Effect of Kunjal Kriya and Yogic Breathing Practices in assessing Lung Capacity in Healthy Volunteers – A Randomized Controlled Trial

RESEARCH QUESTION- Isthere any effect of Kunjal Kriya compared to breathing exercises on lungcapacity of healthy individuals?

HYPOTHESIS:

Null Hypothesis (H0)

PracticingKunjal kriya on Healthy individuals for 90 days does not show any additionaleffect on lung capacity.

Alternate Hypothesis (H1)

PracticingKunjal kriya on Healthy individuals for 90 days show effect on lungcapacity.

INTRODUCTION:

The lungs are thefoundational organs of the respiratory system, whose most basic function is tofacilitate gas exchange from the environment into the bloodstream. Oxygen getstransported through the alveoli into the capillary network, where it can enterthe arterial system, ultimately to perfuse tissue. The respiratory system iscomposed primarily of the nose, oropharynx, larynx, trachea, bronchi,bronchioles and lungs. The lungs further divide into individual lobes, whichultimately subdivide into over 300 million alveoli. The alveoli are the primarylocation for gas exchange. The diaphragm is the primary respiratory muscle andreceives innervations by the nerve roots of C3, C4, and C5 via the phrenicnerve.  The external intercostals are inspiratorymuscles used primarily during exercise and respiratory distress.

NEEDOF 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.     Toevaluate the effect of Kunjal kriya in lung capacity of healthy individuals.

 OUTCOME OF STUDY

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

METHODOLOGY

CCLINICAL STUDY:

vStudyDesign: RandomizedControlled 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 willbe recruited from All India Institute of Ayurveda and Ayurvedic & Unani TibbiaCollege & Hospital, New Delhi.(after getting approval of MoU between AIIA& AUTC)

2. Sample Size Calculation:

In the previous study, FVC wasincreased by mean = 0.23 by Yogic breathing. Since Kunjal kriya is moreeffective than Yogic Breathing Practices, we expect an increase in FVCby mean = 0.50

Pooled standard deviation would be0.62, Type I error = 95% and power of the study as 80% and 20 % drop out.

Samplesize = 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

Thecalculated sample size is 100 in each group.

3. Inclusioncriteria-

i.     Age: 18 to 40 years

ii.     Gender:Either sex male or female

iii.     Healthyvolunteers irrespective of sex, caste and religion etc. willing to giveinformed consent to participate in the study.

4. Exclusioncriteria-

i.     Volunteershaving acute respiratory disease and chronic respiratory disease.

ii.     Anyother additional disease (Hypertension, Diabetes Mellitus, Asthma, ChronicRenal Failure, Peptic Ulcer, Hernia, Lung Abscess, Tuberculosis, Malignancy,etc.)

iii.     Pregnant&Lactating Mother

iv.     Volunteerswho are currently participating or have completed participation in any otherclinical trial during the past six months.

5. SpecialCondition for Kunjal kriya practice-

i.       Kunjal willnot be scheduled in menstruating women who is expecting menstruation or alreadymenstruating for 3-4 days. Next visit will be planned after completing these3-4 days.

6. Groups:

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

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

7. Intervention

Standard Operating Procedure Of Kunjal Kriya(Group A)

Practice of Kunjal kriya- 15

i.     Waterfor Kunjal:  Luke warm Water

ii.     Quantityof Water for Kunjal:  1-2 litre oras one can take maximum

iii.     Saltaddition: 2 TSF in 2 litre

 9. Withdrawalcriteria-

Theparticipant may withdraw from the trial if

i.     Volunteersdevelops any serious condition or adverse effect

ii.     Avolunteer wants to self withdrawal from the research

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

1.    How much air one canbreathe in (Inhale)

2.    How much air one canbreathe out (Exhale)

3.    How fast one can exhalethe air from lungs

**11.**Rescue Medicine:

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

permitted as per the need ofthe patient.

**12.**Assessment of adverseevents:

All subjects are to be questioned regarding adverseevents during treatment at       eachvisit. 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 followingparameters at the baseline and at the end of study using Spirometer.

 

Sr. No.

Name of parameters

Before Intervention

After Intervention

|1.

Slow Vital Capacity

(SVC)

   |2.

Inspiratory Reserve Volume (IRV)

   |3.

ForcedVital Capacity (FVC)

   |4.

Maximum Voluntary Ventilation (MVV)

   |5.

Peak Expiratory Flow

(PEF)

**14.**Time Of Assessment:-

1)    Baseline

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

15. StatisticalMethods For Analysis:

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

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

For Non- parametric data comparingtwo groups Mann-Whitney tests.