CLINICAL EVALUATION OF SIMHYADI KWATH ALONG WITH SHATI CHURNA IN THE MANAGEMENT OF TAMAKA SHWAS W.R.T. BRONCHIAL ASTHMA-RANDOMIZED CONTROL STUDY

Tamaka Shwas is one among the diseases of Pranavaha srotas. According to Acharya Charaka roots of pranavaha srotas are Hridaya and Mahasrotas but Acharya Sushruta mentioned Rasavahini Dhamani in place of Mahasrotas and alongwith Hridaya. As per Ayurveda principles, Shwas Roga is Kapha-Vataja Vyadhi originated from Pitta Sthana. The Kapha dosha obstructs the movement of Prana vayu, as a result vitiated vayu goes in adverse directions (pratilomagati) resulting in Tamaka Shwas.

Tamaka Shwas described in Ayurveda can be correlated with Bronchial Asthama based on clinical manifestation. Tamaka Shwas is an important disease because of worldwide /prevalence. In acute stage this disease can produce serious condition such as acute severe asthma whereas in chronic condition this disease results with several implications such as corpulmonale.

Bronchial asthma is characterized by chronic inflammation of airway and increased airway responsiveness resulting in symptoms such as wheeze, cough, chest tightness and dyspnoea. It is also functionally characterized by the air flow limitations which usually reverse spontaneously or with treatment.

Shwas is considered as the most serious disease in Ayurveda and stated that none other disease kills a person as instantaneously as Shwasa.

Acharya Charaka has prescribed 500 kashayas in 50 Maha kashayas which are described with their characteristics e.g.-the Maha kashayas which contains jeevaka, jeevanti etc. is termed as jeevaniya Dashemani. Similarly lekhniya, Shvashhar Dashemani are there in the list of Dashemani. Individual drugs of each Dashemani makes a separate kashaya. Again these 50 Dashemani having classified in 10 groups. The sub classification has been done on the basis of name of Dashemani. Some group are classified on the basis of its action i.e Dashemani useful for panchakarma are grouped into subtypes like Snehopaga, Swedopaga,Vamanopaga etc. Shwasahara Dashemani has 10 drugs which are used to treat underlying pathology involved in the disease Pranavaha Srotas e.g Tamaka Swasa. The Shwasahara Dashemani contains 10 drugs such as – Shati, Puskarmoola, Amalavetas, Ela, Hingu, Agaru, Surasa, Tamalaki, Jeevanti and Chandana.

TRIAL DRUGS REVIEW:

 Indigenous compound formulation used for the trial is SIMHYADI KWATH (Yoga Ratnakar) along with SHATI CHURNA (Acharya Charaka).

 1.      SIMHYADI KWATH: This indigenous compound drug formulation is described by Yoga ratnakar for the treatment of Shwas.

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कृषà¥à¤£à¤¾à¤®à¤°à¥€à¤šà¥‡à¤®à¤¿à¤²à¤¿à¤¤à¤¾***:*** कषाय: ***शà¥à¤µà¤¾à¤¸à¤¾à¤Ÿà¤µà¥€***दाहपयोदà¤à¤·: ||4||   (Yog ratnakar purvardh)

2. SHATI CHURNA**:** The description of this drug is available in Charaka Samhita as first drug in Shvashhar Dashemani.

AIMS AND OBJECTIVES:

The aims and objectives behind conducting this study are:

Primary Objectives:

·         To evaluate the clinical efficacy Simhyadi Kwath along with Shati churna in the management of Tamaka Shwas.

·         To study the etiopathogenesis of Tamaka Shwas from Ayurveda and Modern point of view.

Secondary Objectives:

·         To evaluate the effectivity & safety of Simhyadi Kwath along with Shati churna in the management of Tamaka Shwas.

·         To compare the clinical effect of trial drug (Deriphyllin) in the management of Tamaka Shwas (Bronchial Asthma).

·         To develop a safe and effective drug that can be helpful for the Asthmatic community to combat the ailment

MATERIALS AND METHODS**:**

The study design is as follows:

Study type:                                                Interventional

Sub-type   :                                                Control trial

Purpose   :                                                 Treatment

Timing    :                                                  Prospective

Masking:                                                   Open trial

Sampling Method:                                   Simple Random

End Point   :                                              Efficacy and Safety

Sample Size:                                             60 patients (30 in each group)

Number of groups:                                  2 groups {A & B}

Group A: Simhyadi Kwath along with

Shati Churna

Group B: Deriphyllin

Selection of Cases:                                   O.P.D. /I.P.D.

Sample population:                                 Patients from college hospital

Duration of the Trial:                             3 Months

Inclusion criteria:

Patients having classical features of Tamaka Shwas (Bronchial Asthma) as Shwaskashtata (Breathlessness), kasa (cough), kaphasthivanam (expectoration), ghurghurkama (audible wheeze), asinolabhatesaukhyam , sleshma vimokshante labhate saukhyam (feeling of wellness after expectoration of cough), peenas (running nose), parshvagraha (pain in chest region) irrespective of Sex & Religion.

1.      Age- 18 to 60 years.

2.      Chronicity- less than 10 years.

3.      Patients with stable condition.

4.      Severity as mild to moderate stable bronchial asthma **(**Tamaka Shwas) as per W.H.O GINA Guidelines

5.      Patient on other drug therapy will be included only after completion of the washout period of 3 weeks

Exclusion Criteria:  Patients suffering with above disorders would be excluded :

1.      Age - <18 years, >60 years

2.      Patients suffering from

a.       Pulmonary tuberculosis

b.      Lung Cancer, Lung fibrosis

c.       Emphysema, Bronchiectasis

d.      Cor- Pulmonale, IHD, Hypertension will be excluded.

e.       Status asthematicus.

3. Type – 2 Diabetes with uncontrolled blood sugar levels.

4. Patients on Corticosteroids

5. Chronicity>10yrs

6. Pregnancy

DRUG DELIVERY REGIMEN

Group A

Group B

|DRUG

Simhyadi Kwath

Shati Churna

Deriphyllin

|FORM

Decoction

Powder

Tablet

|DOSE

20 ml QID

2.5 gm. QID

150 mg BD

|MODE OF ADMINISTRATION

Oral

Oral

Oral

|ANUPAN**/**SAHPAN

Pippali and Marich Powder

Warm Water

Plain Water

|DURATION

3 months

3 months

3 months

 ASSESSMENT CRITERIA:

PRIMARY END POINT- •       Improvement in classical sign and symptoms of Tamaka Shwas

•       Decrease in frequency, duration and severity of attacks.

 SECONDARY END POINT-  •       Pulmonary function tests by spirometry and peak expiratory flow (PEF) meter