CTRI/2021/08/036089 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On:
07/01/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical Study on Lupin’s Ayurvedic Nasal Spray in COVID-19 patients and household contacts
Scientific Title of Study
Multi-center, randomized, parallel-group, comparative, open-label study to evaluate the efficacy and safety of Lupin’s Ayurvedic Nasal Spray in subjects diagnosed with COVID-19 and household contacts
Noscovic/Lupin/2021, Version 2.0, Dated 27th Aug 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pranita Joshi Deshmukh
Designation
Associate Professor
Affiliation
MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra, Malwadi, Hadapsar, Pune
Address
Dept. of Kriyasharir
HOD, Dept. of Research Methodology and Bio-statistics
OPD No. 2, Ground Floor, MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra, Malwadi, Hadapsar, Pune
Pune MAHARASHTRA 411028 India
Phone
9822229579
Fax
Email
pranitaj@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research
Address
Target Institute of Medical Education and Research
A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban) MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Details of Contact Person Public Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research
Address
Target Institute of Medical Education and Research
A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Source of Monetary or Material Support
Lupin Ltd. 3rd Floor
Kalpataru Inspire Bldg., Opp. Hotel Grand Hyatt, Santacruz-East. Mumbai-400055
Primary Sponsor
Name
Lupin Ltd
Address
3rd Floor, Kalpataru Inspire Bldg., Opp. Hotel Grand Hyatt, Santacruz-East. Mumbai-400055
OPD No.1, Ground floor, Department of Kayachikitsa, JSS Ayurveda Medical College, Lalithpura Road, Mysore, Karnataka -570028 Mysore KARNATAKA
9538367282
drpbsreddy@yahoo.com
Dr Narendrakumar B Mundhe
KVTR Ayurvedic College and Hospital
Department of Kayachikitsa,
OPD No. 5, Ground Floor, Department of Kayachikitsa, KVTR Ayurvedic College Boradi, Tal. Shirpur, Dist. Dhule-425428
Dhule MAHARASHTRA
9850378206
drnbmundhe@gmail.com
Dr Pranita Joshi Deshmukh
MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra
Associate Professor, Dept. of Kriyasharir HOD, Dept. of Research Methodology and Bio-statistics OPD No. 2, Ground Floor, MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra, Malwadi, Hadapsar, Pune 411028 Pune MAHARASHTRA
9822229579
pranitaj@gmail.com
Dr Rajeshwar Reddy
RA Podar Ayurvedic Medical College and M A Podar Hospital
Shalya Tantra Department, Ground floor, RA Podar Ayurvedic Medical College and M A Podar Hospital, Dr Annie Besant Rd, Worli, Mumbai, Maharashtra 400018
Mumbai MAHARASHTRA
Institutional Ethics Committee, RA Podar Ayurvedic Medical College and M A Podar Hospital, Worli, Mumbai
Approved
Institutional Review Board For Research, MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra, Malwadi, Hadapsar, Pune
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:B972||Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: SANNIPATAJAJVARAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Drug
Other than Classical
(1) Medicine Name: Lupin’s Ayurvedic Nasal Spray, Reference: NA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to use Lupin’s Ayurvedic Nasal Spray for 14 days (one spray per nostril 5 times a day in treatment group & one spray per nostril 3 times a day in prevention group). Standard of Care (SOC) will be allowed as per investigator’s discretion or institutional protocol or guideline released by Ministry of health and family welfare, Government of India.
2
Comparator Arm (Non Ayurveda)
-
Control nasal spray (saline nasal spray)
Subjects will be asked to use Control nasal spray (saline nasal spray) for 14 days (one spray per nostril 5 times a day in treatment group & one spray per nostril 3 times a day in prevention group). Standard of Care (SOC) will be allowed as per investigator’s discretion or institutional protocol or guideline released by Ministry of health and family welfare, Government of India.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
1. Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol.
2. Subjects with mild COVID-19 symptoms (only for Treatment Group). Subjects with uncomplicated upper respiratory tract infection (without shortness of breath or hypoxia [normal saturation i.e. SpO2 levels ≥94%]), may have mild grade of fever (<1000 C), cough, sore throat, nasal congestion, malaise and headache.
3. Participants staying with COVID-19 subject in the same household (only for Prevention Group).
4. Participants who have tested positive for RT-PCR (for treatment group only) and negative for RT-PCR (for prevention group only) within 5 days of enrollment
ExclusionCriteria
Details
1. Subjects with moderate to severe disease
2. Subjects requiring or likely requiring oxygen support in the opinion of investigator
3. Any clinical contraindications, as judged by the investigator
4. Pregnant or lactating females
5. Subjects with prior history of confirmed COVID-19 infection with RT-PCR in last 3 months.
6. Subjects who are currently hospitalized or need for hospitalization
7. Subjects with blocked nose requiring intranasal decongestant
8. Any history of underlying uncontrolled medical illness (such as diabetes, hypertension, liver disease or history of alcoholism, HIV or any other serious medical illness)
1. Change in SARS-CoV-2 viral load from baseline to day 2, day 4, day 7 and 14 (measured by RT-PCR/q-PCR) in treatment group.
2. Proportion of subjects with viral negativity measured by RT-PCR on day 14 in prevention group
Screening Visit (Up to 5 days), Baseline Visit (Day 0), Day 2, Day 4, Day 7, and day 14.
Secondary Outcome
Outcome
TimePoints
1. No of days required for complete clinical recovery and Proportion of patients with complete clinical recovery
2. Safety and tolerability in terms of adverse events, serious adverse events
Screening Visit (Up to 5 days), Baseline Visit (Day 0), Telephonic follow up (Day 2 to day 6), Day 7, Telephonic follow up (Day 8 to Day 13) and day 14.
Target Sample Size
Total Sample Size="150" Sample Size from India="150" Final Enrollment numbers achieved (Total)= "138" Final Enrollment numbers achieved (India)="138"
A multi-center, randomized, parallel-group, comparative, open-label study was conducted to evaluate the efficacy and safety of Lupin’s Ayurvedic Nasal Spray in subjects diagnosed with COVID-19 and household contacts. The study was carried out at 6 centers in India. All enrolled subjects were divided into 2 groups as per computer generated randomization list i.e. treatment group and prevention group. Subjects suffering from mild symptoms of newly discovered coronavirus disease (COVID-19) were enrolled in treatment group. Subjects who were household contacts with patients of newly discovered coronavirus disease and tested negative were included in the prevention group. Subjects from treatment group were randomly allocated (in 2:1 ratio) to either active treatment arm i.e. Lupin’s Ayurvedic Nasal Spray and Standard of care (SOC) or control arm i.e. Control nasal spray (saline nasal spray) and SOC. SOC was provided as per the applicable guidelines of ICMR/Local Health Authority and as per investigator’s discretion. All enrolled subjects allocated to receive Lupin’s Ayurvedic Nasal Spray were administered with Lupin’s Ayurvedic Nasal Spray, one spray per nostril for 5 times a day for 14 days. All enrolled subjects allocated to receive Control nasal spray (saline nasal spray) were administered with Control nasal spray (saline nasal spray), one spray per nostril for 5 times a day for 14 days.
Subjects from preventive group were randomly allocated (in 2:1 ratio) to either active treatment arm i.e. Lupin’s Ayurvedic Nasal Spray and SOC/standard preventive measures or control arm i.e. Control nasal spray (saline nasal spray) and SOC/standard preventive measures. All enrolled subjects allocated to receive Lupin’s Ayurvedic Nasal Spray were administered with Lupin’s Ayurvedic Nasal Spray, one spray per nostril for 3 times a day for 14 days. All enrolled subjects allocated to receive Control nasal spray (saline nasal spray) were administered with Control nasal spray (saline nasal spray), one spray per nostril for 3 times a day for 14 days
The primary objectives of the study were to assess change in SARS-CoV-2 viral load from baseline to day 2, day 4, day 7 and 14 (measured by RT-PCR/q-PCR) in treatment group and proportion of subjects with viral negativity measured by RT-PCR on day 14 in prevention group. The secondary objectives were to assess number of days required for complete clinical recovery and proportion of patients with complete clinical recovery and safety and tolerability in terms of adverse events, serious adverse events on screening visit (Up to 5 days), baseline visit (Day 0), telephonic follow up (Day 2 to day 6), Day 7, telephonic follow up (Day 8 to Day 13) and day 14.
Results:
This study conducted on an approved Ayurvedic Nasal Spray of Lupin (Noxguard) has been completed. There was a faster and significant reduction in the baseline viral load after treatment with Noxguard nasal spray in COVID-19 patients. Significantly higher proportion of patients treated with Noxguard achieved viral negativity (as measured by RT-PCR) by day 4 and 7 compared to patients treated with control (saline) nasal spray. None of the patients treated at home with Noxguard required hospitalization versus 12% of patients treated with control (saline) nasal spray. None of the close contacts of COVID-19 patients in the prevention cohort contracted infection after treatment with Noxguard versus 9.1% in control (saline) nasal spray group. Use of Noxguard nasal spray was found to be safe and well-tolerated for the treatment of COVID-19 patients and for post-exposure prophylaxis of close contacts of COVID-19 patients.