RESEARCH QUESTION- Is there any effect of Kunjal Kriya compared to breathing exercises on lung capacity of healthy individuals?

HYPOTHESIS:

Null Hypothesis (H⁰)

Practicing Kunjal kriya on Healthy individuals for 90 days does not show any additional effect on lung capacity.

Alternate Hypothesis (H¹)

Practicing Kunjal kriya on Healthy individuals for 90 days show effect on lung capacity.

INTRODUCTION:

The lungs are the foundational organs of the respiratory system, whose most basic function is to facilitate gas exchange from the environment into the bloodstream. Oxygen gets transported through the alveoli into the capillary network, where it can enter the arterial system, ultimately to perfuse tissue. The respiratory system is composed primarily of the nose, oropharynx, larynx, trachea, bronchi, bronchioles and lungs. The lungs further divide into individual lobes, which ultimately subdivide into over 300 million alveoli. The alveoli are the primary location for gas exchange. The diaphragm is the primary respiratory muscle and receives innervations by the nerve roots of C3, C4, and C5 via the phrenic nerve.  The external intercostals are inspiratory muscles used primarily during exercise and respiratory distress.

NEED OF THE PRESENT STUDY

1. Lung capacity predicts health and longevity. Our lung capacity naturally declines with age, starting at age 30. By the age of 50, our lung capacity may be reduced by as much as 50%.
2. Burning problem of metro cities is air pollution, which is a factor reducing lung capacity. It may deteriorate lungs capacity in healthy volunteers also.
3. During second wave of COVID 19 disease, there was gargantuan rise in demand of oxygen. It mainly affects on upper & lower respiratory tract and most of the casualties are due to pulmonary dysfunction.
4. Person having active lifestyle, need more oxygen demand in daily routine. If they have more lung capacity, oxygen is more sufficiently sent to muscles that means we are able to train longer and with a lower sense of effort.
5.  Nowadays Healthy people are also in need to improve their lung capacity as preventive measure to sustain healthy life.

OBJECTIVE

1.     To evaluate the effect of Kunjal kriya in lung capacity of healthy individuals.

OUTCOME OF STUDY

1.     After practicing Kunjal kriya once in a week for 3 months may increase lung capacity as compared to breathing exercises. (Ragavendrasamy B.-2017)

METHODOLOGY

CCLINICAL STUDY:

v Study Design: Randomized Controlled Clinical Trial

v Study Type: Interventional Study

v Allocation: Randomized

v Interventional Model: Parallel Assignment

v Masking: Open Label

v Groups: Two

 1.     Study Setting: Healthy Volunteers will be recruited from All India Institute of Ayurveda and Ayurvedic & Unani Tibbia College & Hospital, New Delhi.(after getting approval of MoU between AIIA & AUTC)

2.     Sample Size Calculation:

In the previous study, FVC was increased by mean = 0.23 by Yogic breathing. Since Kunjal kriya is more effective than Yogic Breathing Practices, we expect an increase in FVC by mean = 0.50

Pooled standard deviation would be 0.62, Type I error = 95% and power of the study as 80% and 20 % drop out.

Sample size = 2(SD) ²(1.96 + 0.84)²/d²

                    = 2(0.62)² (1.96+0.84)² / (0.5-0.23)²

                                = 2(0.38) (7.84) / 0.0729

                                = 82.68

The calculated sample size is 100 in each group.

 3.     Inclusion criteria-

                               i.     Age : 18 to 40 years

                             ii.     Gender: Either sex male or female

                           iii.     Healthy volunteers irrespective of sex, caste and religion etc. willing to give informed consent to participate in the study.

4.     Exclusion criteria-

                               i.     Volunteers having acute respiratory disease and chronic respiratory disease.

                             ii.     Any other additional disease (Hypertension, Diabetes Mellitus, Asthma, Chronic Renal Failure, Peptic Ulcer, Hernia, Lung Abscess, Tuberculosis, Malignancy, etc.)

                           iii.     Pregnant& Lactating Mother

                            iv.     Volunteers who are currently participating or have completed participation in any other clinical trial during the past six months.

5.     Special Condition for Kunjal kriya practice-

                            i.        Kunjal will not be scheduled in menstruating women who is expecting menstruation or already menstruating for 3-4 days. Next visit will be planned after completing these 3-4 days.

6.     Groups:

a.      Group A - In this group, 100 healthy volunteers will be enrolled and advised to do Kunjal kriya at early morning with empty stomach once in week for90days (12 sittings.)

b.     Group B - In this group, 100 healthy volunteers will be enrolled and advised to do Yogic Breathing Practices early morning empty stomach for half an hour, five days a week for 30 days.

7.     Intervention

          Standard Operating Procedure Of Kunjal Kriya(Group A) 

               Practice of Kunjal kriya- ¹⁵

                                                              i.     Water for Kunjal:  Luke warm Water

                                                            ii.     Quantity of Water for Kunjal:  1-2 litre or as one can take maximum

                                                          iii.     Salt addition: 2 TSF in 2 litre

9.     Withdrawal criteria-

The participant may withdraw from the trial if

                                   i.     Volunteers develops any serious condition or adverse effect

                                 ii.     A volunteer wants to self withdrawal from the research

10.  Instrument/ Equipment Required: The instrument which is used to measure or count above mentioned parameters is Spirometer and the method is known as Spirometry. It is a very common test to see how well your lungs work. Spirometry measures three major things:¹⁶

1.     How much air one can breathe in (Inhale)

2.     How much air one can breathe out (Exhale)

3.     How fast one can exhale the air from lungs

11.  Rescue Medicine:

If there is any occasion of emergency, then use of rescue medication will be

                   permitted as per the need of the patient.

12.  Assessment of adverse events:

All subjects are to be questioned regarding adverse events during treatment at       each visit. Any adverse events will be reported to pharmacovigilance center, AIIA, Sarita Vihaar, New Delhi.

13.  Assessment criteria:

Assessment will be done on the basis of the following parameters at the baseline and at the end of study using Spirometer.

 14.  Time Of Assessment:-

1)     Baseline

2)     After 90 ( Group A) & 30 days & 90 Days (Group B)

15.  Statistical Methods For Analysis:

The information that will be gathered & will be subjected to statistical analysis in terms of mean, standard deviation and standard error etc.

For parametric data comparing two groups Z test will be applied in excel 2019.

      For Non- parametric data comparing two groups Mann-Whitney tests.