| CTRI Number |
CTRI/2017/08/009270 [Registered on: 04/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
04/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of trial drug UPPU CHENDURAM II on Gunmam(Peptic Ulcer) |
|
Scientific Title of Study
|
A prospective open Labeled randomized clinical trial on "Eri Gunmam"(Peptic Ulcer Disease )with evaluation of trial drug "Uppu Chenduram-II" " |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
T Bhuvaneshwari |
| Designation |
PG student |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
II year OP number 10 PG Dept of Pothu Maruthuvam Government Siddha Medical college and hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8148585049 |
| Fax |
|
| Email |
bhuvana_tag@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G Subash chandran MD Siddha PhD |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
7th Perumal North Mada street Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G Subash chandran MD Siddha PhD |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
7th Perumal North Mada street Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD of Government Siddha Medical college and hospital |
| Library Government Siddha Medical college and hospital |
|
|
Primary Sponsor
|
| Name |
S Neelavathi |
| 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 |
| T Bhuvaneshwari |
Government Siddha Medical college and hospital |
OP number 10 PG Dept of Pothu Maruthuvam Government Siddha Medical college and hospital Palayamkottai
Tirunelveli
TAMIL NADU |
0462-2572738
0462-2582010
bhuvana_tag@yahoo.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
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Uppu Chenduram II |
130 mg orally bid with warm water 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 upper abdominal pain nausea waterbrash headache flatulence excessive sweating loss of body weight lack of food intake Patient who are willing to sign consent form and undergo laboratory investigations |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women Haemetemesis Malena Pancreatitis Inflammatory bowel disease Hyertensive heart disease Chronic kidney disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The therapeutic efficacy of trial drug Uppu Chenduram II on Eri Gunmam |
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)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/07/2017 |
| Date of Study Completion (India) |
30/07/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The results of this clinical trial have been submitted as a dissertation to The Tamil Nadu Dr. M.G.R. Medical University in 2018. The dissertation is not yet published in any peer-reviewed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is prospective open Labeled randomized phase II clinical trial to evaluate the therapeutic efficacy of UPPU CHENDURAM II 130 mg bid with warm water for 30days in 40 patients during the trial period of 12 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 UPPU CHENDURAM II on ERIGUNMAM The secondary outcome will be the evaluation of Siddha diagnostic parameters |