Use of Roselle in Bronchial asthma and Malnutrition

Clinical study to evaluate the Efficacy and safety of ROSELLE in patients with Bronchial asthma and Malnutrition.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027013

Enrollment

Registered

2020-08-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J454- Moderate persistent asthma

Interventions

Intervention1: Roselle liquid syrup: Ingredients: Roselle juice, Suga, water, Antioxidants (Ascorbic acid). 30 ml mixed in 8 parts of water and taken orally after food once daily Control Intervention1

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 analysing average daily symptom scores 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.Timepoint: week 4, 8 and 12	—

Measure

Time frame

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 analysing average daily symptom scores 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.Timepoint: week 4, 8 and 12

—

Secondary

Measure	Time frame
Evaluation of nutritional status using DETERMINE Your nutritional health checklist questionnaire and BMI and mid arm circumferenceTimepoint: week 4, 8 and 12	—

Countries

India

Contacts

Public ContactDr M Sakthi Balan

KI3, CRO

saheerose@gmail.com9443627722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026