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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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 | 2 | Comparator Arm | Procedure | - | 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [klakshmimanogna@gmail.com].
- 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.
- 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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