se of Roselle in Bronchial asthma and Malnutritio

Phase 2

Completed

• Conditions: Health Condition 1: J454- Moderate persistent asthma

• Registration Number: CTRI/2020/08/027013
• Lead Sponsor: DXN Manufacturing India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Patients aged 18-59 years(both sex) suffering from mild and moderate-persistent bronchial asthma characterized by

-Daily symptoms of asthma

-Nocturnal awakenings more than once per week

-Daily need for SABAs for symptom relief

-More than just minor limitation in normal activity

-FEV1 between 60 and 80 percent of predicted and an FEV/FVC ratio less than the lower confidence interval for normal

Exclusion Criteria

Patients with fever, drug-induced asthma, aspirin intolerance triad, asthma with fixed airflow limitation, asthma with obesity, late-onset asthma will be excluded.

-History of heart, liver, kidney, or other organ diseases;

-Allergy or intolerance to the individual constituents in NONIZHI

-Subjects who are pregnant and lactating mothers, or with any serious or invalidating other disease limiting full adhesion to the protocol.

-Participation in an investigational drug trial in the 30 days prior to the screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of symptom scores & use of β-agonist, Pulmonary function tests and Absolute Eosinophil counts. <br/ ><br> <br/ ><br>The effect of treatment on symptom scores will be evaluated by analysing average daily symptom scores of treatment on the basis of <br/ ><br>3 categories: daytime symptoms, nocturnal symptoms, and allergic nasal and ocular symptoms. Each category will be scored 0 to 3, with a maximum possible score of 9.Timepoint: week 4, 8 and 12

Secondary Outcome Measures

Name	Time	Method
Evaluation of nutritional status using DETERMINE Your nutritional health <br/ ><br>checklist questionnaire and BMI and mid arm circumferenceTimepoint: week 4, 8 and 12