| CTRI Number |
CTRI/2021/01/030216 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
30/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of the effect on oral administration of Siddha classical drug VILVA ENNAI for the treatment of BRONCHIOLITIS. |
|
Scientific Title of Study
|
Clinical evaluation of the effect on oral administration of VILVA ENNAI for the treatment of VALI KANAM. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Ragavi Sayi Saranya |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8072252679 |
| Fax |
|
| Email |
drsairagavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Shyamala MDs |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Shyamala MDs |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli - 627002 |
|
|
Primary Sponsor
|
| Name |
Dr K Ragavi Sayi Saranya |
| Address |
II year PG Scholar, Department of Kuzhanthai Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli - 627002. |
| 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 Ragavi Sayi Saranya |
Government siddha medical college and hospital, Palayamkottai |
Department of
kuzhanthai
Maruthuvam,
Government Siddha
Medical College and
Hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU |
8072252679
drsairagavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
VILVA ENNAI |
Should be administered orally once a day at morning before the food for a period of 10 days
Dose : 4 ml |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
subjects with any of the following symptoms will be included in the study
1. Fever associated with Respiratory symptoms, Urinary tract symptoms and Gastrointestinal symptoms
2. Loss of appetite
3. Cough
4. Vomitting
5. Wheezing
6. Decreased urine output
7. Thirsty
8. Dryness of mouth
9. Constipation |
|
| ExclusionCriteria |
| Details |
1. Children below 3 years and above 12 years
2. Fever due to malignancy, trauma, psychological factors
3. High grade fever
4. Cough with hemoptysis
5. Fever associated with other complications such as HIV, meningitis, Tuberculosis
6. Cardiac diseases
7. Chronic Renal diseases
8. Severe Dehydration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreases the body temperature, cough, vomitting, constipation and other clinical symptoms. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/01/2021 |
| Date of Study Completion (India) |
02/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Evaluation of analytical specifications of Siddha herbal formulation VILVA ENNAI for VALI KANAM & Standardization of Siddha drug formulation MANDOORA ADAI KIYAZHAM for the management of VADHA SOOBAI |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is a single arm clinical trial to evaluate the therapeutic efficacy of VILVA ENNAI for the treatment of VALI KANAM. The trial drug will be administered orally at the dose of 4 ml before the food once a day at morning for a period of 10 days in 56 patients. The trial period of 24 months will be carrying out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. |