| CTRI Number |
CTRI/2025/07/089984 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Proof of Concept, Randomized, Double Blind, Placebo Controlled Clinical Trial to Assess the Effect of GH-LS-R1 on Respiratory Health. |
|
Scientific Title of Study
|
A Proof of Concept, Randomized, Double Blind, Placebo Controlled Clinical Trial to Assess the Effect of GH-LS-R1 on Respiratory Health and Quality of Life in Individuals Exposed to High Pollution. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIO/012025/RH/GH/001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Kamble |
| Designation |
Principal Investigator |
| Affiliation |
Jejurikar’s Health Care |
| Address |
Jejurikar’s Health Care
Shop No-7, Office No-8, Krishna Niwas CHS, 14, Sane Guruji Road Shivaji Nagar, B-cabin, opp. TBZ, Naupada, Thane West, Mumbai, Maharashtra 400602.
Thane
MAHARASHTRA
400602
India |
| Phone |
9969372341 |
| Fax |
|
| Email |
sagark8688@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Srivastava |
| Designation |
Executive Director |
| Affiliation |
BioAxion Innovations |
| Address |
No. 301, Tropical Business Park Opp ESIS Kamagar Hospital, Road No. 33, Wagle Industrial Estate, Thane West, Thane, Maharashtra 400604
Thane
MAHARASHTRA
400604
India |
| Phone |
9004877885 |
| Fax |
|
| Email |
dr.shalini@bioaxion.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Ghosh |
| Designation |
Sr. Manager - Clinical Operations |
| Affiliation |
BioAxion Innovations |
| Address |
No. 301, Tropical Business Park Opp ESIS Kamagar Hospital, Road No. 33, Wagle Industrial Estate, Thane West, Thane, Maharashtra 400604
Thane
MAHARASHTRA
400604
India |
| Phone |
7718077885 |
| Fax |
|
| Email |
dr.sonalig@bioaxion.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Verisearch Lab |
| Address |
Quantum Towers, 705, Rambagh Lane, Malad, Nadiyawala Colony 2, Malad West, Mumbai, Maharashtra 400064 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BioAxion Innovations |
No. 301, Tropical Business Park Opp ESIS Kamagar Hospital, Road No. 33, Wagle Industrial Estate, Thane West, Thane, Maharashtra 400604 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sagar Kamble |
Jejurikars Health Care |
Department of Medicine, Room No-8, Krishna Niwas CHS, 14, Sane Guruji Road Shivaji Nagar, B-cabin, opp. TBZ, Naupada, Thane West, Mumbai, Maharashtra 400602.
Thane
MAHARASHTRA |
9969372343
sagark8688@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Respiratory Health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GH-LS-R1 (Mucilage Rich Supplement) |
Dietary Supplement for improvement in lungs functioning |
| Comparator Agent |
Mycrocrytalline Cellulose |
Placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals working outdoors for more than equal to 2 years with at least 8 hours of working time in pollution heavy area.
Systolic blood pressure less than equal to 140. Diastolic blood pressure less than equal to 90.
Individuals with complains of one or more of the listed respiratory problems which includes cough, breathlessness, fatigue and/or sneezing due to exposure to pollution, at least once every 2 weeks.
Individuals with FEV1 by FVC ratio greater than equal to 0.5 and less than equal to 0.7.
Individuals with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.
RBC count Less than normal (Normal Value Male 4.5 to 6.5 mil by cmm; Female 4 to 5.4 mil by cmm)
|
|
| ExclusionCriteria |
| Details |
Individuals with FEV1 by FVC ratio less than 0.5.
History of gastroenteritis in the past month
Usage of hormones and steroids in 60 days before entering the study.
Usage of antibiotics in 15 days before entering the study.
Usage of nasal spray or other probiotics (such as lactic acid bacteria, Bifidobacterium) in the last one month.
Lymph node enlargement, inflammation, polyps, mass, runny nose, etc., after clinical examination of lips, throat, ears, nostrils, and neck
Clinically significant GI condition (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose and gluten intolerance or allergies). Recent (within 2 weeks of screening) history of an episode of acute GI illness such as nausea/vomiting or diarrhoea (defined as greater than equal to 3 loose or liquid stools/day)
Individuals with history of gastrointestinal surgery
Long history of drug use
Individuals with history of smoking in the past 5 years or currently smoking or using any form of tobacco.
Post-menopausal women
Pregnant and/ or lactating females
Inability to understand and cooperate with the study process.
Participated in other clinical trials within the past month.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the lung’s capacity as indicated by higher increase in the Tiffeneau-Pinelli index (FEV1/FVC ratio) from baseline to EOS, as compared to placebo.
|
Day 0 to Day 28 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| Date of Study Completion (India) |
20/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized, double-blind, placebo-controlled clinical trial evaluating the effect of a GH-LS-R1 on respiratory health. The study includes healthy adults aged 18–60 who are frequently exposed to high levels of air pollution and report related breathing symptoms. Participants will take one capsule daily for 28 days and undergo assessments like lung function tests, stool pH, hydration status, and symptom questionnaires.
The study aims to measure improvements in lung capacity, symptom relief, gut health, and overall hydration. Safety will be monitored through vital signs, blood tests, adverse event tracking, and regular medical check-ups. |