| CTRI Number |
CTRI/2018/07/014950 [Registered on: 18/07/2018] Trial Registered Prospectively |
| Last Modified On: |
01/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
An open clinical study to evaluate the efficacy of trial drug suganthamalli chooranam for lasunathabitham |
|
Scientific Title of Study
|
An open clinical study to evaluate the clinical efficacy of siddha sasthric formulation suganthamalli chooranam for the treatment of lasunathabitham |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K RUBA |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College Palayamkottai |
| Address |
Op no 7 Department of Kuzhanthai Maruthuvam
Tirunelveli
Op no 7 Department of Kuzhanthai Maruthuvam
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9047799776 |
| Fax |
0 |
| Email |
dr.rubabsms93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Shyamala |
| Designation |
Lecturer |
| Affiliation |
Govt Siddha Medical College Palayamkottai |
| Address |
Op no 7 Department of Kuzhanthai Maruthuvam
Government siddha medical college and hospital
Op no 7 Department of Kuzhanthai Maruthuvam
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
Shyamsujisathya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K RUBA |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College Palayamkottai |
| Address |
Op no 7 Department of kuzhanthai Maruthuvam
Op no 7 Department of Kuzhanthai Maruthuvam
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9047799776 |
| Fax |
|
| Email |
dr.rubabsms93@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD Government Siddha Medical College and Hospital Palayamkottai |
| Library Government Siddha Medical College and Hospital Palayamkottai |
|
|
Primary Sponsor
|
| Name |
K RUBA |
| Address |
Govt Siddha Medical College and Hospital Palayamkottai |
| Type of Sponsor |
Other [PG Scholar Stifund] |
|
|
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 |
| K RUBA |
Govt Siddha Medical College and hospital palayamkottai |
Op no 7 Dept of Kuzhanthai Maruthuvam Palayamkottai
Tirunelveli
TAMIL NADU |
9047799776
dr.rubabsms93@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
Lasunathabitham, (1) ICD-10 Condition: J030||Streptococcal tonsillitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Suganthamalli chooranam |
2g according to the body weight tds with milk orally for 14 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patient with appropriate symptoms of throat pain dysphagia hoarseness of voice enlarged tonsils referred pain in the ear malaise mild fever with tonsillitis |
|
| ExclusionCriteria |
| Details |
congenital anomalies of pharynx physiological hyperplasia of lymphoid follicles malignancy tonsillitis which have indication for surgery tonsilolith quincy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The therapeutic efficacy of trial drug SUGANTHAMALLI CHOORANAM on LASUNATHABITHAM |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of siddha diagnostic parameters |
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)
|
23/07/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/07/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
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
|
The study is prospective open labeled non randomized phase II clinical trial to evaluate the therapeutic efficacy of trial drug suganthamalli chooranam 2 g according to the body weight tds with milk for 14 days in 40 patients during the trial period of 13 months that will be conducted in government siddha medical college and hospital Palayamkottai Tamilnadu The primary outcome will be the therapeutic efficacy of trial drug suganthamalli chooranam on Lasunathabitham The secondary outcome will be the evaluation of siddha diagnostic parameters |