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CTRI Number  CTRI/2025/06/088484 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management in Benign Prostatic Hyperplasia 
Scientific Title of Study   A CONTROLLED CLINICAL STUDY OF USIRADYA TAILAM UTTARBASTI IN THE MANAGEMENT OF MUTRAGHATA OPEN PARENTHESIS BPH CLOSE PARENTHESIS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kokku Lakshmi Manogna 
Designation  Post Graduate Scholar 
Affiliation  S.V Ayurvedic College and Hospital 
Address  Room no.41, second floor, Department of Shalya tantra S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517507
India 
Phone  8074329023  
Fax    
Email  klakshmimanogna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srinivasa Kumar Kadarisetti 
Designation  Vice principal 
Affiliation  S.V Ayurvedic College and Hospital 
Address  Department of Shalya tantra S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9490084466  
Fax    
Email  viceprincipalsvayc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Srinivasa Kumar Kadarisetti 
Designation  Vice principal 
Affiliation  S.V Ayurvedic College and Hospital 
Address  Department of Shalya tantra S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9490084466  
Fax    
Email  viceprincipalsvayc@gmail.com  
 
Source of Monetary or Material Support  
S.V.Ayurvedic College and Hospital, Tirupati, Andhra Pradesh, 517507 
 
Primary Sponsor  
Name  S.V. Ayurvedic College and Hospital 
Address  S.V. Ayurvedic College and Hospital, Tirupati, Andhra Pradesh, 517507 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kokku Lakshmi Manogna  S.V. Ayurvedic College and Hospital  Room no.41, second floor, Department of Shalya tantra S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh
Chittoor
ANDHRA PRADESH 
8074329023

klakshmimanogna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe of TTDs S.V. Ayurvedic College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: MUTRAGHATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Reference: Bhaiṣajya Ratnāvalī. Mutraghata chikistaprakarana, Procedure details: Patient is given Uttarvasti on every alternate day for 1 week i.e., for 4 times in a week in the First sitting. • And given the gap for 2 weeks, and adviced to come for 2 nd sitting of uttar vasti )
(1) Medicine Name: USIRADYA TAILAM, Reference: Bhaiṣajya Ratnāvalī, Mutraghata chikista prakaranam sloka number 43 to 48., Route: Urethral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 1 Months
2Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Reference: Bhaiṣajya Ratnāvalī. Mutraghata chikistaprakarana, Procedure details: Procedure details: Patient is given Uttarvasti on every alternate day for 1 week i.e., for 4 times in a week in the First sitting. • And given the gap for 2 weeks, and adviced to come for 2 nd sitting of uttar vasti )
(1) Medicine Name: Procedure Reference: Reference: Bhaiṣajya Ratnāvalī. Mutraghata chikistaprakarana, Reference: Sahasrayogam, Route: Urethral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 1 Months
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  1. Patient diagnosis confirmed by USG.
2. Patients having the sign and symptoms of mutraghata BPH 
 
ExclusionCriteria 
Details  1.Age below 45 years.
2.Patients suffering from malignancy, congenital deformities of urogenital tract or any other
pelvic pathology.
3.Uncontrolled Hypertension, Diabetic Mellitus.
4.Urogenital tuberculosis.
5.Paralysis
 
 
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   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical efficacy of Usiradya taila Uttarbasti in reducing the size of the prostate and also reducing the post void residual urine in Benign Prostatic
Hyperplasia. 
DURATION 1 Month
Patient is given Uttarvasti on every alternate day for 1 week for 4 times in a
week in the First sitting.
And given the gap for 2 weeks, and adviced to come for 2 nd sitting of uttar
vasti
Investigation and Assesment is done before treatment and after 2 sittings. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the clinical efficacy of Dhanvatara tailam Uttara basti in reducing the size of the prostate & also reducing the post void residual urine in Benign Prostatic Hyperplasia.
To Compare the efficacies of Usiradya taila Uttarbasti & Dhanvantara tailam Uttar
basti.  
DURATION 1 Month
Patient is given Uttarvasti on every alternate day for 1 week for 4 times in a week in the First sitting.
And given the gap for 2 weeks, & adviced to come for 2 nd sitting of uttar
vasti .
Investigation & assesment is done before treatment & after 2 sittings. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/06/2025 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [klakshmimanogna@gmail.com].

  6. For how long will this data be available start date provided 25-12-2026 and end date provided 31-12-2100?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

The Vatashtheela Mutraghata reflects the symptoms of urine retention, incomplete voiding, dribbling, hesitancy, dysuria, straining during urination etc. These are feature of Lower Urinary Tract Symptoms and can be co–related with Benign Prostatic Hyperplasia in modern parlance. Being prostatic hyperplasia is one of the most prevalent obstructive uropathy of advanced age group people above the incidence has been estimated that 5-10% of men at their age of 40 have Prostatic enlargement & 80% by their age of 80 have evidence of BPH. Clinical features of BPH are hesitancy, dysuria, frequency, urgency, haematuria, pain, retention of urine renal failure, prostatism stream of urine, straining during micturition etc. and often features of acute or chronic retention of urine and uraemia also occurs during progression of disease.

Much advancement both technical and surgical nature have come into existence but still satisfactory treatment of the problemis not found in the modern surgery and urology. The methods like TURP (Trans Urethral Resection of Prostate), TUNA (Trans Urethral Needle Ablation), TUMT (Trans Urethral Microwave Thermotherapy), High-intensity focused ultrasound, TUE(Trans Urethral Electro vaporization, water induced thermotherapy and prostatic stent insertion are in practice but still not comprehensive.

In Ayurveda elaborated description regarding the management of Astheela is found across the samhitas and later works of medieval and modern period of Ayurveda. As discussed earlier the main cause for formation of the disease is Vatadosha, which is either in vridhiavastha or in avrutaavastha, Other contributory doshas are kapha and pitta.

The major chikista sutra formulated for these conditions includes the measures of pacifying Vata like Avagahaswedam, Uttaravasti and other procedures causing the Vatanulomanam. There are many drugs and compounds known to have good effect on Prosate and its pathology.

 Benign Prostatic Hyperplasia is a condition which left untreated may lead to acute urinary retention, urinary tract infections, renal failure in due course of time. In modern system of medicines, Benign Prostatic Hyperplasia is managed with both conservative and surgical treatment modalities, but they are too expensive. The surgical correction also has potential complications including stricture of urethra, incontinence of urine. In Ayurveda, the management of Benign Prostatic Hyperplasia is done by adopting the principles of mutrakrcchra and mutraghata chikitsa,mutravegadharanajanya vikara cikitsa and granthi cikitsa which include avapidaka snehapana, vasti, ksara prayoga.

Thus the present study is entilted as  A CLINICAL EVALUATION OF USHEERADYA TAILAM UTTARBASTI THE MANAGEMENT OF MUTRAGHATA (BPH)


 
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