OQ19 for Adult Chronic Inflammatory Lung Diseases

Phase 4

Conditions: Health Condition 1: J709- Respiratory conditions due to unspecified external agent

Registration Number: CTRI/2023/01/049001

Lead Sponsor: Kartikey Exploration Mining Services Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Screened participants with ‘Yes’ answer to all the following questions will be eligible to take part in the study:

1)Those having chronic inflammatory lung disease identified (CILD)as follows - mild, moderate and severe symptoms(not lung function tests) as shown in the below asthma severity table since a month; patients notified by the pulmonologist or physicians to the study staff as CILD; cough more than four weeks and history of use of bronchodilators presumed to have CILD.

2)People willing to give their consent to participate in the study

3)People residing in and around Chandrapur

4)Male or non-pregnant female adult =18 years of age at time of enrollment

5) No contraindications to NOQ19 – Ayurvedic Proprietary Medicine/any herbal medicine, such as allergy or have history of severe gastritis or peptic ulcer.

Exclusion Criteria

Screened patients with ‘Yes’ answer to any of the following questions will not be eligible to participate in the study:

1)Patients of CILD with co-morbidities such as heart diseases, renal disease, hepatic diseases, cancer, autoimmune diseases or neurological diseases or other infectious disease like Tuberculosis etc.

2) Lactating mothers and pregnant women

3)Patients on other therapies (homeopathic, Siddha, Ayurveda or any other prescribed Ayurveda drug) along with the trial drug and not willing for the trial herbal drug

4)Treating physician considers the patient unfit to administer the intervention

5)History of recent severe gastritis, peptic ulcer or hematemesis

6)Enrolled in another trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in the scores of quality of life measured by the St. George’s Respiratory Questionnaire(SGRQ)Timepoint: At baseline (day 0) and endline (day 90) for both the treatment periods

Secondary Outcome Measures

Name	Time	Method
1)Improvement in Lung functions – FeV1/VC <br/ ><br>2)Improvement in levels of Immunoglobulin E (IgE) and C Reactive Protein(CRP) <br/ ><br>Timepoint: At day 0, day 45 and day 90 of both the treatment periods