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TO OBSERVE THE EFFECT OF AYURVEDIC MEDICINE FOR THE TREATMENT OF BRONCHIAL ASTHMA (TAMAK SHWASA)

Phase 2
Conditions
Health Condition 1: null- Mild Stable Bronchial Asthma (Tamak Shwasa)
Registration Number
CTRI/2018/06/014425
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

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

1. Patients of either sex with age between 18 to 60 years.

2. Diagnosed cases of the mild predominant or persistent stable Bronchial Asthma (Tamaka

Shwasa) (as per GINA Guideline)

3. FEV1 >80% of the predicted value

4. Patients willing to participate and written consent

Exclusion Criteria

1. Patients with FEV1 < 80% of the predicted value.

2. Patients with Diabetes Mellitus, Chronic Obstructive Pulmonary Disorder (COPD),

Cardio vascular diseases, malignancy etc.

3. Patients with unstable Cardiovascular disease

4. Patients suffering from other major systemic illness which may influence the study as per

the PI.

5. Patients with LFT, Aspartate Amino Transferase (AST) and / or Alanine Amino

Transferase (ALT) > 2 times upper normal limit or Serum Creatinine more than the upper

limit of normal value.

6. Pregnancy or lactating women.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Change in Asthma Control Questionnaire (ACQ) <br/ ><br>2. Frequency of need for control medicationTimepoint: On baseline, 14th day, 28th day, 42th day, 56th day, 70th day, 84th day and 98th day
Secondary Outcome Measures
NameTimeMethod
1. Any improvement in FEV1 <br/ ><br>2. Changes in serum CRP, IgE <br/ ><br>3. Frequency of need for rescue medication <br/ ><br>4. Any Adverse EventsTimepoint: On baseline, 14th day, 28th day, 42th day, 56th day, 70th day, 84th day and 98th day
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