Use of Roselle in Bronchial asthma and Malnutrition

Phase 2

Completed

Conditions: Moderate persistent asthma,

Registration Number: CTRI/2020/08/027013

Lead Sponsor: DXN Manufacturing India Pvt Ltd

Brief Summary: The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.

- The selected subjects will receive roselle liquid formulation 30 ml (mixed in 60ml warm water) orally once daily after food for 3 months.

- The patients will be on standard treatment as well for bronchial asthma as per standard guidelines.

The Primary end points of this study will be:

Evaluation of symptom scores & use of Î² -agonist, Pulmonary function tests and Absolute Eosinophil counts.

The effect of treatment on symptom scores will be evaluated by analyzing average daily symptom scores at weeks 4, 8, and 12 of treatment on the basis of 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.

The Secondary end points of this study will be:

Evaluation of nutritional status using DETERMINE Your nutritional health checklist questionnaire and BMI and mid arm circumference will be monitored.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

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 Î²-agonist, Pulmonary function tests and Absolute Eosinophil counts.	week 4, 8 and 12
The effect of treatment on symptom scores will be evaluated by analysing average daily symptom scores of treatment on the basis of	week 4, 8 and 12
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.	week 4, 8 and 12

Secondary Outcome Measures

Name	Time	Method
Evaluation of nutritional status using DETERMINE Your nutritional health	checklist questionnaire and BMI and mid arm circumference

Trial Locations

Locations (1): Thirumalai Poly Clinic and Raghavendra Diagnostic Centre
🇮🇳
Pondicherry, PONDICHERRY, India
Thirumalai Poly Clinic and Raghavendra Diagnostic Centre
🇮🇳Pondicherry, PONDICHERRY, India
Dr Sakthi Balan
Principal investigator
9443627722
saheerose@gmail.com