An open labelled RCT study to assess the combined efficacy of virechanottara agnimukha churna over sapta balaadhanita maricha vati alone in the management of tamaka shwasa (bronchial asthma)

Bronchial asthma1 is a major disorder interrupting the lifestyle of an individual. Chronic recurrent airway diseases are increasingly seen all over the world due to atmospheric pollution, rapid environmental change, diet and lifestyle changes which has complex pathology, involving airway inflammation, intermittent obstruction, bronchial hyperresponsiveness, varying degrees of mononuclear cell and eosinophilic infiltration, mucus hyper secretion, desquamation of epithelium, along with smooth muscle hyperplasia, partially reversible due to airway remodeling. Anti-inflammatory, Antibiotic, Bronchodilation, Mucolytic and Anti-tussive medications are effective in the management of Bronchial asthma.

Tamaka shwasa mentioned in ayurvedic texts simulates with Bronchial asthma mentioned in western science, of Pranavaha srotas, predominantly Kapha vataja vyadhi originating from Pitta sthana, Kasta sadhya and Yapya vyadi. It is estimated with the of prevalence of 2.4 % adults in India2. Inspite of enormous development in modern science, a cost effective, Detoxification, Rejuvenation, Metabolic Improvement, Anti-inflammatory, Anti-viral, Immunomodulatory, Spirometry evidence-based regime is needed.

The research question is whether Kapha vatahara and pitta sthana pratyanika Virechana karma followed by oral admistration of Rasayana kalpa over Sapta balaadhanita Maricha vati alone is effective or not. In one group verticle research on Shodhana and Rasayana will be studied and compared with an Ekamoolika which will help in the general practice.

Virechana karma indicated in Tamaka shwasa3 which is Vata anulomaka, Kaphahara and removes mainly Kapha pitta doshas. Deepana pachana with Nayopayam kashaya4 as it does Amapachana and is Shwasa kasaharam param. Shodhananga Snehapana with Kantakari ghrita5 is kapha vatahara which acts as expectorant and clears the airways. Vishramakaleena abhyanga with Murchita tila taila6 helps to resolve Bronchospasm also. Virechana will be administered with Murchita eranda taila7 which is Vatanulomaka and Balya.

Agnimukha churna8 is polyherbal formulation having Hingu, Vacha, Pippali, Sringavera, Yavani, Haritaki, Chitraka, Kusta possesses properties like kapha vataghna, Kasa Shwasa nihanti ashu, Kshaya nashanam, Shula hara, Gulma hara.

Alone Sapta balaadhanita Maricha vati9,10 has kapha hara property, which acts as Mucolytic agent and helps to liquify the accumulated mucous in the airways. Piperine which is phytoconstituent of maricha helps to reduce Th2 cytokines (interleukin 4 and 5) and Histamine production. Its anupana are Ghrita, Kshoudra and Sharkara11. Maricha has Anti-bacterial, Anti-inflammatory, Anti-oxidant, Anti-cancer effect, Anti-obesity and Hepatoprotective properties.

Hence to know the efficacy of Shodhana and Rasayana in one arm and alone Ekamoolika prayoga is one of the extended branch of Kayachikitsa to promote Ayurveda contribution in general practice, hence the current title

‘‘AN OPEN LABELLED RCT STUDY TO ASSESS THE COMBINED EFFICACY OF VIRECHANOTTARA AGNIMUKHA CHURNA OVER SAPTA BALAADHANITA MARICHA VATI ALONE IN THE MANAGEMENT OF TAMAKA SHWASA (BRONCHIAL ASTHMA)’’ isundertaken**.**

OBJECTIVES OF THE STUDY :

To assess the efficacy of Virechanottara Agnimukha churna in Tamaka shwasa (Bronchial asthma)

To assess the efficacy of Sapta balaadhanita Maricha vati alone in Tamak shwasa (Bronchial asthma)

To compare the effect of Virechanottara Agnimukha churna over Sapta balaadhanita Maricha vati alone in Tamaka shwasa (Bronchial asthma)

STUDY DESIGN

Study type

Prospective, Add-on, Open labelled, Interventional RCT study

  |Estimated enrollment

40 subjects (20 in each group)

  |Intervention model

Comparative

INTERVENTION

Group A

Virechana followed by Agnimukha churna

|Group B

Sapta balaadhanita Maricha vati

|Masking

Open

|Primary purpose

Treatment

STUDY DURATION

Treatment duration

34 days

|Follow up

7 days

|Total duration

41 days

|Assessment on

Subjective -0th day, 13th day, 34th day and 41st day

Objective -Before and after intervention

OUTCOME MEASURES

Primary

Improvement in sign and symptoms of Tamaka Shwasa

|Secondary

Improvement in Objective

DIAGNOSTICCRITERIASUBJECTIVE PARAMETERS

Signs and symptoms of Tamaka Shwasa - Shwasa krichrata, Kasa, Kapha nishtivana, Ghur ghuraka.

INCLUSION CRITERIA· Subjects with classical symptoms of Tamaka shwasa (Bronchial asthma).

· Subjects age between 20 to70 years.

· Subjects fit for Virechana.

· Subjects irrespective of Religion, gender, socio economic status, occupation.

· Subjects who signed for informed consent form.

EXCLUSION****CRITERIA· Pregnant and lactating women.

· Subjects suffering from chronic systemic complex diseases which interferes with the course of intervention will be excluded.

 GRADING FOR SUBJECTIVE PARAMETER**:**1. SHWASA KRICHRATA

2. KASA

3. KAPHA NISHTIVANAM

4. GHUR GHURAKA

1. Shwasa krichrata**(Breathlessness)**

 

SEVERITY

GRADE

|No symptoms

CD0

|Breathless with activity, frequency-1 to 2times/week.

CD1

|Breathless with talking, frequency 2 to 4 times/week

CD2

|Breathless at rest, frequency 4 to 6 times/week, with limited activity.

CD3

2. Kasa**(Cough)**

SEVERITY

GRADE

|No cough

CD0

|Cough with mild pain

and slight expectoration.

CD1

|Cough with severe pain & feelings of Restlessness because of difficulty in

expectoration.

CD2

|Frequent coughing due to which patient becomes

faint.

CD3

 3. Kapha****Nishtivanam (expectoration)

 

SEVERITY

GRADE

|No kapha nistivanam.

CD0

|Kapha nistivanam only in the early morning.

CD1

|2-3 times Kapha nistivanam /day

CD2

|kapha nistivanam always

CD3

 4. Ghur ghuraka**(Wheezing**)

 

SEVERITY

GRADE

|No wheezing

CD0

|Mild wheezing at mid to end respiration

CD1

|Moderate wheezing at mid to end respiration

CD2

|Loud wheeze throughout expiration

CD3

|Loud inspiration and expiration wheeze

CD4

OBJECTIVE****CRITERIA• SPIROMETRY

• AEC

• IgE

EOSINOPHIL %

OVERALL****ASSESSMENT· VERY GOOD IMPROVEMENT    -  >75%

· GOOD IMPROVEMENT                -  51% TO 74%

· MODERATE IMPROVEMENT     -  26-50%

· MILD IMPROVEMENT                 -  <25%

· NO IMPROVEMENT                     -  0