| CTRI Number |
CTRI/2018/04/012924 [Registered on: 02/04/2018] Trial Registered Prospectively |
| Last Modified On: |
27/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of drug VELLARUGU CHOORANAM on Gunman (peptic ulcer) |
|
Scientific Title of Study
|
A prospective open labeled non randomized phase II clinical trial to assess therapeutic efficacy of the Siddha formulation Vellarugu chooranam for the treatment of Erigunmam (Peptic Ulcer Disease) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M MUTHUMARI |
| Designation |
PG Student |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Op number 10
PG Dept of Pothu Maruthuvam
Government siddha medical college and hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8220606063 |
| Fax |
|
| Email |
dr.muthumari23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T KOMALAVALLI MD siddha PhD |
| Designation |
Associate Professor |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of Pothu maruthuvam Government siddha medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T KOMALAVALLI MD siddha PhD |
| Designation |
Associate Professor |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of Pothu maruthuvam Government siddha medical college and hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD
Government Siddha Medical College and Hospital
Palayamkottai |
| Library
Government Siddha​ Medical College and Hospital
Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Dr S Neelavathi MD siddha PhD |
| Address |
Principal government siddha medical college and hospital palayamkottai |
| 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 |
| M MUTHUMARI |
Government Siddha Medical College and Hospital |
Op number 10
PG Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
8220606063
dr.muthumari23@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 |
ERIGUNMAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Vellarugu chooranam |
30mg/Kg/BW/daily bid with warm water orally for 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with appropriate symptoms of burning pain in upper abdomen nausea waterbrash headache flatulence dizziness excessive sweating loss of body weight lack of food intake neuritic pain cough patient who are willing to sign consent form and undergo laboratory investigations |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women haemetemesis Malena pancreatitis inflammatory bowel disease recent malignancy or radiation therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The therapeutic efficacy of trial drug VELLARUGU CHOORANAM on ERIGUNMAM |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of siddha diagnostic parameters |
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)
|
05/04/2018 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is prospective open Labeled non randomized phase II clinical trial to evaluate the therapeutic efficacy of trial drug Vellarugu Chooranam 30mg/kg/BW/two times a day with warm water for 30 days in 40 patients during the trial period of 15 months that will be conducted in Government Siddha Medical college and hospital Palayamkottai Tamilnadu The primary outcome will be the therapeutic efficacy of trial drug Vellarugu Chooranam on ERIGUNMAM The secondary outcome will be the evaluation of Siddha diagnostic parameters |