| CTRI Number |
CTRI/2025/03/083739 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An ayurvedic management of chronic prostatitis |
|
Scientific Title of Study
|
A study on management of chronic prostatitis by basti therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Kumar Yadav |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty Of Ayurveda
IMS BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9651344519 |
| Fax |
|
| Email |
drrohitimsbhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar Dwivedi |
| Designation |
Assistant professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty Of Ayurveda
IMS BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451050860 |
| Fax |
|
| Email |
drarunbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Kumar Yadav |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty Of Ayurveda
IMS BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9651344519 |
| Fax |
|
| Email |
drrohitimsbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital Faculty of Ayurveda IMS BHU Varanasi India 221005 |
|
|
Primary Sponsor
|
| Name |
Department of Shalya Tantra |
| Address |
Faculty Of Ayurveda
IMS BHU
Varanasi
India 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rohit Kumar Yadav |
Sir Sunderlal Hospital |
Indian Medicine Wing
Department of Shalya Tantra
Sir Sunderlal hospital
IMS BHU
Varanasi
Faculty of Ayurveda
IMS BHU
Varanasi
UTTAR PRADESH |
9651344519
drrohitimsbhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Medical Sciences BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N411||Chronic prostatitis. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Basti | (Procedure Reference: Ashtang Hridaya sutra 19, Procedure details: Kala Basti includes anuvasanabasti for the first day followed by kasayabasti alternating with Snehabasti ending with 3 Anuvasanabasti - a total of 10 anuvasanbasti and 5 kasayabasti )
(1) Medicine Name: Saptaprasritik Basti , Reference: Charaka Siddhi Sthana 8 th chapter, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 180(ml), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | bastikarma, बस्तिकर्म | (Procedure Reference: Ashtang Hridaya sutra 19, Procedure details: Kala Basti includes anuvasanabasti for the first day followed by kasayabasti alternating with Snehabasti ending with 3 Anuvasanabasti - a total of 10 anuvasanbasti and 5 kasayabasti )
(1) Medicine Name: Shilodhbhidadi Taila , Reference: Bhesajya Ratnavali Mutroghat Rogadhikar 49, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Age between 20-40yrs
All cases of chronic prostatitis /Chronic pelvic pain syndrome
Diagnosed cases of sexual dysfunction i.e. ejaculatory pain, erectile dysfunction, premature ejaculation.
Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Acute prostatitis
Prostatic abscess
Pyuria
Chronic HTN
T2DM
Known cases of Systemic disease like Tuberculosis, HepatitisB, HIV, Hepatitis C, Cardiac diseases,
Uncontrolled DM
Neurogenic bladder
Carcinoma of prostate
Subjects with ARF&CRF
Subjects with Veneral diseases
Urethral stricture
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Disease specific subjective parameters based on NIH CPSI score and IIEF 5 Scoring.
Objective parameters based on radiological findings (USG,TRUS, Multiparametric MRI) and biochemical analysis(Serum PSA and Serum Testosterone) inflammation of prostate will be assessed. |
Basti will be administered for a period of 15 days followed by follow up at 15 days , 1 month and 2 months . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in signs and symptoms of chronic prostatitis
|
For a period of 3 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
On the basis of previous data and disease prevalence a total sample size of 30 patients has calculated after statistical analysis.Patients with signs and symptoms of chronic prostatitis will be selected from OPD/IPD of department of Shalya Tantra and included in a single interventional group. Complete evaluation will be done by clinical examination, hematological, biochemical, radiological, urine analysis and uroflowmetry studies. Patients wil be treated with Kala Basti for a period of 15 days; 10 anuvasana basti with shilodhbhidadi Taila and 5 kashaya basti with saptaprasratik Kashaya. Before and after completion of therapy patients will be assessed by subjective (NIH CPSI scoring and IIEF 5 scoring ) and objective parameters including radiological findings (USG,TRUS, Multiparametric MRI) and biochemical analysis(Serum PSA and Serum Testosterone) for inflammation of prostate .. The biochemical , biophysical , biosafety , toxicity study and therapeutics of saptaprasritik basti and shilodhbhidadi taila will be studied.
|