| CTRI Number |
CTRI/2025/09/093992 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate the Efficacy and Safety of Koff-N-Cold Tablets in Mild to Moderate COVID-19 Positive Participants |
Scientific Title of Study
Modification(s)
|
An open label, single arm, single-center and prospective pilot study to evaluate the efficacy and
safety of Koff-N-Cold tablets in Mild to Moderate COVID-19 Positive Participants |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| IR-CT-COV-2025 version 2.0 dated 27-Aug-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himanshu Shukla |
| Designation |
Principal Investigator |
| Affiliation |
PGH Hospital Private Limited |
| Address |
Clinical research room, room no. 2, Department of medicine, ground floor, Plot No. 89A, Vikasnagar Extn Phase-2, Shukkar Bazar Rd, Block B, Uttam Nagar, New Delhi, Pin- 110059, India
New Delhi
DELHI
110059
India |
| Phone |
9999461089 |
| Fax |
|
| Email |
himanshu502000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Founder and Managing Director |
| Affiliation |
IR Innovate Research Pvt. Ltd. |
| Address |
Building C-120, Third Floor
Sector - 2, Noida, 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Founder and Managing Director |
| Affiliation |
IR Innovate Research Pvt. Ltd. |
| Address |
Building C-120, Third Floor
Sector - 2, Noida, 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| Greenspace
Unit No. 0401N, 4th Floor, Beacon Tower-2, Brigade Twin Towers, No. 11/1-4, Jai Bharath Industries Pipeline Road, Yeshwanthpur, Bengaluru-560 022. |
|
|
Primary Sponsor
|
| Name |
Greenspace |
| Address |
Unit No. 0401N, 4th Floor, Beacon Tower-2, Brigade Twin Towers, No. 11/1-4, Jai Bharath Industries Pipeline Road, Yeshwanthpur, Bengaluru-560 022. |
| Type of Sponsor |
Other [Nutraceutical] |
|
|
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 Himanshu Shukla |
PGH Hospital Pvt. Ltd. |
Clinical research room, room no. 2, Department of medicine, ground floor, Plot No. 89A,Vikasnagar Extn Phase-2, Shukkar Bazar Rd, Block B, Uttam Nagar, New Delhi, Pin - 110059, India
New Delhi
DELHI |
9999461089
himanshu502000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J168||Pneumonia due to other specified infectious organisms. Ayurveda Condition: SVASA-UPADRAVA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tulasi , Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 90(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial
investigates a herbo-nutraceutical formulation
containing traditional Ayurvedic ingredients | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vasaka, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 60(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial
investigates a herbo-nutraceutical formulation
containing traditional Ayurvedic ingredients | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 80(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic ingredients | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 70(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic ingredients | | 5 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridra, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic ingredients |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female aged 18–65 years.
2. Participants with confirmed COVID-19 (RT-PCR positive) with mild to moderate symptoms (RT-PCR positive report will be accepted within 72
hours prior to screening)
3.Participants with symptom onset within the past 5 days.
4.Participants with Oxygen saturation (SpO2) greater than 94 percent on room air.
5.Willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Participants with any of the following conditions will be excluded from the study.
1.Participants with severe COVID-19 requiring hospitalization.
2.Pregnant or breastfeeding women.
3.Participants with history of hypersensitivity to any herbal components.
4.Concurrent participation in another clinical trial.
5.Participants with any co-morbid conditions.
6.Participants with chronic respiratory diseases requiring daily medication.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Covid-19 symptoms like Fever,Vomiting, Nausea, Diarrhea, sense of smell, sense of taste, etc. as per COVID-19 questionnaire. |
Time Frame: Day 1, Day 3, Day 5, Day 7 & Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary endpoints is to evaluate the-
1.Time of complete resolution of cough, sore throat, & nasal congestion.
2.Requirement of rescue medications.
3.Incidence of adverse events during the study period. |
From baseline i.e., Day 01 to Day 15 |
|
|
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)
|
09/08/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, has posed significant challenges to global health since its emergence. While vaccines and various therapeutic agents have been developed, the search for safe and effective treatments—particularly for mild to moderate cases—remains ongoing to reduce symptom burden and disease progression.
Koff-N-Cold tablets, a polyherbal formulation traditionally used for the management of upper respiratory tract infections, possess potential antiviral, anti-inflammatory, and immunomodulatory properties. Given their pharmacological profile, Koff-N-Cold tablets may offer supportive treatment benefits in managing COVID-19-related symptoms.
This open-label, single-arm, single-center, and prospective study is designed to evaluate the efficacy and safety of Koff-N-Cold tablets in COVID-19 positive participants with mild to moderate symptoms. The findings may contribute to the evidence base for integrating supportive herbal formulations in the clinical management of COVID-19. |