| CTRI Number |
CTRI/2019/07/020132 [Registered on: 10/07/2019] Trial Registered Prospectively |
| Last Modified On: |
09/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [curative] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on Nasiyam (Nasal Application) therapy. |
|
Scientific Title of Study
|
A Comparative clinical trial on Therapeutic efficasy of Nasiyam application and Seenthil Choornam in the management of Neerpeenisam(Sinusitis). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrArsha Mohan |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayothidass pandithar hospital, National Institute of Siddha |
| Address |
OP Room No. 3,Dept.of Pura Maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939024492 |
| Fax |
22381314 |
| Email |
aarshamohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N J Muthukumar |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
OP Room No. 3,Dept.of Pura Maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
22381314 |
| Email |
njmuthu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N J Muthukumar |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
OP Room No. 3,Dept.of Pura Maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai-47
Coimbatore
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
22381314 |
| Email |
njmuthu@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Arsha Mohan,2nd year PG Scholar, Dept.of pura Maruthuvam,National Institute of Siddha,Chennai. |
|
|
Primary Sponsor
|
| Name |
DrArsha Mohan |
| Address |
OP Room No. 3,Dept.of Pura Maruthuvam,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 Arsha Mohan |
Ayothidoss Pandithar Hospital |
OP Room No. 3,Dept.of Pura Maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai-47
Kancheepuram
TAMIL NADU |
8939024492
22381314
aarshamohan@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: J010||Acute maxillary sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Seenthil Chooranam and Nasiyam oil |
Group A Drug only,5 gms of powdered drug twice a day for 45 days.
Group B Nasiyam application only, instillation of 2 drops in each nostril for 45 days
Group C Nasiyam and drug group ,for 45 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient suffering from acute and chronic sinusitis
2 Patient with symptoms of headache,watery discharge from nostrils,odour of meat wash,redness of eyes,tenderness on face.
3 Patients willing for investigations.
4 Patient willing to undergo informed consent.
5 patient willing to sign consent stating he or she will conscientiously stick to treatment during 45 days but can opt out of trial of his or her own concious. |
|
| ExclusionCriteria |
| Details |
1 Patient with evidence of Malignancy
2 Patient having tuberculosis or any other respiratory infectious disease
3 History of cardiac diseases
4 History of uncontrolled hypertension
5 History of Chronic kidney diseases
6 Pregnancy and lactation
7 Patient with any other chronic systemic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the therapeutic efficacy of Nasiyam and seenthil chooranam in the management of Peenisam (Sinusitis) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess which kind of patients affect more on Peenisam and their response to trial drug. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/08/2019 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be publish in a reputed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a clinical trial to evaluate the therapeutic efficacy of Nasiyam application on Neer Peenisam (Sinusitis) cases reporting in Ayodidoss Pandithar Hospital of National Institute of Siddha.Acute sinusitis is the second most common infectious diseases seen in general pratice.In the classical text Book of Agasthiyar paripooram -400 menctioned the procedure of Nasiyam for healing Peenisam(Sinusitis).The drugs mentioned in this preparation pocess mostly of hot potency and bitter taste which reduses kabha.
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