| CTRI Number |
CTRI/2025/02/080616 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the Effect of Haritakyadi Kwath and Yavakshar in Men (40-80 Years) with Benign Prostatic Hyperplasia |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial to Assess The Efficacy of Haritakyadi Kwath and Yavakshar in Management of Vatastheela W.S.R to 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 Khushal Chouhan |
| Designation |
MS Shalyatantra Scholar |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD No 18 Department of Shalyatantra
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata Mandir Patur District Akola 444501 Maharashtra India
Akola
MAHARASHTRA
444501
India |
| Phone |
7568658442 |
| Fax |
|
| Email |
khushal.chouhan93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Belorkar |
| Designation |
MS Shalyatantra Associate professor |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD No 18 Department of Shalyatantra
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata Mandir Patur District Akola 444501 Maharashtra India
Akola
MAHARASHTRA
444501
India |
| Phone |
7972681655 |
| Fax |
|
| Email |
Ganeshbelorkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Belorkar |
| Designation |
MS Shalyatantra Associate professor |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD No 18 Department of Shalyatantra
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata Mandir Patur District Akola 444501 Maharashtra India
MAHARASHTRA
444501
India |
| Phone |
7972681655 |
| Fax |
|
| Email |
Ganeshbelorkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata Mandir Patur Dist Akola 444501 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya, Near Renuka Mata Mandir Patur Dist Akola 444501 Maharashtra India |
| 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 Khushal Chouhan |
Dr VJD Gramin Ayurved Mahavidyalaya |
OPD No 18 Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata Mandir Patur Dist Akola
Akola
MAHARASHTRA |
7568658442
khushal.chouhan93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Dr VJD Gramin Ayurved Mahavidyalaya Patur Akola |
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: Haritakyadi kwath , Reference: Bhaisjya Ratnavali 34/27, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -(2) Medicine Name: Yavakshar , Reference: Bhaisjya Ratnavali 34/41, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: Tamsulosin Hcl , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: .4(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Patients presenting with classical
signs and symptoms of
Benign Prostatic
Hyperplasia
|
|
| ExclusionCriteria |
| Details |
CA Prostate
Urethral stricture
Benign tumor of urethra
Malignant tumor of urethra
Urethral injury
Urethral calculi
Age above 80 years and
below 40 years
Patients with systemic diseases
like uncontrolled Hypertension
(more than 150/90 mm Hg) and
uncontrolled Diabetes mellitus
(RBS more than 180 mg/dl),
Tuberculosis, STD, HIV, HBSAg |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective criteria
Quality of life due to urinary symptoms
International prostate symptoms score IPSS
Objective criteria
Prostate size (volume) by USG
Residual urine volume by USG
Urine flow rate |
Before treatment and after treatment and follow up at 15 and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of Vatastheela and Quality of life due to urinary symptoms |
18 months |
|
|
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)
|
01/03/2025 |
| 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="6"
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
|
Benign Prostatic Hyperplasia (BPH), is a common condition among aging males, characterized by prostate gland enlargement leading to lower urinary tract symptoms. It expresses both the obstruction and the irritability of the urinary system. Vatashtheela is a hard, elevated, mobile swelling. It is one of the thirteen types of Mootraghata. Vatashtheela reflects the symptomsimilar to the Lower Urinary Tract Symptoms (LUTS) and may be corelated with Benign Prostatic Hyperplasia (BPH). Vatashtheela is a condition of obstructive uropathy which may present with either partial or complete retention of urine. The prevalence of Benign Prostatic Hyperplasia increases after the age of 40 years, autopsy studies have observed a histological prevalence of 8%, 50%, and 80% in the 4th, 6th and 9th decade of life, respectively. Since Benign Prostatic Hyperplasia is not a rapid progressive disease so the management of Benign Prostatic Hyperplasia can be achieved by adapting conservative measure and lastly surgical intervention as it may lead to many complications like postoperative morbidity, impotence, retrograde ejaculation etc. Apart from that a cumulative probability for reoperation has been estimated up to 15% of operated cases within 8-10 years. Although administration of conservative modern treatment i.e. hormone therapy has good advantages but has side effects like loss of libido, Impotence, gynecomastia etc. Hence, Ayurveda may be more effective as well as safe for conservative management of B.P.H.
|