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Treatment of difficulty in breathing with Unani medicine Habb-e-Sadr

Phase 3
Conditions
Health Condition 1: J459- Other and unspecified asthma
Registration Number
CTRI/2024/06/069434
Lead Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Males and females of 18-65 years.

2. Patients of Bronchial Asthma for at least 3 months presenting with at least one of the following symptoms:

Wheeze

Shortness of breath

Chest tightness and cough that vary over time

and in intensity,

Expiratory airflow limitation as suggested by a

decreased FEV1

3. Objective evidence for reversible airway obstruction (=12% and =200 mL change in FEV1 and/or a 25% and 60 L/min change in PEFR) either spontaneously or after treatment.

4. Patients with Asthma Control Questionnaire Score more than 1.5

Exclusion Criteria

1. FEV1/FVC ratio less than 50%.

2. Pregnant and lactating mother

3. Patient with other Respiratory Tract Infections, tuberculosis and malignancy.

4. Patient of Presence of chronic cough with expectoration for 2-3 months in each of 2 successive years.

5. Patient with co-morbidities, Diabetes Mellitus, Hepatic and Renal Insufficiency.

6. Patients with Tobacco Smoking.

7. Patient with regular use of oral or systemic corticosteroids for conditions other than Asthma.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The efficacy of the study drug in the treatment of mild to moderate Zeeq un Nafas (Bronchial Asthma) will be assessed on the basis of Absolute Eosinophil Count (AEC), IgE, Spirometory test, FeNO test and improvement in the Asthma Control Questionnaire (ACQ).Timepoint: At baseline and 2, 4, 6 weeks
Secondary Outcome Measures
NameTimeMethod
Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.Timepoint: At baseline and 6 weeks
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