| CTRI Number |
CTRI/2024/07/070823 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic treatment for Benign Prostatic Hyperplasia with Mustadi Gana Kwatha and Swadamstradi Taila |
|
Scientific Title of Study
|
A Phytochemical In Silico and Clinical Study of Mustadi Gana Kwatha and Swadamstradi Taila in the management of Benign Prostatic Hyperplasia |
| 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 Saradhi R |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Dept of Shalya Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7034466460 |
| Fax |
|
| Email |
saradhi1002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar Dwivedi |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Dept of Shalya Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9161499774 |
| Fax |
|
| Email |
drarunbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Kumar Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Pharmaceutical Engineering IT Banaras Hindu university
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7348476308 |
| Fax |
|
| Email |
skmishra.phe@itbhu.ac.in |
|
|
Source of Monetary or Material Support
|
| OPD of Department of Shalya Tantra Sir Sunderlal Hospital Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi |
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda Institute of Medical SciencesBanaras Hindu University |
| Address |
Dept of Shalya Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi 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 Saradhi R |
Sir Sunderlal Hospital |
OPD no 12 14 16A and NRC Dept of Shalya Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH |
7034466460
saradhi1002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, IMS, BHU |
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: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mustadi Gana Kwatha, Reference: Susruta Samhita Uttara Tantram Mutrakrichra Pratisheda , Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 120(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Kashaya basti with Mustadi gana kashaya in empty stomach | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: swadamstradi taialm, Reference: Susruta Samhita Uttara Tantram Mutrakrichra Pratisheda , Route: Rectal, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 10 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
diagnosed cases of BPH, without acute retention of urine
all grades of BPH without acute retention of urine |
|
| ExclusionCriteria |
| Details |
Patients with bladder neck stenosis acute urinary retention known case of systemic diseases like TB Hepatitis B HIV Hepatitis C Cardiac diseases uncontrolled DM urethral stricture Neurogenic bladder ARF and CRF veneral diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Disease specific subjective parameters based on IPSS score
objective parameters like weight of prostate and PVRU by USG whole abdomen with prostate and PVRU
|
Basti will be administered for a period of 15 days followed by follow up every 4 weeks for a period of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of BPH |
for a period of 3months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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="1"
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 - NO
|
|
Brief Summary
|
On the basis of previous data and disease prevalence a total sample size of 25 has calculated after statistical analysis.Patients with signs and symptoms of BPH 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 will be treated with Kala Basti for a period of 15 days;10 anuvasana basti with Swadamstradi Taila and 5 kashaya basti with Mustadi Gana Kashaya. After completion of therapy it will be assessed by subjective and objective parameters including urine flowrate(UFR), Post Voidal Residual Urine(PVRU) and size of prostate by USG. Statistical analysis, Phytochemical ,In Silico study will be conducted on a computer through computational simulations. The biochemical, biophysical, biosaftey ,toxicity study and theraputics of Mustadi Gana Kashaya and Swadamstardi Taila will be studied. |