| CTRI Number |
CTRI/2019/05/019469 [Registered on: 31/05/2019] Trial Registered Prospectively |
| Last Modified On: |
29/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
treatment for throat problem (tonsillitis) |
|
Scientific Title of Study
|
Determination of efficacy of Siddha Polyherbal formulation Saya chooranam in Tonsillitis - Lasuna thabitham |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR A MARIYA LOURTHU GRACY |
| Designation |
PG SCHOLAR |
| Affiliation |
AYODIDASS PANDITHAR HOSPITAL NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
DEPARTMENT OF NOINAADAL
OP NO 5
TAMBARAM SANATORIUM CHENNAI
NATIONAL INSTITUTE OF SIDDHA
DEPARTMENT OF NOINAADAL
OP NO 5
TAMBARAM SANATORIUM CHENNAI 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8508973365 |
| Fax |
|
| Email |
drgracy10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M RAMAMURTHY |
| Designation |
LECTURER |
| Affiliation |
AYODIDASS PANDITHAR HOSPITAL NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9443178112 |
| Fax |
|
| Email |
ramsnis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR A MARIYA LOURTHU GRACY |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 47 |
| Address |
NATIONAL INSTITUTE OF SIDDHA
DEPARTMENT OF NOINAADAL
OP NO 5
TAMBARAM SANATORIUM CHENNAI
NATIONAL INSTITUTE OF SIDDHA
DEPARTMENT OF NOINAADAL
OP NO 5
TAMBARAM SANATORIUM CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8508973365 |
| Fax |
|
| Email |
drgracy10@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYODIDAASAR PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM CHENNAI 47 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
AYODIDASS PANDITHAR HOSPITAL NATIONAL INSTITUTE OF SIDDHA WEST TAMBARAM CHENAAI 600047 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 A MARIYA LOURTHU GRACY |
AYODIDASS PANDITHAR HOSPITAL NATIONAL INSTITUTE OF SIDDHA |
AYODIDASS PANDITHAR HOSPITAL NATIONAL INSTITUTE OF SIDDHA
OP NUMBER 5
TAMBARAM SANATORIUM
CHENNAI 47
Kancheepuram
TAMIL NADU |
8508973365
drgracy10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
saya chooranam |
for tonsillitis
dosage for children: 500mg twice a day with honey
adults: 1 gram twice a day with honey
duration 48 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
COUGH, FEVER, THROAT PAIN, HOARSENESS OF VOICE, TASTELESSNESS, DYSPNOEA |
|
| ExclusionCriteria |
| Details |
THROAT CANCER, COPD, BRONCHITIES, VULNERABLE GROUP, PREGNANCY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFICACY OF SIDDHA POLYHERBAL FORMULATION SAYA CHOORANAM |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE THE SAFETY OF SIDDHA POLY HERBAL FORMULATION SAYA CHOORANAM |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2019 |
| 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
|
PUBLISHED AFTER COMPLETION OF STUDY |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS STUDY DEALS WITH INFECTION OF ADENOID AND TONSILLS. SAYA CHOORANAM IS A POLY HDERBAL FORMULATION TO CURE TONSILLITIES WITHOUT INTERVENTION OF SURGERY. |