| CTRI Number |
CTRI/2020/12/029979 [Registered on: 22/12/2020] Trial Registered Prospectively |
| Last Modified On: |
27/05/2022 |
| 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 of siddha classical drug ELATHI CHOORANAM(Internal) and KAIYANTHAGARAI TAILAM(external) in the Management of RHINITIS. |
|
Scientific Title of Study
|
Clinical evaluation of the effect on oral administration of ELATHI CHOORANAM along with external administration of KAIYANTHAGARAI TAILAM in the management of VADHAPEENISAM. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Vidhya Rajeswari |
| 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 |
7904139247 |
| Fax |
|
| Email |
vidyasekar911@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,Thirunelveli.
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,Thirunelveli.
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,Thirunelveli-627002 |
|
|
Primary Sponsor
|
| Name |
Dr S Vidhya Rajeswari |
| Address |
IIyear PG Scholar
Department of Kuzhanthai Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Thirunelveli 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 S Vidhya Rajeswari |
Government Siddha Medical College and Hospital,Palayamkottai |
Department of Kuzhanthai Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Thirunelveli
627002
Tirunelveli
TAMIL NADU |
7904139247
vidyasekar911@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: J310||Chronic rhinitis, (2) ICD-10 Condition: J302||Other seasonal allergic rhinitis, (3) ICD-10 Condition: J301||Allergic rhinitis due to pollen, (4) ICD-10 Condition: J305||Allergic rhinitis due to food, (5) ICD-10 Condition: J308||Other allergic rhinitis, (6) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ELATHI CHOORANAM(oral administration)
KAIYANTHAGARAI TAILAM(external administration)
|
Should be administrated orally twice a day after food along with honey when a period of 21 days.Dosage:500mg-1gram
External administration of oil bath 5 days once x 5 times
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
7.00 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.Pain and swelling of the maxillary region
2.Frequent Sneezing with seasonal allergy
3.Frequent focusing for allergy
4.Prolonged running nose(Rhinitis) |
|
| ExclusionCriteria |
| Details |
1.Children below 7 years and above 12 years
2.Severe and recurrent epistaxis due to rhinitis
3.Rhinisporidiasis
4.TB rhinitis
5.Severe form of DNS(Deviated Nasal Septum) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreases the frequency of sneezing, prolonged running nose, nasal congestion and other clinical symptpoms. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/12/2020 |
| Date of Study Completion (India) |
30/04/2022 |
| 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)
|
1. Standardization of sidha drug formulation Elathi Chooranam for the management of Vadha Peenisam.
2.A literature review of the Poly Herbal formulation (Uththamani Nei) which in commonly used in Seriya Maantham in siddha medical system. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is a single arm clinical trial to determine the safety and efficacy of ELATHI CHOORANAM(oral administration) along with KAIYANTHAGARAI TAILAM (external administration) in patients with VADHAPEENISAM. The outcome will measured by day 1,week 1 week 2, week 3 intervals.During this period if any adverse effect and serious adverse effect will be noticed and referred to pharmacovigilance department in Government siddha medical college and hospital, Palayamkottai and for the management will also be given in department of Kuzhanthai maruthuvam OPD and IPD. After the completion of trial all the study related data will be analyzed statistically. |