A clinical trial to understand the safety and efficacy of an herbal anti-asthmatic medicine prepared from the plant Desmodium adscendens.

Phase 3

• Conditions: Respiratory

• Registration Number: PACTR202209743149100
• Lead Sponsor: Ronald Yeboah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Male and female patients within the age range of 15 - 45 years with severe, moderate or mild asthma defined as an Asthma Score Questionnaire (ASQ) score of 30-20: Severe asthma, 19-10: Moderate asthma, 10-0: Mild asthma.
2.Patients diagnosed with asthma defined as subjects with medical and physical evidence of recurrent episodes of reversible airflow obstruction for at least six (6) months. These signs and symptoms of airway hyper responsiveness include wheezing, cough, chest tightness and shortness of breath (often worse at night).
3.A forced expiratory volume (FEV1) in 1 second of 50% to 90 % of predicted or a 12% increase in the baseline of FEV1 after the administration of a ß-agonist.
4.Ability to comply with protocol and complete written informed consent process to participate in the trial.

Exclusion Criteria

1.Patients with Chronic Obstructive Pulmonary Disease (COPD). E.g., emphysema and bronchitis.
2.Patients with current and/or recurrent chest infections after a radiograph.
3.Patients who have been diagnosed as status asthmaticus.
4.Patients who are on steroidal drugs and theophylline within the past month.
5.Pregnant and lactating mothers.
6.Patients with chronic liver or kidney disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary measure of efficacy of the treatment will be the resolution of all signs and symptoms of airway hyper responsiveness; example, wheezing, cough, chest tightness, and shortness of breath, an Asthma Score Questionnaire (ASQ) of 0 and increase in FEV1 to 95% and above of the predicted FEV1. Time-to-first use of rescue medications post treatment.

Secondary Outcome Measures

Name	Time	Method
Time-to-first emergency intervention at a health facility.<br>Frequency of rescue use of short acting ß-2 agonists.<br>Improvement in the Quality of Life (QOL) of volunteers.<br>The absence of an any untoward effects on the bodily organs as well as side effects (safety evaluation) will be considered as a secondary outcome.