To Study the Effect of Yoga as an Add-On Therapy in the Management of Bronchial Asthma (Tamaka Shwasa)
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- The main sign and symptoms in the study are as follows
Study Overview
Brief Summary
The study design of an open-labeled randomized control clinical trial is planned for the research work. About 165 patients attend the OPD and IPD of Sir Sunderlal Hospital, IMS, BHU, Varanasi. The cases will be screened according to inclusion and exclusion criteria and those who will meet the criteria will be registered for the present study. The registered cases will be randomly allocated into 2 trial groups and 1 control group of equal sample size; each group has a sample size of 55. The Research Intervention will be given as per the protocols developed for this purpose. These interventions will be given to the experimental groups, the total duration of this study is 3 months and with 3 follow-ups at 30-day intervals.
Following are research groups.
Experiment Group (n=55) – Yoga Protocol with Ayurvedic Medicine.
Experiment Group (n=55) – Yoga Protocol with Modern Medicine, Step Therapy (standard dose) as Per GINA Guidelines.
Control Group (n=55) – Modern Medicine Step Therapy (standard dose) as per GINA Guidelines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age group between 20 to 60 years.
- •Signs and Symptoms of bronchial asthma Breathlessness, coughing, wheezing, and feeling of chest tightness.
- •Patients willing and able to participate in Yoga as mentioned above intervention and give informed consent.
Exclusion Criteria
- •Age below 20 years and above 60 years.
- •Patients who are suffering from thrombosis, stroke, and other severe abnormalities.
- •Patients who are suffering from other complicated respiratory diseases, swine flu, chronic obstructive pulmonary diseases, etc.
- •Patient with Hemodynamic inabilities.
- •A patient with dementia severe who fail to understand and follow instruction for Yoga.
- •Patient with Neuromuscular condition due to which unable to perform Yoga.
Outcomes
Primary Outcomes
The main sign and symptoms in the study are as follows
Time Frame: 90 days study with follow up of | every 30 days
1. Regular cough especially at morning or night.
Time Frame: 90 days study with follow up of | every 30 days
2. Allergies like sneezing, itching, blocked nose, running nose, congestion.
Time Frame: 90 days study with follow up of | every 30 days
3. Production cough, chest tightening.
Time Frame: 90 days study with follow up of | every 30 days
4. Excessive cough and mucus production.
Time Frame: 90 days study with follow up of | every 30 days
5. Breathlessness
Time Frame: 90 days study with follow up of | every 30 days
Secondary Outcomes
- Assessment of scoring of following scales(1. Spirometry)
Investigators
Chhaya Negi
Banaras Hindu University