| CTRI Number |
CTRI/2019/08/020979 [Registered on: 29/08/2019] Trial Registered Prospectively |
| Last Modified On: |
26/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Clinical evaluation of Siddha drug Velli parpam for prostatomegaly(Enlarge prostate) |
|
Scientific Title of Study
|
Phase II non-randomized open clinical evaluation of Siddha drug VELLI PARPAM for PITHA MOOTHIRA KIRICHARAM (Benign prostate hypertrophy) in Male between 40 to 80 age group attending OPD at AAGHIM attached with GSMC |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr E VIVEKANANDHAN |
| Designation |
PG scholar |
| Affiliation |
Govt Siddha Medical College |
| Address |
Post graduate Department of General Medicine
Govt Siddha Medical College
6 anna arch road
NSK nager
Arumbakkam
Chennai
Post graduate Department of General Medicine
Govt Siddha Medical College
6 anna arch road
NSK nager
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9865598155 |
| Fax |
|
| Email |
vivekanandhan.bsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Anbu |
| Designation |
HOD and Professor |
| Affiliation |
Govt Siddha Medical College |
| Address |
Post graduate Department of General Medicine
Govt Siddha Medical College
6 anna arch road
NSK nager
Arumbakkam
Chennai
Post graduate Department of General Medicine
Govt Siddha Medical College
6 anna arch road
NSK nager
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E VIVEKANANDHAN |
| Designation |
PG scholar |
| Affiliation |
Govt Siddha Medical College |
| Address |
Post graduate Department of General Medicine
Govt Siddha Medical College
6 anna arch road
NSK nager
Arumbakkam
Chennai
Post graduate Department of General Medicine
Govt Siddha Medical College
6 anna arch road
NSK nager
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9865598155 |
| Fax |
|
| Email |
vivekanandhan.bsms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Siddha Medical College |
|
|
Primary Sponsor
|
| Name |
Govt Siddha Medical College |
| Address |
6 anna arch road
NSK nagar
Arumbakkam
Chennai
600106 |
| 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 E Vivekanandhan |
Aringar Anna Government Hospital of Indian Medicine |
Room NO 2
Deparment of Pothu Maruthuvam,
Siddha PG wing,
6 anna arch road
NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU |
9865598155
vivekanandhan.bsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Intervention |
VELLI PARPAM |
130mg once a day with ghee for 48 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Isolated BPH symptoms
BPH with lower urinary tract symptoms
PSA (prostate specific antigen) with in the normal limit (<4nm/ml).
USG prostate volume not more than 75 cc ( stage I – 25 cc to 50 cc and stage II – 50 cc to 75 cc) |
|
| ExclusionCriteria |
| Details |
Age < 40 and > 80 yrs male
Acute urinary retention
CA prostate
Acute and chronic renal failure
Diabetic nephropathy
Post TURP states
Stricture urethra
Urinary bladder calculus
Any severe life threatening illness
Nephrotic and nephritic syndrome
PSA more than 4 nm/ml [5].
USG Prostate volume more than 80CC
Acute pyelonephritis
Obstructive uropathy
Prostatitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduced in clinical symptoms using IPSS assessing scale
|
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Monitoring the reduction in the size of the gland from stage II to stage I and from stage I to normal using ultrasonography |
48 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/09/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Non randomized open clinical trial to study safety and efficacy of siddha drug VELLI PARPAM. The drug is given 130 mg once a day for 48 days. Clinical trial will be started after completion of preclinical and toxicological study. the drug VELLI PARPAM mentioned in siddhar kai kanda marunthu written by Balaramiya. During the trial all the study related data will be recorded and documented. |