| CTRI Number |
CTRI/2026/03/105176 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Evaluate the effect of siddha medicine Eelai Erumal Chooranam in Patients with Swasakasam ( Bronchial Asthma ) |
|
Scientific Title of Study
|
SINGLE CENTRIC PHASE II OPEN CLINICAL TRIAL IN SWASAKASAM (BRONCHIAL ASTHMA) WITH SIDDHA MEDICINE “EELAI ERUMAL 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 P HEMA |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI |
| Address |
Room No S1, Department of PG Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai-600106
Chennai
TAMIL NADU
600106
India |
| Phone |
8056266460 |
| Fax |
|
| Email |
hemapagan54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U CHITRA |
| Designation |
LECTURER |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, ARUMBAKKAM, CHENNAI |
| Address |
Room No S1, Department of PG Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai-600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr U CHITRA |
| Designation |
LECTURER |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, ARUMBAKKAM, CHENNAI |
| Address |
Room No S1, Department of PG Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai-600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr P Hema |
| Address |
Room No S1, Department of PG Pothu Maruthuvam, 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 |
| Dr P HEMA |
GOVERNMENT SIDDHA MEDICAL COLLEGE, ARUMBAKKAM, CHENNAI |
Room No S1, Department of PG Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai-600106
Chennai
TAMIL NADU |
08056266460
hemapagan54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI - 600106 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eelai Erumal chooranam |
1 Part of each Ingredients - Purified Justicia adathoda Ocimum tenuiflorum
Solanum procumbens
Solanum xanthocarpum
Wedelia chinensis
Mukia maderaspatana
Ocimum album
Acalypha indica
Saccharum officinarum will be collected, thoroughly washed, shade-dried and then sun-dried to constant weight. The dried material will be pulverized separately, and sieved . Then a specified quantity of White sugar will be added and mixed uniformly and preserved in air container. 1g of the medicine will be given with honey for 48 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Moderate cases of Bronchial Asthma as Evaluated by Spirometry Assessment
FEV1 FVC PEF 60 TO 80 Percentage
Ratio of FEV1 and FVC Less than 0.75 - 0.80 |
|
| ExclusionCriteria |
| Details |
AGE Greater than 50 YEARS
Other systemic illness
Vulnerable population
Known case of Bronchiectasis and Pulmonary TB
Subject who are unwilling or unable to comply with the trial protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome is mainly assessed by
Reduction in clinical symptoms after treatment
The Outcome is to improve the baseline Spirometry parameter scores. |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome is mainly assessed by
Reduction in clinical symptoms after treatment
The Outcome is to improve the baseline Spirometry parameter scores. |
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)
|
18/05/2026 |
| 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 - All of the individual participant data collected during the trial, after de-identification.
- 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 who provide a methodologically sound proposal.
- 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 [hemapagan54@gmail.com].
- For how long will this data be available start date provided 23-03-2026 and end date provided 26-03-2030?
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 2 open clinical trial in swasakasam ( Bronchial Asthma ) With Siddha Medicine Eelai Erumal Chooranam The Dosage of Eelai erumal chooranam is 1 gram with honey ( Twicw a Day ) for 48 Days The sample Size for the study is 44 Outcome is mainly assessed by Reduction in clinical symptoms after treatment The Outcome is to improve the baseline Spirometry parameter scores. |