| CTRI Number |
CTRI/2018/03/012710 [Registered on: 21/03/2018] Trial Registered Prospectively |
| Last Modified On: |
21/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study NERUNJI VER KUDINEER for KALLADAIPPU
[Urolithiasis] |
|
Scientific Title of Study
|
A Prospective Open Labelled Non Randomized Clinical Trial on herbal formulation of NERUNJI VER KUDINEER for the treatment of KALLADAIPPU[Urolithiasis]
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bernath P |
| Designation |
PG Student |
| Affiliation |
Govt Siddha Medical College And Hospital |
| Address |
PG Second year Department of Pothu Maruthuvam
Govt Siddha Medical College And Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486805805 |
| Fax |
|
| Email |
dr.a.bernath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr A Manoharan MD |
| Designation |
Head Of Department Department of Pothu Maruthuvam |
| Affiliation |
Govt Siddha Medical College And Hospital |
| Address |
Head Of Department Department of Pothu Maruthuvam
Govt Siddha Medical College And Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr A Manoharan MD |
| Designation |
Head Of Department Department of Pothu Maruthuvam |
| Affiliation |
Govt Siddha Medical College And Hospital |
| Address |
Head Of Department Department of Pothu Maruthuvam
Govt Siddha Medical College And Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Library Govt Siddha Medical College And Hospital Palayamkottai
OPD and IPD Govt Siddha Medical College And Hospital
Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Dr S Neelavathi MD PhD |
| Address |
Principal Govt Siddha Medical College And Hospital
Palayamkottai
Tirunelveli TAMIL NADU |
| 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 |
| Bernath P |
Govt Siddha Medical College And Hospital |
OPD Room No 10 Department of Pothu Maruthuvam
Govt Siddha Medical College And Hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
9486805805
dr.a.bernath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
KALLADAIPPU, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NERUNJI VER KUDINEER |
100 ML BD FOR 30 DAYS |
| Comparator Agent |
NERUNJI VER KUDINEER |
100 ML BD FOR 30 DAYS |
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Age from 30 years to 60 years Patient With Renal Colicky pain Nausea Vomiting
Haematuria Oliguria Pyuria Dysuria |
|
| ExclusionCriteria |
| Details |
Age Below 30 years and above 60 years Chronic Appendicitis Cholecystitis Pyelonephritis Recurrent UTI Diabetes Mellitus Metabolic disorders like Hyperthyroidism Hyperparathyroidism
Pelvic Inflammatory Disease Chronic Renal Failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of taial drug NERUNJI VER KUDINEER in KALLADAIPPU |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Sidhha diagnostic parameters safety of trial drug Pharmacological and Biochemical analysis of trial drug |
30 days |
|
|
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)
|
03/04/2018 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is A Prospective Open Labelled Non Randomized clinical study to evaluate the therapeutic efficacy of NERUNJI VER KUDINEER 100ml BD for30 days in 40 patients during the trial period of 15 months that will be conducted in Govt Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu The primary outcome will be the therapeutic efficacy of trial drug NERUNJI VER KUDINEER in KALLADAIPPU The secondry outcome will be the evaluation of Siddha diagnostic parameters safety of trial drug Pharmacological and Biochemical analysis of trial drug |