| CTRI Number |
CTRI/2025/04/084558 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy Of Sahacharadi Taila Uttar Basti In The Management Of Chronic Lower UTI In Females . |
|
Scientific Title of Study
|
Efficacy Of Sahacharadi Taila Uttar Basti In The Management Of Mutrakrichhram (Chronic Lower Urinary Tract Infections ) In Females An Open Labelled Randomized Standard Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adithya Divakaran |
| Designation |
P.G. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9495151067 |
| Fax |
|
| Email |
adhiram1827@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P B Joshi |
| Designation |
Reader |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427226504 |
| Fax |
|
| Email |
pbj@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr P B Joshi |
| Designation |
Reader |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427226504 |
| Fax |
|
| Email |
pbj@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute Of Teaching and Research in Ayurveda Jamnagar 361008 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda Jamnagar 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Adithya Divakaran |
Institute of Teaching and Research in Ayurveda, Jamnagar |
Shalya Tantra OPD -03 , Room no-201 , Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar
GUJARAT |
9495151067
adhiram1827@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Teaching and Research in Ayurveda |
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 | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Susrutha chikitsa 37th chapter, Procedure details: Uttarbasti with 20 ml sahacharadi taila through mutramarga once in a day for 7 days .)
(1) Medicine Name: Sahacharadi taila, Reference: Sahasrayogam taila prakaran, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: Chandraprabha vati, Reference: Sharngadhara samhitha Madhyama khanda 7/40 -49, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: tds, Duration: 7 Days(3) Medicine Name: Trnapanchamula kwath, Reference: Bhaisajya Ratnavali mutrakrichra Rogadhikara 10, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Bladder Irrigation with Povidone Iodine solution | Bladder irrigation with 20 ml of 10% Povidone Iodine diluted with normal saline (1:5) through urethral route once in a day for 7 days . |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. The only female patients of age 18 to 60 years.
2. The patients having either dysuria or any other signs and symptoms of Mutrakrichhram (Chronic lower urinary tract infections)
3. Patients with positive findings for urine R/M examination.
4. Recurrent / chronic UTI patients ( defined as occurrence of 2 or more UTIs within months or 3
within a year ) |
|
| ExclusionCriteria |
| Details |
1. Patients of age below 18 years and above 60 years.
2. Patients of acute UTI , acute cystitis, malignancy, congenital deformities of urogenital
tract or any abdominal-pelvic pathology.
3. Systemic diseases like chronic renal failure (CRF), Uncontrolled Hypertension (BP greater than 150/90 mmHg), diabetes mellitus (RBS greater than 140 mg/dl),
4. Patient of k/c/o Tuberculosis, Paralysis, and Parkinsonism will be excluded.
5. Known case of cardiac diseases (H/O- MI, IHD).
6. Patient having HIV, HBsAg, HCV, VDRL positive
7. Renal failure
8. Pyelonephritis
9. Urinary calculi anywhere in the urinary tract
10. Pregnancy and lactating women and women with sweta pradara . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in the features of Mutrakrichhram (chronic lower urinary tract infections) as mentioned in diagnostic criteria. |
1 DAY, 8 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absence of recurrence in follow up period |
15 day , 22 day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2025 |
| 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="0"
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
|
Urinary tract infection may be conveniently divided into lower and upper tract infection. Lower urinary tract infections (LUTI) also known as uncomplicated urinary tract infection is a bacterial infection of the bladder and associated structures. LUTI is the most common bacterial infection managed in general practice. Mutrakrichhram, the disease of Mutravaha Srotas is a condition where person experiences difficulty in micturition. Uttar Basti is one among Panchakarma treatments. It is the Basti administered through the urinary passage in men and women and also through vagina. Since this imparts extraordinary benefits it is called as Uttar Basti . The global prevalence of UTI is around 150 million per year. Research has highlighted a prevalence range for UTIs in Indian women from 3.14% to 19.87%. It is highest in young women (18 - 37 years old) and older men (> 68 years old) .As the prevalence of this disease is very high especially in females and it has become a major health problem affecting large scale of population this disease has been selected. Though there are research works related to the oral administration in Mutrakrichhram but not much on Uttar Basti, this has been considered as an intervention for the same. The standard care for UTI are antibiotics, which are often used in the beginning itself in a wide spread way. Injudicious use of antibiotics makes the people prone to many drug resistance. Considering these factors, an immediate need exists for a strong and safe intervention. Uttar Basti has been considered as one of the treatment modality . As Sahacharadi Taila has been indicated for Mutrakrichhram in classics an approach is made to know the efficacy of the same. In this trial it is to evaluate and compare the effect of Sahacharadi Taila Uttar Basti with Povidone Iodine bladder irrigation in the management of Mutrakrichhram (Chronic lower urinary tract infections) in females. 30 patients having 2 or more than 2 signs and symptoms of Mutrakrichhram between the age group 18 to 60 years will be selected from OPD and IPD hospital of ITRA, Jamnagar and from special camps in the clinical study. Special diagnostic camps will also be arranged to enrol the patients . The patients will be enrolled into two groups .Group A will be given Uttarbasti with 20 ml Sahacharadi Taila for 7 days and group B will be given bladder irrigation with povidone iodine 10 % ( diluted with normal saline 1;5 ) with Chandraprabha vati 2TDS A/F And Trnapanchamulakwatha 10g BD B/F common in both groups . In this study, obtained data will be analyzed on the basis of proper logics and reasoning to find out the Efficacy of Sahacharadi Taila Uttar Basti in the management of Mutrakrichhram (Chronic lower urinary tract infections) in females and further conclusions will be derived from the study. The data generated during the present study will be presented in a systemic manner and shall be analysed statistically . |