRI/2025/05/086719 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of vidari kand in pittaja mitrakruchha an ayurvedic disease similar to urinary tract infection |
|
Scientific Title of Study
|
Single Arm Clinical Study To Assess The Efficacy Of Vidari Kand Kwath In
The Management Of Pittaja Mutrakruchha With Special Reference To 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 Sharik Manjur Mulla |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college
and hospital PG Institute and Research center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India
Sangli
MAHARASHTRA
415409
India |
| Phone |
7083786241 |
| Fax |
|
| Email |
sharikmulla.1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinandan Patil |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890205000 |
| Fax |
|
| Email |
drabhinandanpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinandan Patil |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
MAHARASHTRA
415409
India |
| Phone |
9890205000 |
| Fax |
|
| Email |
drabhinandanpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic medical college hospital post graduate institute and research center Urun Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Sharik Manjur Mulla |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli |
| 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 Abhinandan Patil |
opd number 1 ground floor , LRPAMC Urun islampur , sangli |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA |
9890205000
drabhinandanpatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee LRP Ayurvedic medical college and hospital and PCT and RC Approved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidari, Reference: Charak samhita chikitsasthan adhyay 26/51, Route: Oral, Dosage Form: Kshara , Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Sharkara , madhu), Additional Information: Using sharmara and madhu as prakshep dravya
With kashay
In amount 3.125 gm |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of Pittaja Mutrakruchha as per
Ayurvedic samhita will be randomly selected .
Urine pus cells more than 5 / hpf.
RBCs in urine more than 4 / hpf.
Symptoms started within 15 days of period.
3 or more symptoms of urinary tract infection from following
symptoms and presence of pus cells or RBC (25)
Dysuria
Macrohematuria
Nycturia
Suprapubic pain
Incontinence over urine
Offensive or foul smell |
|
| ExclusionCriteria |
| Details |
Patient with diabetes mellitus.
Patients with known case of any systemic disease or urinary calculi.
Patient with surgical history of any part of urinary tract.
Patients with catheter related urinary tract infection.
If crystals in urine are present. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see effectiveness of vidari kand kwath in management of pittaja mutrakruchha |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe any adverse effect of vidari kamd kwath in patients of urianry tract infection |
15 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
23/05/2025 |
| 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 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
|
Mutrakruchha is one of common disorder of mutravaha strotas. Mutrakruchha has been documented in the Ayurveda by various scholars; Sushruta samhita, Charaka samhita, Ashtang hruday, Madhava nidan etc. According to Madhav nidan Mutrakruchha is painful and difficulty in micturation. According to Madhav nidan a type of Mutrakruchha; Pittaja Mutrakruchha presents with following symptoms Yellowish, with blood, painful, with burning sensation, with difficulty and frequent micturation are the symptoms seen in Pittaja Mutrakruchha . It Is a diseases where difficulty in micturation is due to sadaaha mutrapravruti (Burning sensation), sashool (painful), muhurmuhur mutrapravrutti. (frequent urination), burning micturation, painful micturition. Urine is byproduct of blood filtering system that is excretory system, which is performed by kidneys. Kidneys excretes different metabolic wastes that can harm our body with water as a solvent. It also removes excess amount of water. Urine usually drained out without any bacterial or infective contamination, sometimes it gets infected or contaminated which is called as Urinary Tract Infection. Urinary Tract Infection is any type of infection of whole urinary tract. The urinary system includes Kidneys, Ureters, Urinary bladder, Urethra. Thus Urinary Tract Infection includes infection of above organs, however it usually involves infection of Urinary Bladder and Urethra which is called as Lower Urinary Tract Infection. As 50-80% of women in general population experience at least one UTI in their lifetime and about 20 to 30% of women will have recurrent UTI.
Prevalence rate of UTI in India is 21 to 31 %(21) as urine is excellent culture for bacteria.
Clinical diagnosis of Urinary Tract Infection is primarily based on medical history which have following symptoms. Dysuria, nycturia, incontinence over urine, Fever Macrohematuria, suprapubic pain, offensive or foul smell, burning micturation. Symptoms of Urinary Tract Infection are similar to that of Pittaja Mutrakruchha. Hence Pittaja Mutrakruchha can be co-related with Urinary Tract Infection.
Vidari, Madhu and Sharkara are common Ayurvedic drugs which are easy to administer. Vidari has other properties such as Balya, Bruhaniya and also is a Pittashamak drug.
This combination of drug administration in Pittaja Mutrakruchha is written in Charak samhita chikitsa and due to above benefits these are selected in management of Pittaja Mutrakruchha.
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