| CTRI Number |
CTRI/2023/05/052505 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| 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 Sivathai chooranam in the management of Vatha gunmam (Peptic ulcer disease) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMISED,SINGLE CENTRIC PHASE II CLINICAL EVALUATION OF SIVATHAI CHOORANAM IN THE MANAGEMENT OF VATHA GUNMAM (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 |
Dr N Vasanthi |
| Designation |
PG Scolar |
| Affiliation |
Government Siddha Medical College And Hospital |
| Address |
Department of Pothu Maruthuvam,Government Siddha Medical
College and Hospital, Palayamkottai, Tirunelveli-627002,Tamilnadu.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9600328906 |
| Fax |
|
| Email |
drvasanthinatarajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Koamalavalli MDsPhD |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College And Hospital |
| Address |
PG Department of Pothu Maruthuvam,OP no 10,Government Siddha
Medical College and Hospital, Palayamkottai, Tirunelveli-627002,
Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
Komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr A Manoharan MDsPhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College And Hospital |
| Address |
PG Department of Pothu Maruthuvam,OP no 10,Government Siddha
Medical College and Hospital, Palayamkottai, Tirunelveli-627002,
Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of Government Siddha Medical College And Hospital, Palayamkottai, Tirunelveli, Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College And Hospital |
| Address |
Government Siddha Medical College And Hospital,Palayamkottai, Tirunelveli, Tamilnadu |
| 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 |
| DrN Vasanthi |
Government Siddha Medical College And Hospital |
Department of Pothu Maruthuvam OP no 10 Government Siddha Medical College And Hospital Palayamkottai
Tirunelveli
TAMIL NADU |
9600328906
drvasanthinatarajan@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K273||Acute peptic ulcer, site unspecified, without hemorrhage or perforation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Sivathai chooranam |
Dosage:500mg-1gm
Route:Orally
Frequency:twice a day
Adjuvant:Hot water
Duration: 45 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms with abdominal pain,fatigue and weakness,bodypain,headache,dizziness,polydipsia,xerostomia,constipation,vomiting and indigestion.
2.Patients who are willing to take upper gastrointestinal endoscopy
3. Patients who are willing to give blood specimen for lab investigation when required.
4.Patient willing to sign the informed consent indicating that they understand the purpose and procedures required for the study and are willing to participating the study |
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Lactating mother
3. Recent malignancy or radiation therapy
4.Gastro esophageal reflux disease
5.Pancreatitis
6.Inflammotary Bowel Disease
7.Acute hepatitis
8.Patients considered unreliable by the investigator (e.g: drug addiction,
Alcohol abuse)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome is the reduction in clinical symptoms of abdominal pain, fatigue and weakness, body pain,headache,dizziness ,polydipsia,xerostomia, constipation, vomiting and indigestion |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be the evaluation of siddha diagnostic parameters assessment of safety profile of trial drug assesment of pharmacological and biochemical parameters of the trial drug |
45 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)
|
21/05/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective open labelled phase II Non randomized clinical study to evaluate the therapeutic efficacy of Sivathai Chooranam in the management of Vatha gunmam (Peptic ulce disease).The trial drug will be administered at the dose of 500 mg to 1 gram/ twice a day (orally with hot water) 45 days in 40 patients.The trial period of 12 months will be carried out in Government Siddha Medical College And Hospital Palayamkottai Tirunelveli Tamilnadu.The primary outcome will be the evaluation of therapeutic efficacy of the trial drug SIVATHAI CHOORANAM.The secondary outcome will be the evaluation of siddha diagnostic parameters, assessment of safety profile of trial drug, assesment of pharmacological and biochemical parameters of the trial drug.In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilance department of SCRI.Further management of patients of will be given in OPD facilities. |