| CTRI Number |
CTRI/2025/06/088242 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of patala kshar siddha til tail uttarbasti with urethral dilation in the management of urethral stricture w.s.r mutraghata. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of patala kshar siddha til tail uttarbasti with urethral dilation in the management of urethral stricture w.s.r. mutraghata |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRushikesh Haribhau Jadhav |
| Designation |
PG Scholar |
| Affiliation |
Matoshri Asarabai Darade Ayurved college Babhulgaon Yeola |
| Address |
Matoshri Asarabai Darade Ayurved hospital OPD NO 04/05 Shalya OPD ground floor Matoshri Asarabai Darade Ayurved college SND campus Babhulgaon Tal- YEOLA, Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
7350724538 |
| Fax |
|
| Email |
rushikeshjadhav6296@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPadma Gangurde |
| Designation |
Asso.Prof .MS shalyatantra Department |
| Affiliation |
Matoshri Asarabai Darade Ayurved college Babhulgaon Yeola |
| Address |
Matoshri Asarabai Darade Ayurved hospital OPD NO 04/05 Shalya OPD ground floor Matoshri Asarabai Darade Ayurved college SND campus Babhulgaon Tal- YEOLA, Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
9970553753 |
| Fax |
|
| Email |
padmagangurde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rushikesh Haribhau Jadhav |
| Designation |
PG Scholar |
| Affiliation |
Matoshri Asarabai Darade Ayurved college Babhulgaon Yeola |
| Address |
Matoshri Asarabai Darade Ayurved hospital OPD NO 04/05 Shalya OPD ground floor Matoshri Asarabai Darade Ayurved college SND campus Babhulgaon Tal- YEOLA, Dist- Nashik
Nil
Nashik
MAHARASHTRA
423401
India |
| Phone |
07350724538 |
| Fax |
|
| Email |
rushikeshjadhav6296@gmail.com |
|
|
Source of Monetary or Material Support
|
| Matoshri Asarabai Darade Ayurved college and Matoshri Asarabai Darade Ayurved hospital Babhulgaon, Tal Yeola Dist-
Nashik Maharashtra, India 423401 |
|
|
Primary Sponsor
|
| Name |
Matoshri Asarabai Darade Ayurved college |
| Address |
Matoshri Asarabai Darade Ayurved college and Matoshri Asarabai Darade hospital, Department of shalyatantra, Ground floor,OPD no 4-5,SND Campus, Babhulgaon, Yeola-423401 |
| 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 Rushikesh Haribhau Jadhav |
Matothri Asarabal darade Hospital Yeola |
Matoshri Asarabai Darade Ayurved hospital OPD NO 04/05 Shalya OPD ground floor Matoshri Asarabai Darade Ayurved college SND campus Babhulgaon Tal- YEOLA, Dist- Nashik
Nashik
MAHARASHTRA |
07350724538
rushikeshjadhav6296@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Matoshri Asarabai Darade Ayurved College Babulgaon |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N35||Urethral stricture. Ayurveda Condition: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Sushruth samhita chikitsa 1 shloka 109, Procedure details: The patient should be madea supine position on the OT table. Sterile patala
kshar siddha til tail to be melted over the hot water in a metal vessel.
Penis is held with a sterile gauze pad & the appropriate numbered Infant
Feeding Tube is then lubricated with 5% Xylocaine jelly and
inserted gently intothe urethra. 20 ml patala kshar siddh Taila to be filled in the
syringe and mounted on the Tube and slowly and steadily Taila instilled.
Syringe removed from Infant Feeding Tube and then slowly tube is removed.)
(1) Medicine Name: Patala kshar siddha til tail, Reference: kaiyadev nighantu 6 shloka 37-38, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Urethral dilation by Nelaton catheter | Wash your hands, using soap and water or antibacterial,hand sanitiser.
Setup your equipment on a clean, easily accessible surface
Open the lox 5% ointment and discard a small amount
Apply lox 5% ointment onto a tissue
Get into a comfortable position. This may be lying on your bed.
Remove the catheter from the packet or clean container. Try not to touch the
catheter tip.
Dip or roll the catheter tip into the lox 5% ointment If lox 5% ointment in a
syringe, then instil directly into the urethral opening of the penis.
Grasp the penis and gently pull it out at a right angle from your body.
Insert the catheter into the urethral opening or meatus. Slide the catheter
further into the urethra. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patients of age group between 18 to 60 years.
Male patients will be selected randomly for the study.
Patients having history of stricture of Urethra with mild to moderate symptoms.
4. Patient well diagnosed after clinical examination, Laboratical & Radiological examination. |
|
| ExclusionCriteria |
| Details |
Impacted Calculus in Urethra & Bladder Neck
Acute Retention of Urine
Patients suffering from any systemic disease
4. Patient sugffering from BPH
|
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Parameters will be noted down before and after treatment.
The patient will be diagnosed based on symptoms of Mutraghata
Explained in Ayurvedic and Modern texts.
1) Weak Stream
2)Dysuria
3) Hesitancy |
Nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nill |
Nill |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2025 |
| 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 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
|
The term Mutraghata is made up of two words i.e.; Mutra (i.e.; urine) and ghata means obstruction of urinary passage. Mutrasang is a disease of Mutravahasrotas (urinary tract), one among the 12 types of Mutraghata (obstructive uropathy) disorders elaborated by Acharya Sushruta closely resembles to Urethral stricture of modern medicine in its signs and symptoms.It becomes narrowing of Lumen due to constriction & fibrosis of tissue which prevent the normal flow of urine, Spraying of stream, Frequency of urine, Incomplete emptying, Dysuria or Anuria & Hesitancy,The modern science has suggested Treatment of Intermittent Dilatation but it may cause false passage, fistula formation & bleeding. The Surgical intervention such as Urethroplasty also carries high risk of recurrences and have their own complications and limitations; Modern science has done lot of research but has failed to provide satisfactory treatment without any complications. Uttarbasti With Medicated Oil ( Patala KShar Siddha Til Taill) Is a Parasurgical procedure is the most effective available treatment in Ayurveda for the diseases of Mutravaha Strotasa, |