| CTRI Number |
CTRI/2022/11/047215 [Registered on: 11/11/2022] Trial Registered Prospectively |
| Last Modified On: |
09/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
CLINICAL EVALUATION OF SIDDHA MEDICINE SEVVIYADHI CHOORANAM FOR THE MANAGEMENT OF AZHAL THALAINOKKADU (SINUSITIS) |
|
Scientific Title of Study
|
PHASE II NON RANDOMISED OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE SEVVIYADHI CHOORANAM FOR THE MANAGEMENT OF AZHAL THALAINOKKADU (SINUSITIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SSHAMSHALNIHA |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
| Address |
POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI
Chennai
TAMIL NADU
600106
India |
| Phone |
9092790001 |
| Fax |
|
| Email |
nihaasiddha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANBU N |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PG POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S SHAMSHALNIHA |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
| Address |
POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI
Chennai
TAMIL NADU
600106
India |
| Phone |
9092790001 |
| Fax |
|
| Email |
nihaasiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT SIDDHA MEDICAL COLLEGE,ARUMBAKKAM, CHENNAI |
|
|
Primary Sponsor
|
| Name |
SSHAMSHALNIHA |
| Address |
DEPARTMENT OF PG POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI |
| 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 |
| DrSSHAMSHALNIHA |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
ROOM NO.S1,DEPARTMENT OF PG POTHU MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM
Chennai
TAMIL NADU |
9092790001
nihaasiddha@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: J014||Acute pansinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
SEVVIYADHI CHOORANAM |
2grams(two times a day) with jaggery for 48 days(Oral route of administration) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Rhinorrhoea Head ache Pain and tenderness over Paranasal sinus Nasal congestion |
|
| ExclusionCriteria |
| Details |
Rhinorrhoea Head ache Pain and tenderness over Paranasal sinus Nasal congestion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome will be mainly assessed by reduction in clinical symptoms after the treatment and assessing the improvement of the patient from severe to moderate, moderate to mild through ADELAIDE Symptom Severity Score which helps to ensure the wellness of the patient.
|
Within a period of 48 days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms will be assessed |
WITHIN A PERIOD OF 48 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)
|
15/11/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sinusitis is the inflammation of sinuses, which are air filled cavities in the skull. It can be acute or chronic. Types of sinuses are maxillary, frontal,ethmoid and sphenoid. The maxillary sinuses are mostly involved. The condition in which all the sinuses involved is called Pansinusitis.In Siddha system of medicine there are many unique combination of medicines which have solution to present scenario of Sinusitis. One such combination is SEVVIYADHI CHOORANAM which will be cost effective and reliable. The method of preparation of medicine is easy and raw drugs are easily available.
The aim of this study is the management of AZHAL THALAINOKKADU( SINUSITIS) with the Siddha medicine SEVVIYADHI CHOORANAM and the objective is to determine the therapeutic efficacy and safety profile of Siddha medicine SEVVIYADHI CHOORANAM in the treatment of AZHAL THALAINOKKADU (SINUSITIS).
The ingredients of the formulation used for current study posses various pharmacological activities. As the literary evidences support the usage of drugs in the disease,hypothesis is created in such a way that the efficacy of SEVVIYADHI CHOORANAM will be better solution for the management of AZHAL THALAINOKKADU (SINUSITIS) |