| CTRI Number |
CTRI/2018/12/016563 [Registered on: 07/12/2018] Trial Registered Prospectively |
| Last Modified On: |
05/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
THE CLINICAL TRIAL TO STUDY THE EFFECT OF THE DRUG SHANMUGA CHOORANAM IN PATIENTS HAVING GASTRIC REGURGITATION |
|
Scientific Title of Study
|
EVALUATION OF SHANMUGA CHOORANAM FOR URAGARI VATHAM(GASTRO OESOPHAGEAL REFLUX DISEASE)-AN OPEN CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR YAMUNA R |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEAGE ARUMBAKKAM CHENNAI |
| Address |
DEPARTMENT OF GENERAL MEDICINE
GOVERNMENT SIDDHA MEDICAL COLLEGE
6 ANNA ARCH ROAD
NSK NAGAR
ARUMBAKKAM
CHENNAI
TAMIL NADU
INDIA
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9791421240 |
| Fax |
|
| Email |
dryamuna75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHITRA S M |
| Designation |
LECTURER GRADE II |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI |
| Address |
DEPARTMENT OF GENERAL MEDICINE
GOVERNMENT SIDDHA MEDICAL COLLEGE
6 ANNA ARCH ROAD
NSK NAGAR
ARUMBAKKAM
CHENNAI
TAMIL NADU
INDIA
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444177230 |
| Fax |
|
| Email |
chittu758@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR YAMUNA R |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI |
| Address |
DEPARTMENT OF GENERAL MEDICINE
GOVERNMENT SIDDHA MEDICAL COLLEGE
6 ANNA ARCH ROAD
NSK NAGAR
ARUMBAKKAM
CHENNAI
TAMIL NADU
INDIA
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9791421240 |
| Fax |
|
| Email |
dryamuna75@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT SIDDHA MEDICAL COLLEAGE ARUMBAKKAM CHENNAI |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
| Address |
NO 6 ANNA ARCH ROAD ARUMBAKKAM CHENNAI 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 |
| DR YAMUNA R |
ARIGNAR ANNA GOVERNMENT HOSPITAL FOR INDIAN MEDICINE |
ROOM NO 2
SIDDHA DEPARTMENT
6 ANNA ARCH ROAD
NSK NAGAR
ARUMBAKKAM
CHENNAI
TAMIL NADU
INDIA
600106
Chennai
TAMIL NADU |
9791421240
dryamuna75@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 |
(1) ICD-10 Condition: K92||Other diseases of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SHANMUGA CHOORANAM |
SHANMUGA CHOORANAM IS ADMINISTRATTED ORALLY AT THE DOSE OF 5gOD ALONG WITH GHEE FOR 48 DAYS |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
LOSS OF APPETITE
DYSPHAGIA
HEART BURN DUE TO INDIGESTION
REGURGITATION |
|
| ExclusionCriteria |
| Details |
HIATUS HERNIA
CHOLELITHIASIS
PYLORIC STENOSIS
ESOPHAGEAL CARCINOMA
HELICOBACTER PYLORI
ESOPHAGEAL CARCINOMA
PREGNANT WOMEN
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OUTCOME IS MAINLY ASSESSED BY REDUCTION IN CLINICAL SYMPTOMS AND BY COMPARING THE INVESTIGATIONAL PARAMETERS BEFORE AND AFTER TREATMENT |
OUTCOME IS MAINLY ASSESSED BY REDUCTION IN CLINICAL SYMPTOMS AND BY COMPARING THE INVESTIGATIONAL PARAMETERS BEFORE AND AFTER TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
10/12/2018 |
| 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="0"
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
|
THIS IS A SINGLE NON-RANDOMIZED OPEN CLINICAL TRIAL TO STUDY THE SAFTEY AND EFFICACY OF SIDDHA TRIAL DRUG SHANMUGA CHOORANAM.THE TRIAL DRUG GIVEN 5g ONCE A DAY ALONG WITH GHEE FOR 48 DAYS.CLINICAL TRIAL IS CONDUCTED AFTER CONDUCTING PRECLINICAL TOXICITY STUDY.THE TRIAL DRUG SHANMUGA CHOORANAM IS MENTIONED IN ANUBOGA VAIDHIYA BRAHMA RAGASIYAM .DURING THE TRIAL ALL THE STUDY RELATED DATA WILL BE RECORDED AND DOCUMENTED.AFTER THE COMPLETION OF TRIAL ALL THE DATA WILL BE ANALYSED STASTISCALLY |