| CTRI Number |
CTRI/2022/11/047331 [Registered on: 15/11/2022] Trial Registered Prospectively |
| Last Modified On: |
15/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Combination of Nellivatral chooranam and Yoga therapy for Neerpeenism (Sinusitis) |
|
Scientific Title of Study
|
PHASE II - NON RANDOMIZED COMPARATIVE OPEN CLINICAL EVALUATION ON "NEERPEENISM"(SINUSITIS) TREATED WITH SIDDHAR YOGA THERAPY AND INTERNAL NELLIVATRAL CHOORANAM. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manikandan U |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
post graduate,Room no S3,Department of siddhar yoga maruthuvam,Government Siddha Medical College,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9962428486 |
| Fax |
|
| Email |
drmanikandan1402@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saibudeen K |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate,Head of the Department,Department of Siddhar Yoga Maruthuvam,Government Siddha Medical College,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9486041993 |
| Fax |
|
| Email |
drsaibudeen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manikandan U |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate,Room no S3,Department of siddhar yoga maruthuvam,Government Siddha Medical College,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9962428486 |
| Fax |
|
| Email |
drmanikandan1402@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College,Chennai. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
6,Anna arch road,NSK Nagar, Arumbakkam,Chennai - 600106 |
| Type of Sponsor |
Government medical college |
|
|
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 Manikandan U |
Government Siddha Medical College |
Post graduate, Room no S3, Department of Siddhar Yoga Maruthuvam, Government Siddha Medical College,Arumbakkam, Chennai.
Chennai
TAMIL NADU |
9962428486
drmanikandan1402@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: J019||Acute sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nellivatral chooranam with Yoga therapy |
Nellivatral chooranam - powder form
ASANAM
Bhujangasanam - 3minutes
Ustrasanam - 3minutes
Savasanam - 3minutes PRANAYAMAM
Nadisudhi pranayamam - 3 min
Bhastrika pranayamam -3 min DHIYANAM
Aum chanting - 5 minutes
Duration : 48 days |
| Comparator Agent |
Yoga therapy |
ASANAM
Bhujangasanam - 3minutes
Ustrasanam - 3minutes
Savasanam - 3minutes PRANAYAMAM
Nadisudhi pranayamam - 3 min
Bhastrika pranayamam - 3 min DHIYANAM
Aum chanting - 5 minutes
Duration : 48 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Running nose,Headache,Heaviness of head,Nasal congestion,pain and tenderness over PNS area,Recurrent sneezing. |
|
| ExclusionCriteria |
| Details |
TB with sinusitis, Epistaxis, Bronchial asthuma, Ophthalmic headache, congenital anomalies, Malignancy of PNS, Pregnant women and Lactating mother,Any other serious systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Paranasal pain. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce heaviness of head/headache,Sneezing,Nasal block. |
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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Non - Randomized comparative open clinical trial to study the safety and efficacy of siddha trial drug Nellivatral chooranam (internal) and siddhar yoga therapy. Siddhar yoga therapy is given to 20 patients (group - 1) for 48 days. For group 2 patients (20 in numbers) Internal medication Nellivatral chooranam in a dosage of 2g twice a day along with siddhar yoga therapy is to be given for 48 days. |