| CTRI Number |
CTRI/2020/09/027621 [Registered on: 07/09/2020] Trial Registered Prospectively |
| Last Modified On: |
27/08/2020 |
| 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 to study the effect of Siddha Medicine Hingu Chooranam for Vaayu Gunmam (Gastritis) |
|
Scientific Title of Study
|
Phase II Non-Randomized Open Clinical Evaluation of Siddha Medicine Hingu Chooranam for Vaayu Gunmam (Gastritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shakeena Parveen A |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate
Department of General Medicine Government Siddha
Medical College
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9094598666 |
| Fax |
|
| Email |
shakeen12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ujjeevanam G |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Professor
Department of General Medicine Government Siddha
Medical College
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9884175653 |
| Fax |
|
| Email |
ujjeevanam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shakeena Parveen A |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate
Department of General Medicine Government Siddha
Medical College
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9094598666 |
| Fax |
|
| Email |
shakeen12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College Arumbakkam Chennai 600106
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 Shakeena Parveen A |
Arignar Anna Government Hospital of Indian Medicine |
Room no S1 Ground floor
Siddha Department
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU |
9094598666
shakeen12@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: K297||Gastritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hingu Chooranam |
1 gram of Hingu Chooranam is administered with luke warm water twice a day for 30 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Indigestion
Nausea
Vomiting
Abdominal bloating
Abdominal pain
|
|
| ExclusionCriteria |
| Details |
Gastric perforation
Appendicitis
Pancreatitis
Cholelithiasis
CA of stomach
Pregnancy&lactation
Renal colic
Pyloric stenosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by reduction in the clinical symptoms of abdominal pain, abdominal bloating, indigestion, nausea and vomiting. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is assessed by comparing the the clinical symptoms before and after treatment. |
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)
|
01/10/2020 |
| 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 is a Phase II Non Randomized open clinical evaluation of Siddha Medicine Hingu Chooranam for Vaayu Gunmam (Gastritis). The trial drug is given 1 gram twice a day with luke warm water for 30 days. The trial drug is mentioned in Sarabendirar Vaithiya Muraigal - Gunma Roga Sikichai. During the trial all the related data will be collected,documented and analysed.
|