| CTRI Number |
CTRI/2021/07/034780 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
11/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Vali kana kudineer for Vali kanam (Acute pharyngitis) in children |
|
Scientific Title of Study
|
PHASE II NON RANDOMIZED CLINICAL STUDY ON VALI KANAM (ACUTR PHARYNGITIS) WITH THE EVALUATION OF SIDDHA TRIAL DRUG VALI KANA KUDINEER IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Sivapriya |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai-106. |
| Address |
Post Graduate Room no 25 Department Of Kuzhanthai Maruthuvam Government Siddha Medical College Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8939072312 |
| Fax |
|
| Email |
rsivapriya11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rani v |
| Designation |
HOD and Lecturer |
| Affiliation |
Governnment siddha medical college |
| Address |
Post Graduate Head Of The Department Department Of Kuzhanthai Maruthuvam Government Siddha Medical College Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
6369113461 |
| Fax |
|
| Email |
drvranimd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sivapriya |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha medical college |
| Address |
Post Graduate Room no 25 Department Of Kuzhanthai Maruthuvam Government Siddha Medical College Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8939072312 |
| Fax |
|
| Email |
rsivapriya11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment Siddha Medical College Chennai |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
6,Anna Arch Road NSK Nagar Arumbakkam Chennai-106 |
| 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 R Sivapriya |
Government siddha medical college |
Room no 25 Department of Kuzhanthai Maruthuvam NSK Nagar Arumbakkam Chennai 106
Chennai
TAMIL NADU |
8939072312
rsivapriya11@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: J029||Acute pharyngitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vali Kana Kudineer |
15-30 ml of decoction bd for 14 days |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Fever Sore throat Hoarseness of Voice Cough Pharyngeal Tonsillar Erythema Cervical Adenopathy Rhinitis |
|
| ExclusionCriteria |
| Details |
Peritonsillar Abscess Rheumatic Fever Diptheria Infective Mononucleosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Centor Score Reduction in Clinical Symptoms |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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)
|
20/07/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
This is a Single Non Randomized Open Clinical Trial to Study the Safety and efficacy of Siddha Trial Drug Vali Kana Kudineer is to be given about 15-30 ml twice a day for 14 days.Clinical Trial Conducted after conducting Pre Clinical Toxicity Study. The Trial Drug Vali Kana Kudineer has mentioned in Pillai Pini Maruthuvam - 2. During the trial study related data will be recorded and documented. After the completion of trial all data will be statistically analysed. |