| CTRI Number |
CTRI/2026/04/107405 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study of siddha medicine Sundai Vatral Chooranam for Maga vatham (Irritable bowel syndrome) |
|
Scientific Title of Study
|
Single Centric Phase II Open clinical trial in Maga Vatham(Irritable bowel syndrome) with siddha medicine Sundai Vatral Chooranam. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Jamuna |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI |
| Address |
Room no S1, Department of PG pothu maruthuvam Govt siddha medical College, Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
8940190547 |
| Fax |
|
| Email |
drjamuna05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Menaka |
| Designation |
LECTURER |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI |
| Address |
Room no S1, Department of PG pothu maruthuvam Govt siddha medical College, Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9444669661 |
| Fax |
|
| Email |
rangasamymenaka75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Menaka |
| Designation |
LECTURER |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI |
| Address |
Room no S1, Department of PG pothu maruthuvam Govt siddha medical College, Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9444669661 |
| Fax |
|
| Email |
rangasamymenaka75@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr K Jamuna |
| Address |
Room no S1, Department of PG pothu maruthuvam Govt siddha medical College, Arumbakkam, Chennai - 600106, India |
| Type of Sponsor |
Other [Self] |
|
|
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 K Jamuna |
GOVERNMENT SIDDHA MEDICAL COLLEGE & HOSPITAL |
Room No S1, DEPARTMENT OF PG POTHU MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE & HOSPITAL, ARUMBAKKAM, CHENNAI - 600106
Chennai
TAMIL NADU |
8940190547
drjamuna05@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 |
| Intervention |
Sundai Vatral Chooranam |
Sundai vatral , Nelli vatral, Madhulampazhathol , Vendhayam Karivepilai , Mamparuppu, Omam , All the above purified ingredients will be taken in equal quantity then powdered and seived using cloth. The trail drug is stored in clean dry and air tight container and it is dispensed to the patients in labelled container. 750 mg ( twicw a day ) with Erumai Tayir for 48 Days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Based upon the Rome IV criteria
Recurrent abdominal pain or discomfort at least 1 day per week on average in the
last 3 months (onset at least 6 months before diagnosis),associated with two or more of the
followings
Related to defecation,
Onset associated with a change in frequency of stool,
Onset associated with a change in form (appearance) of stool. |
|
| ExclusionCriteria |
| Details |
Postinfectious IBS (Campylobacter,Salmonella,and Shigella)
Known Complaints of Inflammatory Bowel Disease(IBD)
,
Ulcerative colitis,
Crohn’s disease,
Autoimmune inflammatory disease
Amoebic dysentery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome is assessed by IBS-Symptom Severity Scale(IBS-SSS)
Severe to Moderate,
Moderate to mild. |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome is assessed by IBS-Symptom Severity Scale(IBS-SSS)
Severe to Moderate,
Moderate to mild. |
48 Days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
04/05/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drjamuna05@gmail.com].
- For how long will this data be available start date provided 04-05-2026 and end date provided 03-05-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is Single Centric Phase II Open clinical trial in Maga Vatham (Irritable bowel syndrome) with siddha medicine Sundai Vatral Chooranam. The Dosage of Sundai Vatral Chooranam 750 mg ( twice a day ) with erumai thayir for 48 days . The Sample Size for the study is 44.
Outcome is assessed by IBS-Symptom Severity Scale(IBS-SSS) Severe to Moderate, Moderate to mild. |