| CTRI Number |
CTRI/2022/07/044050 [Registered on: 15/07/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Trail of Venkara Parpam for Neerkattu Vatham (Benign Prostatic Hyperplasia) |
|
Scientific Title of Study
|
An Open Non Randomized Single Arm, Single Centric Clinical Trial To Determine The Effectiveness Of Venkara Parpam In The Management Of Neerkattu Vatham (Benign Prostatic Hyperplasia) Among Out Patients Attending Ayothidoss Pandithar Hospital, National Institute Of Siddha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C Selvalenin |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 1, Department of Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7639164757 |
| Fax |
|
| Email |
leninselva555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Lakshmikantham MDS PhD |
| Designation |
Associate Professor & HoD (i/c) |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444466880 |
| Fax |
|
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Lakshmikantham MDS PhD |
| Designation |
Associate Professor & HoD (i/c) |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai
TAMIL NADU
600047
India |
| Phone |
9444466880 |
| Fax |
|
| Email |
drlakshmiramaswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Tambaram Sanatorium,
Chennai |
| 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 C Selvalenin |
Ayothidoss Pandithar Hospital |
Room No 1, Department of Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai
Kancheepuram
TAMIL NADU |
7639164757
leninselva555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, National Institute of Siddha |
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 |
Venkara Parpam |
500 mg with Tender coconut water BD After food for 48 days |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients having symptoms such as delay in initiating micturition,hesitancy,weak
urinary stream,straining to void,sensation of incomplete emptying and terminal
dribbling.
2. Increased residual urine volume
3. Nocturia ,urgency,bladder pain, dysuria
4. PSA (Prostate specific antigen) less than 10ng/ml.
5. USG prostate volume not more than 80 cc |
|
| ExclusionCriteria |
| Details |
KNOWN CASE OF
CA prostate
Urinary bladder calculus
Acute and chronic renal failure
Diabetic nephropathy
Stricture urethra
PSA more than 10 ng/ml
USG prostate volume more than 80ml |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment by clinical symptoms using
IPSS assessing scale. |
Screening - 2 months
Enrolment - 2 months
Drug - 4 months
Data analysis - 2 months
Follow up - 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the changes in PSA Level
2. To assess the reduction in size of the prostrate gland and prostrate volume and
residual urine volume using ultrasound scan. |
Screening - 2 months
Enrolment - 2 months
Drug - 4 months
Data analysis - 2 months
Follow up - 2 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/07/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IntroductionThis is an open non randomized single arm, single centric clinical trial to evaluate the effectiveness of venkara parpam in the management of neerkattu vatham (benign prostatic hyperplasia) patients through International prostate symptom score(IPSS),Prostate specific antigen(PSA) and Ulterasound sonography(USG) before andafter treatment. Benign Prostatic Hyperplasia is a pathologic process that contributes to the development of lower urinary tract symptoms in men. Such symptoms, arising from lower urinary tract dysfunction, are further subdivided into voiding symptoms and storage symptoms. BPH is one of the common diseases of the male community. summarizing data from five prior studies showed that no men younger than 30 had evidence of BPH. The prevalence of BPH accounts nearly 8% of men aged between 45 to 50 years, around 50% affected men aged those were between 50-80 years and in men above 80 years of age the prevalence rate is almost 80%. An estimated 50% of men demonstrate histopathologic BPH changes by age 60 years.. So my aim is to treat the Neerkattu vatham(Benign Prostatic Hyperplasia) with the Siddha classical drug VENKARA PARPAM. MATERIALS AND METHODS: A Total of 25 diagnosed patients of Neerkattu vatham(Benign Prostatic Hyperplasia) within the age limit of 50 - 80 years willing to participate in the study ,by signing the consent form will be enrolled in the study. CA Prostate,urinary bladder calculus,acute and chronic renal failure,diabetic nephropathy,stricture urethra will be excluded. Assessment in improvement is done through International prostate symptom score(IPSS),Prostate specific antigen(PSA) and Ulterasound sonography(USG) before and after treatment. RESULTS AND DISCUSSION:
The result will be statistically analyzed
KEYWORDS: Neerkattu vatham,Benign Prostatic Hyperplasia,Venkara Parpam |