| CTRI Number |
CTRI/2024/05/068156 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial on vedigara silasathu parpam in the management of Azhal neerchurukku (Urinary tract infection) among patients attending OPD and IPD of Government Siddha Medical College and Hospital, Palayamkottai |
|
Scientific Title of Study
|
A Prospective open labelled single arm non randomized single centric phase II clinical trial on vedigara silasathu parpam in the management of Azhal neerchurukku (Urinary tract infection) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYADHARSHINI R |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital palayamkottai |
| Address |
OP number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli, India
Government Siddha Medical College and Hospital,
Thiruvananthapuram main road,
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9500892607 |
| Fax |
|
| Email |
Priyadharshinivr01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subash chandran |
| Designation |
Reader |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital
Thiruvananthapuram main road
Palayamkottai
Tirunelveli 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9345600723 |
| Fax |
|
| Email |
Siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T Komalavalli |
| Designation |
Head of the department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital Tiruvananthapuram main road Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd and ipd facilities and central library of government siddha medical college and hospital,Tiruvananthapuram main road, Palayamkottai, Tirunelveli -627002,Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
PG department of Pothu Maruthuvam Government Siddha Medical College and Hospital
Thiruvananthapuram road
Palayamkottai
Tirunelveli-627002,Tamilnadu, India |
| 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 R Priyadharshini |
Government Siddha Medical College and Hospital |
OP number 10, PG department of Pothu Maruthuvam Government Siddha Medical College and Hospital,Tiruvananthapuram main road,Palayamkottai,India
Tirunelveli
TAMIL NADU |
9500892607
Priyadharshinivr01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Government Siddha Medical College and Hospital, Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
VEDIGARA SILASATHU PARPAM |
DOSAGE: 130 mgs Twice a day orally for 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms with burning micturition/ dysuria, fever with chills (less than 1040 F), frequency of micturition, hematuria, pain over the suprapubic region, and low back pain. (Above all any three symptoms present they will be included in clinical trial).
2.Patients who are willing to go for urine culture & undergo routine blood investigation.
3.Patients with urine culture significant for bacteria or fungus (eg.Escherichiacoli, klebsiella, enterococci, proteusmirablis staphy lococci etc……)
|
|
| ExclusionCriteria |
| Details |
1.Pregnant
2.Lactating mother
3.Recent malignancy or radiation therapy
4.Patients considered unreliable by the investigator(e.g., drug addiction, alcohol abuse)
5.H/O Sexually transmitted disease
6.Renal calculus
7.Hydronephrosis
8.Medical renal disease
9.Hyper pyrexia above 104 F.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be aimed at reducing the symptoms of Azhal neerchurukku and to evaluate the therapeutic efficacy of clinical trial drug (vedigara silasathu parpam) |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various aspects of Azhal neerchurukku in Siddha literatures
2.To evaluate physico chemical ,phytochemical and biochemical characters of vedigara silasathu parpam.
3.To evaluate safety profile for assessing acute and subacute toxicity of trial drug vedigara silasathu parpam.
4.To study anti microbial activity of vedigara silasathu parpam against various pathogenic microorganism .
5.To evaluate pharmacological analysis of vedigara silasathu parpam.
6.Study about the prevalence of Azhal neerchurukku in relation between diet and lifestyle
7.To evaluate Siddha parameters(including envagai thervu) changes in Azhal neerchurukku during the study period
8.To evaluate modern parametric changes in Azhal neerchurukku
9.To evaluate the efficacy of Vedigara silasathu parpam on Azhal neerchurukku by the Bio statistical analysis. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/06/2024 |
| 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="0"
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
|
This is A Prospective, open labelled, single arm,non randomized, single centric,phase II clinical trail on vedigara silasathu parpam inthe management of Azhal neerchurukku ( Urinary tract infection). The trial drug Vedigara silasathu parpam is freshly prepared and administered at a dosage of 130 mgs (Twice a day orally) with Ghee ( pasu nei) as adjuvant for 10 days for 40 known Urinary tract infective patients (20 OP & 20 IP patients). The primary outcome will be to determine the therapeutic efficacy of vedigara silasathu parpam in management of Azhal neerchurukku (UTI). The secondary outcome will be to collect various aspects of Azhal neer churukku in Siddha literatures, to evaluate physico chemical,phyto chemical and bio chemical characters of Vedigara silasathu parpam, to evaluate safety profile for assessing acute and sub-acute toxicity of trial drug – Vedigara silasathu parpam, to study antimicrobial activity of Vedigara silasathu parpam against various pathogenic micro organism, to evaluate pharmacological analysis of vedigara silasathuparpam, study about the prevalence of Azhal neerchurukku in relation between diet and life style, to evaluate siddha parameters (including Envagai thervu) changes in Azhal neerchurukku during the study period, to evaluate modern parametric changes in Azhal neerchurukku, to evaluate the efficacy of vedigara silasathu parpam on Azhal neerchurukku by the Bio statistical analysis.
|