A CLINICO-COMPARATIVE STUDY OF VARUN TAILA UTTARBASTI WITH AND WITHOUT SNEHAPANA IN THE MANAGEMENT OF MUTRAKRUCCHRA W.S.R. TO URETHRAL STRICTURE -An open-label randomized comparative clinical trial.

A CLINICO-COMPARATIVE STUDY OF VARUN TAILA UTTARBASTI WITH AND WITHOUT SNEHAPANA IN THE MANAGEMENT OF MUTRAKRUCCHRA W.S.R. TO URETHRAL STRICTURE -An open-label randomized comparative clinical trial

INTRODUCTION:

·       Urethra, a tubular passage, is the organ of body which carries urine and seminal fluid in males and only urine in females.

·       Urethral stricture is a narrowing of the urethra due to scar tissue, which leads to obstructive voiding dysfunction with potentially serious consequences for the entire urinary tract.

· The consequences of this obstruction can extremely impair the patient’s quality of life by causing micturition disturbances and resulting in loss of renal functions.

· Urethral strictures are more common in men because their urethra is longer than those in women. Thus, men’s urethra is more susceptible to disease or injury.

·       In classical ayurvedic texts, the disease, in which patient feels difficulty in micturition is consider as Mutrakrucchra.

WHY THIS TOPIC SELECTED?

*·*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.

·    In Ayurveda Mutrakrucchra caused by vitiated Vata dosa especially with its Ruksha Guna; hence Treatment of Vata dosa with Snigdha Guna dominant Dravya can reduce it.

·       Taila considered best among Vata pacifying Dravya and it is one of the Uttama Sneha.

There is a reference that in Mutrakrucchra treatment should be planned according to  Vatasthan and for Vatasthan - Basti is a choice of treatment hence Uttarbasti is selected for Mutrakrucchra.

Acharya Charak also mentioned Uttarbasti and Snehapana in the treatment plan of Vataja Mutrakrucchra.

·       In Uttarbasti, Drug reduce the fibrosis in stricture part of urethra. In Snehapana, Drug reduce the Sanga from Mutravaha Srotasa, particularly at the urethra. As the Mutravaha Srotasa become free from vitiated Vata, considering all the views Varun Taila for Uttarbasti and Shwadamstradi Ghrita for Snehapana has been selected for the treatment in the patients of Mutrakrucchra.

NEED OF PRESENT STUDY:

·       Urethral stricture is common urological problem of people due to lack of any kind of successful western medication there is intense and persistent scope to find out a simple medicine for relieving in the symptoms without any adverse effect on the urethra or urogenital tract.

·       According to above keeping in the view Varun Taila for Uttarbasti and Shwadamstradi Ghrita for Snehapana has been selected for the treatment in the patients of Mutrakrucchra (Urethral Stricture)

RESEARCH QUESTION: ·       Whether there is any significant difference between Varun Taila Uttarbasti with Snehapana and without Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture?

AIM:

• To assess the effect of Varun Taila Uttarbasti with Snehapana and without Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture

OBJECTIVES:

• To evaluate the efficacy of Varun Taila Uttarbasti with Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture

• To evaluate the efficacy of Varun Taila Uttarbasti without Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture

DIAGNOSTIC CRITERIA:

• Sign and Symptoms of Mutrakrucchra (Urethral Stricture)

• Uroflowmetry

• RGU (Retrograde Urethrogram)

• USG-KUB if needed

STUDY DESIGN:

• Study Type : Open label randomized comparative clinical trial

• No. of Groups : 2 (10 patients in each group)

• Sample Size : 20 patients

• Location of study : Study will be conducted at Government Akhandanand Ayurved Hospital and Maniben Ayurved Hospital

DETAILS OF INTERVENTIONS:

● Group A: Shwadamstradi Ghrita Snehapana followed by Varun Taila Uttarbasti in the management of Mutrakrucchra w.s.r. Urethral Stricture

● Group B: Varun Taila Uttarbasti without Snehapana in the management of Mutrakrucchra w.s.r. Urethral Stricture

OBJECTIVE CRITERIA of Assessment (Before & After treatment):

• Uroflowmetry

• RGU ( Retrograde Urethrogram)

WITHDRAWL CRITERIA:

After the scheduled course, medicines will be withdrawn with proper consultation and future follow-up will be maintained

During the trial period, if any moderate to severe complications found, medication will be stopped

REPORTING ADR:

Adverse Drug Reaction (ADR), if observed will be registered and reported to Peripheral Pharmacovigilance Centre (PPvC), GAAC, Ahmedabad

DECLARATION:

The study will be completed in the stipulated time limit.

The work will be carried out after getting clearance from the institutional ethics committee.

The data related to the identification of the patient will be kept confidential.

The clinical data obtained will be summarized at the end of the study