| CTRI Number |
CTRI/2023/03/050708 [Registered on: 15/03/2023] Trial Registered Prospectively |
| Last Modified On: |
14/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical
Study to Evaluate the Safety and Efficacy of NIOX-G
Ayurvedic Nasal Spray against Upper Respiratory Tract Viral
infections in Vaccinated/ Unvaccinated adult Patients |
|
Scientific Title of Study
|
A prospective, two-arm, single blind, single centre, Clinical
Study to Evaluate the Safety and Efficacy of NIOX-G
Ayurvedic Nasal Spray against Upper Respiratory Tract Viral
infections in Vaccinated/ Unvaccinated adult Patients as a curative measures and as a management of Respiratory
Allergies & Acute Sinusitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KTPL/NG/CT/2022/01 Version 01 Dated 05 Jul 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Sunil Naik |
| Designation |
M.D., General Medicine |
| Affiliation |
Government Medical College and Government General Hospital |
| Address |
Room No 13, First Floor Department of Medicine, OPD Block
Government Medical College and Government General Hospital
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8942279033 |
| Fax |
|
| Email |
drsunilnaikggh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K G Padmanabhan |
| Designation |
Medical Monitor |
| Affiliation |
Khoday Trading Private Limited |
| Address |
Room No 03, Ground Floor Brewery House, 7th Mile, Kanakapura Road, Bangalore
Bangalore
KARNATAKA
560062
India |
| Phone |
08040934216 |
| Fax |
|
| Email |
pady72@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K G Padmanabhan |
| Designation |
Medical Monitor |
| Affiliation |
Khoday Trading Private Limited |
| Address |
Room No 03, Ground Floor Brewery House, 7th Mile, Kanakapura Road, Bangalore
Bangalore
KARNATAKA
560062
India |
| Phone |
08040934216 |
| Fax |
|
| Email |
pady72@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Khoday Trading Private Limited
Brewery House, 7th Mile, Kanakapura Road,
Bangalore, Karnataka, India.
Pin Code: 560062 |
|
|
Primary Sponsor
|
| Name |
Khoday Trading Private Limited |
| Address |
Brewery House, 7th Mile, Kanakapura Road,
Bangalore, Karnataka, India.
Pin Code: 560062 |
| Type of Sponsor |
Other [Herbal] |
|
|
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 K Sunil Naik |
Government Medical College & Government General Hospital |
Department of General
Medicine, Room No 13,
First Floor, OPD
Block
Srikakulam
ANDHRA PRADESH |
8942279033
drsunilnaikggh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Government Medical College & Government General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J019||Acute sinusitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: NIOX-G, Reference: NA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 0.2(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all study procedures.
2. Male or Female subjects aged between 18 to 65 years (both inclusive).
3. Subjects with Upper Respiratory Tract Viral infections/ Respiratory Allergies (Allergic Rhinitis) / Acute Sinusitis.
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at
screening visit. |
|
| ExclusionCriteria |
| Details |
1. Subjects with any history of underlying uncontrolled medical illness (such as diabetes, hypertension, liver disease or history of
alcoholism, HIV, chronic hepatitis B, hepatitis C Infection or any other serious medical illness).
2. Subjects who are receiving corticosteroids (in a dose equivalent to ≥ 20 mg prednisone per day), immunosuppressive radiation therapy, or cytotoxic agents.
3. Females who are breastfeeding, pregnant, or attempting to become pregnant.
4. Patients who had undergone nasal surgery within the previous 6 months
5. Patients with nasal polyps, significant deviation of the nasal septum or significant nasal tract structural malformation.
6. Patients with a history of chronic sinusitis, asthma or any other condition that can interfere with the aim of the study.
7. Subjects who have any other condition that, in the opinion of the Investigator, would interfere with a participant’s ability to adhere to the protocol (e.g., participants who are mentally or
neurologically disabled and who are considered not fit to their participation in the study), interfere with assessment of the
investigational product, or compromise the safety of the participant or the quality of the data.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean Nasal symptoms score (NSS) |
Day 1 to Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in mean Nasal symptoms score (NSS) |
Day 1 to Day 7 |
| Investigators global clinical impression (CGI) |
At Day 14 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/03/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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)?
Response - NO
|
|
Brief Summary
|
This is a prospective,single blind, single centre, Clinical Study to Evaluate the Safety and Efficacy of NIOX-G Ayurvedic Nasal Spray against Upper Respiratory Tract Viral infections in Vaccinated/ Unvaccinated adult Patients. The study consists of 2 Arms in which 1 arm will receive the standard therapy along with NIOX-G and another arm will receive standard therapy and placebo |