| CTRI Number |
CTRI/2019/09/021107 [Registered on: 06/09/2019] Trial Registered Prospectively |
| Last Modified On: |
05/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [pugai and nasiyam] |
| Study Design |
Other |
|
Public Title of Study
|
Peenisam (Chronic rhinosinusitis) management with siddha external formulations pugai and nasiyam |
|
Scientific Title of Study
|
An open clinical trial of Siddha external formulations as Pugai and Nasiyam in the treatment of Peenisam (Chronic Rhinosinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr L Nilopher |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai 47
23, apparoa colony
1st street, 1st floor,
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8508627786 |
| Fax |
- |
| Email |
nilochill@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NJ muthukumar |
| Designation |
Head of the department |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9962006843 |
| Fax |
- |
| Email |
njmuthu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L Nilopher |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai 47
23, apparoa colony
1st street, 1st floor,
Tambaram sanatorium
TAMIL NADU
600047
India |
| Phone |
8508627786 |
| Fax |
- |
| Email |
nilochill@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram sanatorium
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
Dr L Nilopher |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai 47 |
| 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 |
| Dr L Nilopher |
Room no 3, Dept of Sirappu Maruthuvam |
Ayothidoss Pandithar Hospital
Kancheepuram
TAMIL NADU |
8508627786
-
nilochill@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J324||Chronic pansinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Pugai and Nasiyam |
Pugai and Nasiyam (external) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Running nose
Facial pain or pressure or fullness
Nasal congestion
sneezing/coughing
headache that is worse in morning, when bending forward
itchy eyes and nose
loss of smell
|
|
| ExclusionCriteria |
| Details |
Common cold
Nasal polyp
Tonsillitis
Migraine
Bronchial asthma
Pulmonary tuberculosis
syphilis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of the study is to relieve the symptoms and it will be assessed by using the validation of the self-questionnaire for assessing the control of allergic rhinitis |
Primary outcome of the study is to relieve the symptoms and it will be assessed by using the validation of the self-questionnaire for assessing the control of allergic rhinitis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
14/09/2019 |
| 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="0"
Months="5"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Therapeutic efficacy of sidindha formulations Pugai and Nasiyam will be assessed by relieving the symptoms in Peenisam (Chronic Rhinosinusitis) and it will be assessed by using the validation of the
self-questionnaire for assessing the control of allergic rhinitis |