| CTRI Number |
CTRI/2025/03/083237 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study to test the Ethniq Lung Detox Bars and Paste for Better Lung Health |
|
Scientific Title of Study
|
An Open-Label, Two-Arm, Multi-Centered Clinical Study To Evaluate The Safety And Efficacy Of Ethniq Lung Detox Bars And Paste In Subjects For Lung Health. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2425 Version No. 1.0 Dated 04/Dec/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Arpita Malgi |
| Designation |
Trial Coodinator and Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block,
Bangalore
KARNATAKA
560091
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi L M |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main,Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Ethniq Ayush Exports LLP
D-179, Phase-8b, Sector 74,
Chandigarh Sector 55, Rupnagar, S.a.s.nagar(Mohali),
Punjab, India, 160055.
|
|
|
Primary Sponsor
|
| Name |
Ethniq Ayush Exports LLP |
| Address |
D-179, Phase-8b, Sector 74,
Chandigarh Sector 55, Rupnagar,S.a.s.nagar(Mohali),
Punjab, India, 160055.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sambashiva |
Sri Lakshmi Super Speciality Hospital |
#301 3rd main road, Old Extension
KR Puram, Bangalore-560036
Bangalore
KARNATAKA |
6364898825
drsambashiva.sl@gmail.com |
| Dr Indushree |
Upadhya Ayurveda Bhandar |
Near Srirampura Metro Station
No. 38, MKK Road, Srirampura,
Bangalore
Bangalore
KARNATAKA |
7892275168
drbsindushree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R05||Cough. Ayurveda Condition: PRANAVAHASROTOVIDDHA, (2) ICD-10 Condition:R060||Dyspnea. Ayurveda Condition: PRANAVAHASROTOVIDDHA, (3) ICD-10 Condition:R062||Wheezing. Ayurveda Condition: PRANAVAHASROTOVIDDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Breathe Max Bar, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -Arm A – Breathe Max Bar: This product will be given to 25 participants in each indication (Chronic Cough, Bronchitis, Asthma, and Lung Detox). The treatment will last for 90 days, and participants will consume one Breathe Max Bar daily throughout the study. | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Respi Revive (Alveha), Reference: NA, Route: Oral, Dosage Form: Kalka/ Paste, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -Arm B – Respi Revive (Alveha)-This product will be given to 25 participants in each indication (Chronic Cough, Bronchitis, Asthma, and Lung Detox). The treatment will last for 90 days, and Participants will consume 1 teaspoon of Ethniq Lung Detox Paste in the morning and 1 teaspoon in the evening after meals for the entire study duration. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 65 years
2. Respiratory symptoms include participants presenting with mild to moderate symptoms such as coughing, wheezing, or shortness of breath.
3. Participants with mild to moderate asthma should have an ACT score of 16 or higher and an FEV1 of 60 percent or higher to ensure the inclusion of controlled asthma cases.
4. Eligible participants include those with chronic cough, bronchitis, mild asthma, or those seeking lung detoxification support.
5. Participants must be willing to provide informed consent and adhere to the study protocol. |
|
| ExclusionCriteria |
| Details |
1. Diagnosed with severe chronic respiratory diseases such as COPD or severe asthma requiring urgent medical care or long-term medication.
2. Respiratory conditions that required hospitalization within the past six months.
3. ACT score below 16, GOLD Stage 3 or 4 for COPD, or dependency on systemic steroids or oxygen therapy.
4. Severe cardiovascular diseases, including a heart attack or stroke within the past year.
5. Known allergy or hypersensitivity to any ingredient in the Lung Detox Bars or Paste.
6. Pregnant or breastfeeding women.
7. Severe mental illness or conditions that may affect compliance with the study protocol.
8. Use of investigational drugs or devices within 30 days prior to the study.
9. Severe comorbidities that may interfere with study outcomes or participant safety. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Lung Function (Relative to Baseline):
PFT Parameters: Increase in lung volume, vital capacity, and tidal volume.Spirometry Metrics: Improvement in FEV1, FVC, and FEV1/FVC ratio.
|
Day 0, Day 30, Day 45, Day 60 and Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Chronic Cough: Reduction in severity and frequency, as measured by the Leicester Cough Questionnaire and Visual Analog Scale (VAS).
2. Bronchitis: Improvement in bronchial comfort and reduction in sputum production.
3. Asthma: Improved symptom control, as assessed by the Asthma Control Test (ACT) and spirometry metrics (e.g., FEV1).
4. Lung Detox: Improved blood oxygen saturation (SpO2) and participant-reported detox-related outcomes.
|
Day 0, Day 30, Day 45, Day 60 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
01/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
BACKGROUND AND INTRODUCTIONRespiratory health is increasingly affected by pollution, smoking, and occupational exposure, leading to conditions like chronic cough, bronchitis, and mild asthma. While herbal remedies like Vasa, Mulethi, and Pippali show potential benefits, clinical evidence is limited. This study evaluates the safety and efficacy of Ethniq Lung Detox Bars and Paste in improving lung health. The formulations contain: - Vasa (Adhatodavasica): Bronchodilator and anti-inflammatory.
- Mulethi (Glycyrrhizaglabra): Expectorant and respiratory soother.
- Pippali (Piper longum): Reduces airway resistance.
Key outcomes include reduced cough, improved bronchial comfort, better asthma symptom control, and enhanced lung detoxification. PURPOSE OF THE STUDY This study aims to evaluate the safety and efficacy of Ethniq Lung Detox Bars and Paste in improving lung health and managing mild to moderate respiratory conditions, including chronic cough, bronchitis, and mild asthma. The study will assess their impact on cough severity, bronchial comfort, lung function, and detoxification to provide clinical evidence supporting their use. |