Shunthyadi Churna and Shwasa Kuthar Rasa for the Treatment of Bronchial Asthama.

Phase 1/2

Active, not recruiting

• Conditions: Bronchial Asthma

• Registration Number: CTRI/2016/06/007053
• Lead Sponsor: IPGT RA GAU Jamnagar

Brief Summary

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 Ayurvedictexts 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-28
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
relief in signs and symptoms of bronchial asthma	6 weeks

Secondary Outcome Measures

Name	Time	Method
relief in signs and symptoms of bronchial asthma	6 weeks

Trial Locations

Locations (1)

IPGT RA Hospital; 🇮🇳 Jamnagar, GUJARAT, India

IPGT RA Hospital

🇮🇳Jamnagar, GUJARAT, India

Rajnik K Jadav

Principal investigator

9429431744

rajnik720@gmail.com