| CTRI Number |
CTRI/2021/11/037781 [Registered on: 03/11/2021] Trial Registered Prospectively |
| Last Modified On: |
01/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Siddha
Other (Specify) [Interventional study] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
samuthara chooranam for Irritable bowel syndrome(maha vatham) |
|
Scientific Title of Study
|
Phase II non-randomised open clinical evaluation of siddha medicine samuthara chooranam for the management of maha vatham(Irritable bowel syndrome) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Suganya |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Second year PG scholar Department of Pothu maruthuvam Government Siddha Medical College,Arumbakkam,Chennai-106
Second year PG scholar Department of Pothu maruthuvam Government Siddha Medical College,Arumbakkam,Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
6383982810 |
| Fax |
|
| Email |
suganyamyindia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sasirekha |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Department of Pothu maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai-106
Department of Pothu maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444832728 |
| Fax |
|
| Email |
sasirekha.siddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Suganya |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Second year PG scholar Department of Pothu maruthuvam Government Siddha Medical College,Arumbakkam,Chennai-106
Second year PG scholar Department of Pothu maruthuvam Government Siddha Medical College,Arumbakkam,Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
6383982810 |
| Fax |
|
| Email |
suganyamyindia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College, Arumbakkam Chennai-106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College,Arumbakkam,Chennai-600106 |
| 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 |
| P Suganya |
Arignar Anna Hospital of Indian Medicine and Homoeopathy |
Room no S-1, Department of Pothu maruthuvam Government Siddha Medical College,Arumbakkam,Chennai-600106
Chennai
TAMIL NADU |
6383982810
suganyamyindia@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: K580||Irritable bowel syndrome with diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
SAMUTHARA CHOORANAM |
6 grams of samuthara chooranam is administrated twice in a day with ghee for 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both gender ,age limit below 60 years
Altered bowel habits
Abdominal pain or discomfort often exacerbated by eating
Abdominal distension and increased belching
Dyspepsia ,heartburn, nausea |
|
| ExclusionCriteria |
| Details |
Ulcerative colitis
Colon cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by reduction in the clinical symptoms. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing before and after treatment. |
48 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)
|
10/11/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
This is a single Non randomised open clinical trial to study the safety and efficacy of siddha trial drug samuthara chooranam . The trial drug is given 6grams twice a day for 48 days. Clinical trial is conducted after conducting pre clinical toxicity study. The trial drug samuthara chooranam is mentioned in kosaye anuboga vaithiya brahma ragasiyam. During the trial all the study related data will be recorded and documented. After the completion of the trial all the data will be analysed statistically. |