This study is open label clinical study to evaluate the effect of shunthyadi churna and shwaskuthar rasa on tamaka shwasa
Routine blood investigation will be performed to rule out other
systematic pathology.
Special scoring scale has been prepared based on information in
Ayurvedic classical texts which will be utilized for assessment and evaluation

PLAN OF STUDY :

            The study work will be divided into following parts.

1.      Conceptual Study :

            Detailed study of etiopathogenesis from textual references as well as views opinioned by commentators along with modern texts, journals, research papers, etc will be done and recorded on bronchial asthma.

2.      Pharmacognostical and Pharmaceutical Study :

Shunthyadi Churna will prepared from its contains as given below. The classical formulation of the Shunthyadi Churna is mentioned in classical text of Yogratnakar in Shwas Chikitsa Prakranam in the form of Churna.

3.      Clinical Study :

Patients study will be carried out under the department of Kayachikitsa

Ø  The patients will be selected from the O.P.D. and I.P.D. of I.P.G.T. & R.A. HOSPITAL, Jamnagar for the study.

Ø  Primarily the patient will be selected on the basis of the presence of classical symptomatology of Tamaka Shwasa. Patient will be subjected to the detail history and physical examination on the basis of specially prepared research proforma.

Diagnostical Criteria :

            Presence of signs and symptoms like intermittent reversible attacks of dyspnoea, wheezing, chest tightness, fatigue, anxiety, coughing and examinations mentioned in Ayurvedic texts and modern medical sciences.

Inclusion Criteria

·         Patients having signs and symptoms of Tamaka Shwasa described in Ayurvedic texts and modern texts will be included.

·         Age group : 16 – 60 years

·         Chronicity less than 10 years

·         Uncomplicated cases of Tamaka Shwasa

Exclusion Criteria :

·         Patients of age less than 16 and above 60 years.

·         The patient suffering from tuberculosis, Cardiac complains etc

·         Endocrine disorders like diabetes mellitus, Hypo or Hyperthyroidism, etc

·         Patients having complications like cor-pulmonale, emphysema, pneumonia, malignancy, etc and breathlessness due to severe anaemia, renal failure, etc

Investigations :

·         Laboratory investigations : Hb, CBC with absolute Eosinophil count.

·         P.E.F.R. test

·         Spirometry

·         Radiological examinations

·         Sputum test will be done if necessary.

·         ECG will be performed for differential diagnosis with any other disease.

·         Any other necessary investigation as and when necessary

FRAME OF WORK

Study design :

      Study Type                                                     : Interventional

      Purpose                                                           : Treatment

      Masking                                                          : Open label

      Control                                                            : Randomised controlled

      Timing                                                             : Prospective

      End Point                                                        : Efficacy and Safety

      No. of Groups                                                             : 2 groups

      Subjects                                                           : approximately 20 subjects in each                                                                                    group

Method of Research : Open clinical trial

Grouping : A) Shunthyadi churna 3 gms tds with honey after meal

                  B) Shwaskuthar rasa  250 mg tds with honey after meal

PATHYAPATHYA :

Proper diet and Pathyapathya will be advised to all the patient with specific cold intake. It will be advised as per classics in both the groups[1].

      Pathya: Godhuma, Yava, Kulattha, Old Shathi and Red Shali rice, Patola, Rasona, Bimbi, Chori, Tanduliyaka, Mulaka, Jivanti, Draksha, Amalaka, Pakva Kapittha, Nimbu, Sura, Madira, Ushnodaka, Purana Sarpi, Aja Ghrita, Aja Paya, Madhu,  Snehana-Svedana, Dhumapana, Divasvapa.

      Apathya: Masha, Shakkarkanda, Palandu, Surana, Sarshapa, Banana, Shitodaka, Avi Dugdha, Avi Ghrita, cold milk, curd preparations, ice creams, Vegavarodha, Raja, Pragvata, Atapa.

Withdrawal Criteria

·         Subjects develop any serious adverse effect (necessitating hospitalization)

·          if there is no response of the drug on the patient of Tamaka Shwasa (Bronchial Asthma)

CRITERIA OF ASSESSMENT:

The patients will be examined weekly. Changes in patient’s condition will be noted & following points will be taken into consideration for the assessment of the results.

1.      Clinical features of Tamaka Shwasa will be assessed during weekly till the end of treatment.

2.      Hb%, CBC with Absolute eosinophilic count will be carried out before & after treatment.         

3.      PEFR will be repeated during treatment.Spirometry will be carried out before and after treatment

Subjective Criteria :

 Classical symptomatology of the disease Tamaka Shwasa and cardinal symptoms of Bronchial Asthma will be taken as subjective criteria.

Objective Criteria :

•      Laboratory investigations : Hb, CBC with absolute Eosinophil count.

•      P.E.F.R. test

•      Spirometry

•      Radiological examinations.