An open labelled RCT study to assess the efficacy of virechanottara shleshmakalanala rasa and ashwagandha ghana vati with agnimanthadi kashaya anupana in atopic triad on spirometric values and ige levels

NEED FOR THE STUDY

The atopic triad1 is presentation of three features in adults namely asthma, rhinitis and dermatitis.it is not having direct reference in ayurveda but such cases are reported in practice. Atopy is a genetic tendency to produce high IgE2 antibodies in response to common allergens, which increases the risk of developing atopic illnesses like atopic dermatitis3 asthma4, and allergic rhinitis5. it is anukta vyadhi and allergy is the common pathology for symptom triads but shwasa roga is pradhana out of the three, hence atopic triad is commonly treated by pulmonologists.   The incidence and prevalence of atopic diseases have risen in the last decade,  atopic dermatitis affecting 15-20% of children and 1-3% of adults asthma affects 2-10% of children  15 to 20% adults. . Allergic rhinitis has  a prevalence of 30% in those aged 17-29.1

The involvement of allergic inflammatory conditions and oxidative stress in the process of atopic triad is established. overactive immune response leads to inflammation and tissue damage, is further driven by T helper 2 cells producing cytokines like Interleukins (IL-4, IL- 5, and IL-13), release mediators such as histamine, leukotrienes, and prostaglandins- causing symptoms like itching, redness, swelling, and mucus production which is a vicious cycle, as the inflammation causes an increased allergen sensitization and further activation of the immune system.  inflammatory cascade  blocking actions of chemicals released by the allergic response in the epithelium by  Antihistamine, Anti inflammatory, antibiotic, bronchodilators, mucokinetic, mucolytics, analgesics, antipyretics are effective in managing atopic diseases.  Still cost effective remedy is expected by subjects so the need for research exists and it is the need of hour after covid 19, based on spirometry and IgE levels as evidences.

The research question is weather this anukta vyaddhi atopic triad can be treated by using the set of chikitsa sutra of shwasaroga with deepana pachana virechana and rasa rasayana  . Tulasi churna is deepana, pachana,rasayana,  shwasa kasa kushta peenasahara. 6.     Shleshmakalnala rasa is sodum based polyherbominerallometallic rasarasayana, kaphavataghna, jwarghna, swasa kasa hara, kshayahara, panduhara due to drugs like sudha parada, sudha gandhaka, vatsanabha, triphala, trikatu, trivrut, danti and pancha lavana7which has   indications for shwasa peenasa kushta based on the ingredients. so its effect in atopic triad can be researched.  Ashwagandha Ghana vati is potent rasayana, antioxidant, phytosteroid, anti inflammatory, immunomodulator, shwasahara, kshyahara, Balya.8 agnimanthadi kashaya (Agnimantha, Bala, Eranda, Kushta, Bharangi, Mahaushadha.) used as anupana is  having shwasa kasahara, kandughna kushtaghna and brumhana effect9

Hence with an alternate hypothesis, the present study entitled    - “AN OPEN LABELLED RCT STUDY TO ASSESS THE EFFICACY OF VIRECHANOTTARA ASWAGANDHA GHANA VATI AND SHLESHMAKALANALA RASA WITH AGNIMANTHADI KASHAYA ANUPANA IN ATOPIC TRIAD ON SPIROMETRIC VALUES AND IgE LEVELS’ is undertaken.

OBJECTIVES OF THE STUDY:

1.     To evaluate the combined effect of Virechanottara shleshmakalanala rasa , and ashwagandhaghana vati with agnimanthadi kashaya anupana and deepana ,pachana, rasayaneeya tulasi churna in atopic triad.

2.     To assess the effect of modern ongoing intervention in the management of atopic triad.

3.     To compare the effect of Virechanottara sleshmakalanala rasa, and ashwagandha ghana vati with agnimanthadi kashaya anupana with ongoing modern management of atopic triad.

SAMPLE DESIGN AND GROUPING

✓        STUDY TYPE -  prospective standard COMPARATIVE

✓        ESTIMATED ENROLLMENT -60

✓        INTERVENTIONAL MODEL - 2 GROUP ASSIGNMENT

✓       ALLOCATION-RANDOMIZED

✓        STUDY DURATION-   50 DAYS

✓        MASKING-OPEN

✓        FOLLOWUPAFTER-15DAYS

ASSESSMENT CRITERIA

SUBJECTIVE CRITERIA

ATOPIC TRIAD

1. SHWASA (ASTHAMA)

2. PRATISHYAYA  (RHINITIS)

3. VICHARCHIKA  (DERMATITIS)

1. SWASA  

SEVERITY

GRADE

|• No sign of dyspno

CS

|• Mild dyspnea after heavy work relieved by

rest

CD1

|• Mild Dysponea while walking

CD2

|• Moderate swasa even at rest

CD3

|•  Swasa need emergency intervention

CD4

  5. PRATISHYAYA

SEVERITY

GRADE

|• No discharge

CS

|• Occassional

CD1

|• Frequent

CD2

|• Continuous and heavy

CD3

|• Continuous and heavy with foul smell

CD4

  6. VICHARCHIKA  

SEVERITY

GRADE

|•   No itching

CS

|•   Ocassionally present relieves spontaneously

CD1

|•   Itching with rashes

CD2

|•   Itching with discharges

CD3

|•   Itching with discoloration

CD4

 OBJECTIVE CRITERIA

•        IGE,

•        AEC

•        SPIROMETRY

 E) OVERALL ASSESSMENT

•        VERY GOOD IMPROVEMENT        >75%

•        GOOD IMPROVEMENT                    51% TO 74%

•        MODERATE IMPROVEMENT-        26- 50%

•        NO RELIEF                                          <25