| CTRI Number |
CTRI/2019/09/021386 [Registered on: 23/09/2019] Trial Registered Prospectively |
| Last Modified On: |
12/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Prostate enlargement |
|
Scientific Title of Study
|
An Open Label, Single Arm, Multi-center, Prospective Clinical study to evaluate Efficacy and Safety of WEL/ARNP01 Capsule in patients suffering from Benign Prostate Hyperplasia (BPH) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AYRN/BPH/WLX/2019, Version 1.0, 17th Jul 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay P Ukhalkar |
| Designation |
Professor and HOD |
| Affiliation |
Govt. Ayurved College, Vazirabad, Nanded |
| Address |
Department of Shalya-Tantra, Ground Floor, Room No. 4 Govt. Ayurved College, Vazirabad, Nanded, Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422171987 |
| Fax |
|
| Email |
ukhalkarvp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Welex Laboratories Pvt. Ltd. 1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -400013 |
|
|
Primary Sponsor
|
| Name |
Welex Laboratories Pvt Ltd |
| Address |
1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -400013 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay P Ukhalkar |
Govt. Ayurved College |
Department of Shalya-Tantra Ground Floor, Room No. 4 Govt. Ayurved College, Vazirabad, Nanded- 431601
Nanded
MAHARASHTRA |
9422171987
ukhalkarvp@gmail.com |
| Dr Kamalakar Gajare |
MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra |
Department of Shalya Tantra, OPD No. 3 Ground Floor MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA |
9850123482
drgajarekv@gmail.com |
| Dr Nagaraj S |
S.D.M. College of Ayurveda |
P.G. Department of Rognidana, Ground Floor, OPD No. 7, S.D.M. College of Ayurveda, Kuthpady Udupi Karnataka 574 118
Udupi
KARNATAKA |
9448408722
cosultantdr@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Clearance committee -Human, Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi |
Approved |
| Institutional Ethics committee, Govt. Ayurved College and Hospital, Vazirabad Nanded |
Approved |
| Institutional Review Board For Research, MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra, Malwadi Hadapsar Pune |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL
Dosage and Treatment duration : NIL |
| Intervention |
WEL/ARNP01 Capsules |
contains Gokshura (Tribulus terrestris), Pashanbhed (Bergenia ligulata), Varun (Crataeva nurvala), Kulthi (Dolichos biflorus), Ushir (Vetiveria zizaniodes), Punarnava (Boerhaavia diffusa), Bala (Sida cordifolia), Anantmool (Hemidesmus indicus), Shatavari (Asparagus racemosus), Kababchini (Piper cubeba).
Dosage and Treatment Duration: 2 Capsules twice daily orally after meal with lukewarm water for 90 days.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1.Subjects medically diagnosed BPH, having a minimum score of 8 on IPSS and Mild to Moderate Prostatomegaly (weight 25-70 gm) on USG study.
2.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form
|
|
| ExclusionCriteria |
| Details |
1.Subjects with clinically significant high PSA levels
2.Pharmaceutical or medical therapy for BPH or other urological symptoms, history of bladder biopsy and or cystoscopy and biopsy within the last 30 days
4.Subjects on bladder-training program, indwelling catheter or practiced self-catheterization
5.Subjects with history of urogenital surgery within the last 6 months;
6.Subjects with history of chronic persistent local pathology (i.e. interstitial cystitis, bladder stones) within the past 30 days
7.Subjects receiving/prescribed anticoagulation therapy;
8.Subjects with severe renal and/or hepatic insufficiency, known genital anatomical deformities, uncontrolled DM and uncontrolled HT, uncontrolled psychiatric disorder, abnormal secondary sexual characteristics and prostatic cancer
9.Subjects with a history of spinal cord injury, chronic alcohol and/or illicit drug abuse
10.Subjects participated in any other clinical trial during last 30 days
11.Any other condition, which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of monthly change in international prostate symptom score (IPSS) over three months period |
Day -7, Day 0, Day 30, Day 60, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of change in prostate size and weight by USG (pre and post treatment)
2. Global assessment for overall change by the subject and investigator at the end of study treatment
3. Tolerability of study drug by assessing ADRs on study completion
4. Assessment of Laboratory parameters, USG and ECG on study completion |
Day -7, Day 0, Day 30, Day 60, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/09/2019 |
| Date of Study Completion (India) |
04/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open label, single
arm, multi-center, prospective clinical study to evaluate efficacy and safety
of WEL/ARNP01 Capsule in patients suffering from Benign Prostate Hyperplasia
(BPH). The study will be conducted at three sites in India. Subjects will be
advised to take 2 WEL/ARNP01 Capsules twice daily orally after meals with water
for 90 days. The primary objective of the study will be to assess monthly change in
international prostate symptom score (IPSS) over three months period. The secondary objectives of
the study will be to assess change in prostate size and weight by USG (pre and
post treatment), global assessment for overall change by the subject and
investigator at the end of study treatment, tolerability of study drug by
assessing ADRs on study completion and to assess laboratory parameters, USG and
ECG on study completion. |