CTRI Number |
CTRI/2019/11/022196 [Registered on: 27/11/2019] Trial Registered Prospectively |
Last Modified On: |
27/11/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Siddha |
Study Design |
Single Arm Study |
Public Title of Study
|
Clinical trial to evaluate the efficacy of kana kudineer in children for Vali Kanam(Acute pharyngitis) |
Scientific Title of Study
|
Phase II an open single group non randomized study on valikanam (Acute pharyngitis) to evaluate the official Siddha formulation kana kudineer-In children of both sex aging between 3-12 years attending opd at Anna hospital |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Kalishwari B |
Designation |
PG scholar |
Affiliation |
Government Sidha Medical College |
Address |
Post Graduate Department of Kuzhanthai Maruthuvam Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam
Chennai TAMIL NADU 600106 India |
Phone |
7708824333 |
Fax |
|
Email |
drabibala8894@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rani V |
Designation |
HOD and professor |
Affiliation |
Government Siddha Medical College |
Address |
Post Graduate Department of Kuzhanthai Maruthuvam Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam
Chennai TAMIL NADU 600106 India |
Phone |
9442286863 |
Fax |
|
Email |
ranimoorthybsms19@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kalishwari B |
Designation |
PG scholar |
Affiliation |
Government Siddha Medical College |
Address |
Post Graduate Department of Kuzhanthai Maruthuvam Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam
Chennai TAMIL NADU 600106 India |
Phone |
7708824333 |
Fax |
|
Email |
drabibala8894@gmail.com |
|
Source of Monetary or Material Support
|
Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu |
|
Primary Sponsor
|
Name |
Government Siddha Medical College |
Address |
Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu |
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 Kalishwari B |
Aringar Anna Government Hospital Of Indian Medicine |
Room no 25 Siddha Department 6 Anna arch road NSK Nagar Arumbakkam Chennai TAMIL NADU |
7708824333
drabibala8894@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: J02||Acute pharyngitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Kana kudineer |
15-30 ml
Twice a day
14 days |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
3-12 years
Fever
Sore throat / throat pain
Hoarseness of voice
Cough
Pharyngeal Tendulkar erythema
Cervical adenopathy
Rhinitis |
|
ExclusionCriteria |
Details |
Peritonsillar abscess
H/O Rheumatic fever
Diptheria
Inductive mononucleosis |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in center score
Reduction in clinical symptoms like fever, throat pain, sore throat and cough |
14 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
It is assessed by comparing the safety parameters before and after treatment |
14 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)
|
02/12/2019 |
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)?
|
Brief Summary
|
This is a single non randomized open clinical trial to study the safety and efficacy of Siddhartha trial drug kana kudineer. The trial drug is given 15-30ml twice a day for 14days. Clinical trial is conducted after conducting pretty clinical toxicity study. The trial drug kana kudineer is mentioned in pillai pini maruthuvam part II. During the trial all the study relateddata will be recorded and documented. After the completion of trial all the data will be analysed statistically. |