| CTRI Number |
CTRI/2025/05/086366 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
role of Uttarbasti in Mutrakruccha Urethral Stricture |
|
Scientific Title of Study
|
A Clinico Comparative Study Of Shwadamstradi Taila Uttarbasti With And Without Matrabasti In The Management Of Mutrakruccha With Special Reference To Urethral Stricture An Open Label Randomized Comparative 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 |
Pranit R Nachan |
| Designation |
PG Scholar |
| Affiliation |
Government Akhandanand Ayurved College Ahmedabad |
| Address |
Government Akhandanand Ayurved College and Hospital Ahmedabad Department of Shalyatantra OPD 14 Government Akhandanand Ayurved College and Hospital Ahmedabad Ahmadabad GUJARAT 380001 India |
| Phone |
9511650880 |
| Fax |
|
| Email |
pranitnachan4836@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajesh kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Government Akhandanand Ayurved College Ahmedabad |
| Address |
Department of Shalyatantra OPD 14 Government Akhandanand Ayurved College Ahmedabad
Ahmadabad GUJARAT 380001 India |
| Phone |
9408205584 |
| Fax |
|
| Email |
dr.rajeshsharma38@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajesh kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Government Akhandanand Ayurved College Ahmedabad |
| Address |
Department of Shalyatantra OPD 14 Government Akhandanand Ayurved College Ahmedabad
GUJARAT 380001 India |
| Phone |
9408205584 |
| Fax |
|
| Email |
dr.rajeshsharma38@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurved College and Hospital Ahmedabad Gujarat 380001 India |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurved College and Hospital |
| Address |
Department of Shalya Tantra OPD No 14 Government Akhandanand Ayurved College and Hospital Ahmedabad Gujarat 380001 India Ahmedabad GUJARAT 380001 India
Ahmadabad GUJARAT 380001 India |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pranit R Nachan |
Government Akhandanand Ayurved College and Hospital |
Department of Shalyatantra OPD 14 Government Akhandanand Ayurved College and Hospital Ahmadabad GUJARAT |
9511650880
pranitnachan4836@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Akhandanand Ayurved College Ahmedabad |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N359||Urethral stricture, unspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Sushrut uttartantra 59th chapter 17th shloka, Procedure details: Preparation of the patient
Take written informed consent of patient
Patient advised to empty bladder prior to the procedure of Uttarbasti
Local Abhyanga Swedana to be done prior to Uttarbasti
Painting and draping properly
Procedure will be performed in the morning after complete digestion of the previous meal.
INSTRUMENTS
Disposable syringe 20 ml capacity
10 percent betadine solution 2 percent Lignocaine jelly
Sponge holding forceps
Sterile hole sheet Cotton and gauze pads Surgical Gloves Surgical mask and gown
All the instruments to be properly sterilized and the procedure to be conducted in the operation theater under
strict aseptic measures.
DOSE 20 ml
DURATION One time per day for 21 days
means 3 cycle in which one cycle Uttarbasti for 3 days than 4 days gap between two cycles
Instillation of medicated Taila into bladder constitute of Pradhan karma
The patient should made supine position on OT table.
Taila will be made luke warm by keeping it into luke warm water.
The Syringe tip will to be introduced in the Urethra and 20 ml Taila to be pushed.
Penile clamp will be used for better effect. PASCHAT KARMA Patient advised to relax for 30 min in the bed and hot water bag to be given.
Patient advised to take plenty of liquids especially hot water buttermilk barley water through the day) (1) Medicine Name: Shwadamstradi Taila, Reference: Sushrut Uttartantra 59th chapter 19th shloka, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 12 Days | | 2 | Comparator Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः with maatrabasti | (Procedure Reference: Charak Chikitsa 26th chapter 58 shloka, Procedure details: 9 days uttarbasti with 4 days gap and maatrabasti for 12 days continuously) (1) Medicine Name: Shwadamstradi Taila, Reference: Sushruta Uttar Tantra 59 chpter 19th shloka, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 9 Days(2) Medicine Name: Shwadamstradi Taila, Reference: Sushruta Uttar Tantra 59 chpter 19th shloka , Route: Rectal, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 12 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient selected irrespective of their Religion, Cast, Gender without any bars
Age between 18 to 60 years
Controlled case of Diabetes with HbA1C less than 7 percentage and Hypertension with BP less than 150 systolic and 90 diastolic
Patient having sign &symptoms of Mutrakruccha Urethral Stricture fulfilling diagnostic criteria will be included |
|
| ExclusionCriteria |
| Details |
Patient below the age of 18 years or above the age of 60 years
Patient have impacted calculus in the urethra and urinary bladder neck Benign Prostatic Hyperplasia Nephrotic syndrome and Neoplasm of lower urinary tract UTIs Atonic Bladder
Patient with systemic disease like Asthma Epilepsy Autoimmune disorders Multiple Sclerosi Heart Disease
Uncontrolled case of Diabetes with HbA1C more than 7percentage and Hypertension with BP more than 150 systolic and 90 Diastolic
Patient with HIV HBsAg STDs
Patient with malignancy will be excluded |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in patients signs and symptoms like reduced Frequency of micturition and Reduced pain while micturition |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| which procedure is more helpful in relieving the symptoms of mutrakruccha |
2 months |
|
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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)
|
02/06/2025 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Stricture urethra though a rare condition still is a rational and troublesome problem in the international society. There is marked increase in incidence starting at the age of 55 years. Studies have suggested that men appear to be at more risk than that of females as they have longer urethra. Worldwide it is estimated that male urethral strictures have a prevalence of The etiology of urethral strictures is divided into 4 major groups Idiopathic Iatrogenic inflammatory and Post traumatic. Urethral stricture may present in the of range of manifestations from an asymptomatic presentation to severe discomfort secondary to urinary retention .It is common condition resulting in many office appointments emergency room visits and hospital admissions with the estimated rate around 1 to 9 strictures per 1000 people in India. Stricture usually arising from prolonged catheterization radiation BPH prostatic and trans urethral surgery repeated UTI and STD. Approximately 30 percent of urethral strictures are idiopathic and most common causes of urethral stricture today are traumatic or iatrogenic. Iatrogenic urethral trauma usually results from improper or prolonged catheterization and accounts for 32 percent of strictures. Some patients may choose to manage their stricture disease with periodic urethral dilations. The goal is to stretch the scar without producing additional scarring. It may be curative in patients with isolated epithelial strictures means no involvement of corpus spongiosum. Most of the time urethral stricture is seen in elderly population with a marked increase after 55years of age. Urethral stricture disease is still a prevalent problem with an estimated incidence of 0.6 percent in susceptible population. In patients with urethral stricture disease older than 60 years 6.5percent underwent retrograde urethrography RUG studies. Urethral dilation remains a very common outpatient procedure among Medicare beneficiaries. Patients with urethral stricture are considered a vulnerable population as they experienced high rates of UTIs and incontinence as sequelae of the disease. In modern surgery effective therapy has been establish for the condition but more recurrences and complications. The discussion on surgical techniques and diagnostic methods of one of the oldest pathologies known to the urologist is still continuous. Thus the urethral stricture remains a challenging pathology today. Hence there is need to find other treatment option for Urethral stricture. Acharya sushruta mentioned Ghrita and Taila Uttarbasti in management of the Urethral stricture. In Uttarbasti Drug reduce the fibrosis in stricture part of urethra. Matrabasti Drug pacifies the pain particularly at the perineal region as the Mutravaha Srotasa become free from vitiated Vata. By keeping mentioned things at point of convergence shwadamstradi taila Uttarbasti with and without Matrabasti is selected for the management of Mutrakruccha with special reference to urethral stricture. Though there are multi folded treatment modalities exists in western medical science they are having own advantages and disadvantages so there was an intense and persistant scope to find out simple and easily available treatments for relieving painful micturition by increasing constricted urethral lumen diameter without any adverse effect. Uttarabasti a para surgical procedure is the most effective available treatment in Ayurveda for the diseases of Mutravaha Strotas. In Mutrakruccha there is vitiation of Vata especially Apan vayu which is located at Shroni Basti Medhra leads to obstruction of urine outflow due to this Vimargagamana and Marga Avrodhan occurs. Therefore main principle should be to Vatanuloman and Mutrashodhan to return the normal qualities of Apan Vayu. Medicated oil prepared out of Gokshur swarasa Gud Kshir Shunthi which are prepared by Tailapak method.Due to this Sanga gets removed from Mutravaha Strotasa particularly at the urethra leading to increase in size of the lumen which was constricted previously diameter at the site of stricture. As the Mutravaha Strots become free from the vitiated Vata. considering all the views Shwadamstradi taila Uttarbasti with and without Matrabasti has been selected for the management of Mutrakruccha with special reference to Urethral Stricture. |