A Comparative Study to Evaluate the Efficacy of Shwasahara Mahakashaya Avleha w.r.to Shwasahara Mahakashaya choorna in Tamaka Shwasa w.s.r to Childhood Bronchial Asthma–An open ended, double armed, Randomized, Controlled Clinical Trial.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1. Improvement in classical sign and symptoms of Tamaka Shwasa.
Study Overview
Brief Summary
.
On the basis of their clinical manifestation. Tamaka Shwasa is as described in Ayurveda can be correlated with the disease bronchial asthma of modern medical science [1].
Bronchial asthma is characterized by chronic airway inflammation and increased airway.Bronchial asthma is characterized by chronic airway inflammation and increased airway responsiveness resulting in symptoms of wheeze, cough, chest tightness and dyspnoea. It is also functionally characterized by the air flow limitations which usually reverse spontaneously or with treatments.
The prevalence of bronchial asthma has increased continuously since the 1970 and now effects 4-7% of the people worldwide[2].There has been increase in the prevalence, and a similar trend is observed in India. Asthma prevalence rate in some states of India like Karnataka, Gujarat, Hariyana, Uttar Pradesh, Madhya Pradesh are above the national level[3]. The disease is more predominant in children and aged population. At the age of 6-7 years the prevalence ranges from 4%-32% apart from being the leading cause of hospitalization for children, it is one of the most important chronic condition causing elementary school absenteeism[4,5].
There is limited information on the various modalities of Ayurvedic management on Tamaka Shwasa i.e. Bronchial Asthma especially in children. The treatment principles of Tamaka Shwasa as described in our classical texts includes Shodhana, Shamana, herbal and herbominerals compound. In Charaka Samhita, It contributes several modalities of the treatment for Shwasa roga (asthma). Among all modalities of treatment, polyherbal combinations are said to be well-accepted, safe and effective in asthma. Maharsi Charaka described 10 drugs in Shwasahara Mahakashaya in sutra Sthana [6].
Acharya Charaka has summarized 500 kashayas in 50 Maha kashayas. The Maha kashayas are described with their characteristics. For example-the Maha kashayas which contains jeevaka, jeevanti etc. is termed as jeevaniya mahakashaya. Again these 50 Mahakashaya having classified in 10 groups. The sub classification has been done according to the similarities of name of Mahakashaya. Some group are classified on the basis of its action i.e Mahakashaya useful for panchakarma are grouped into subtypes like Snehopaga, Swedopaga,Vamanopaga etc. Among these, Shwasahara Mahakashaya also contains 10 drugs and is used to treat the condition of Pranavaha Srotas like Tamaka Swasa. The Shwasahara Mahakashaya contains 10 drugs such as – *Shati, Puskarmoola, Amalavetas, Ela, Hingu, Agaru, Surasa, Tamalaki, Jeevanti and Chanda.*OBJECTIVES OF THE RESEARCH PROJECT:
The present research trial has been undertaken with the following objectives.
PRIMARY OBJECTIVES:
ï‚· To assess the efficacy of Shwasahara Mahakashaya in childhood bronchial asthma
SECONDARY OBJECTIVE: - ï‚· To assess the improvement in quality of life of children and parents.
METHODOLOGY:
Patients will be randomly selected from OPD of age group 5-15 years. The children coming under the inclusion criteria of the study and their parents will be counselled and informed about the treatment plan. Those who are willing to undergo the therapy and ready to submit informed consent shall be recruited in the proposed clinical study. The selected subjects will be randomly divided into two groups with the help of computer generated randomization table.
CLINICAL STUDY:
| Study type |
Interventional, Comparative, Superiority
|Purpose
Treatment
|Timing
Prospective
|End Point
Efficacy
|No. Of groups
Two groups
|Sample size
60(30 in each group)
SETTING - Clinical study will be conducted in the department of Kaumarabhritya, All India Institute of Ayurveda, New Delhi.
SIZE AND SAMPLE CALCULATION- As per the study of Neha R. Patel et.al [9], the proven efficacy of Shwasahara Mahakashaya choorna is 54% and 70% is expected in present study with the level of significance in 95% and power of 80%.the sample size is calculated on this base by using the following formula. Formula for 2 groups
n =2 (Zα+Zβ)2/ (p0-p1)2 x pq
Average sample size will be 144.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 5.00 Year(s) to 15.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Individuals of either gender between age group of 5 to 15 years.
- •Diagnosed cases of Tamaka Shwasa –bronchial asthma with at least 3 episodes of asthma symptoms (cough, breathlessness) during the previous year.
- •Severity as mild to moderate stable bronchial asthma (Tamaka Shwasa) as per W.H.O GINA Guidelines.
- •Patient on other drug therapy will be included only after completion of the washout period of 3 weeks.
- •Parents giving consent to participate in study.
Exclusion Criteria
- •1.Individuals below 5 years and above 15 years of age.
- •2.Sever case like status asthmaticus.
- •3.Evidence of active concomitants pulmonary disease other than asthma.
- •4.Evidence of requirement of intubation for asthma, or had been hospitalized for asthma within 1 month before.
- •Had unresolved sinus disease or an unresolved upper or lower respiratory tract infection within 3 weeks.
- •5.More than 4 short courses of oral corticosteroids within the year preceding the screening visit or any oral corticosteroids in the preceding 4 weeks.
- •6.Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, haematological, neurological, immunological).
- •7.Patient/Parents not willing to participate in the study.
Outcomes
Primary Outcomes
1. Improvement in classical sign and symptoms of Tamaka Shwasa.
Time Frame: 0 day,15th day,30th day,45th day60th day
2.Decrease in frequency, duration and severity of attacks.
Time Frame: 0 day,15th day,30th day,45th day60th day
Secondary Outcomes
- 1-Asthma control questionaire(2-GINA asthma guidelines)