A pilot, exploratory clinical study to evaluate the safety and efficacy of Respikshar-Y25 tablet in the patients with Asthma

The selected intervention for this study, Respikshar-Y25, comprises a polyherbomineral tablet formulation containing several key ingredients with purposeful therapeutic properties for management of Asthma. 

INDICATIONS AND USES

Mild to moderate patients of Asthma

STUDY OBJECTIVES

The proof-of-concept study presented here will be carried out with the following objectives:**A.**Primary objective:

1.     To observe changes in Peak expiratory flow rate (PEFR) value after treatment in Asthma patients compared with base line values.

 B. Secondary objective:

1.     To observe changes in respiratory rate, Absolute Eosinophil Count, Erythrocyte Sedimentation Rate (ESR), Asthma control questionnaire (ACQ) and Asthma control test (ACT) questionnaire after treatment in Asthma patients compared with base line values.

2.     To observe the safety of interventional drug.

STUDY DETAILSScreening visit (S1)

At the screening visits, (S1) Informed Consent will be taken and documentation of the same will be done. A detail interrogation for medical history, Concomitant Medication or any changes will be documented. Pregnancy Test (For Female subjects of child bearing potential) will be performed.  Physical Examinations, Vital Signs (Blood Pressure, Heart Rates, Temperature, Respiratory rate, SpO2), Peak expiratory flow rate (PEFR) will be measured, Blood collection will be done for the test Absolute eosinophil count and Erythrocyte Sedimentation Rate (ESR). Asthma control questionnaire (ACQ) and Asthma control test (ACT) questionnaire will be filled. Only for necessary participants LFT, KFT and chest X-ray will be performed. For eligible patients interventional drug, daily diary card and rescue medication will be provided.

Active treatment period

After the assessment, patients who fulfill all the eligibility criteria will enter in 4 weeks active treatment period. Study Medication, Daily diary Card and Rescue medication will be provided. Training for how to fill the diary will be given.

Follow up visits will be scheduled at 2nd and 4th week after inclusion. Patients will be called accordingly. A window period of ± 3 days will be allowed for each follow up visit.

 Visit T2:

In this visit**,**Vital Signs will be checked. Detail physical examination will be done. Peak expiratory flow rate (PEFR) will be measured. Asthma control questionnaire (ACQ) and Asthma control test (ACT) questionnaire will be filled. Blood collection will be done for the test Absolute eosinophil count and Erythrocyte Sedimentation Rate (ESR). Daily diary Card will be examined, Medication compliance, use of rescue medication, concomitant medication will be checked. Adverse events if any will be recorded. Study Medication till next follow up will be provided. Patients will be called for next visit after 2 weeks.

Visit T4:

In this visit**,**Vital Signs will be checked. Detail physical examination will be done. Peak expiratory flow rate (PEFR) will be measured. Asthma control questionnaire (ACQ) and Asthma control test (ACT) questionnaire will be filled. Daily diary Card will be examined, Medication compliance, use of rescue medication, concomitant medication will be checked. Adverse events if any will be recorded.

STUDY DURATONThe study duration will be total of 4 weeks after being recruited in the study. The whole study will be completed in 6 months period. ASSESSMENT OF STUDY

Following efficacy and safety parameters will be used for the assessment of the study. EFFICACY ASSESSMENT:·       Objective****assessment measures:

1.     Peak expiratory flow rate (PEFR)

2.     Respiratory rate

3.     Oxygen saturation (SpO2)

4.      Absolute eosinophil count

5.     Erythrocyte Sedimentation Rate (ESR)

6.     Chest X-ray (if necessary)

 Â·       Subjective assessment measures:

1.     Asthma control questionnaire (ACQ)

2.     Asthma control test (ACT) questionnaire

SAFETY ASSESSMENT:All the adverse events occurring throughout the treatment course will be recorded and managed accordingly. The safety of the patient will also be assessed by Changes in vital signs & clinically significant laboratory changes (if necessary) at the end of treatment period after administration on of treatment compared with baseline.STATISTICAL ANALYSISStudent’s paired ‘t’ test will be used, whereas non-parametric data will be evaluated using Wilcoxan matched paired test. P<0.05 will be considered as level of significance.