An open labelled single arm clinical study on combined effect of Padabhyanga and Pranayama in Nidranasha(Primary insomnia)

NAME OF THE DEPARTMENT- DEPARTMENT OF SWASTHAVRITTA

NAME OF THE STUDENT- Dr. AKSHAY B HIREMATH

NAME OF THE GUIDE- Dr. GURUBASAVARAJ. YALAGACHIN MD (AYU)

TITLE OF THE STUDY-

AN OPEN LABELLED SINGLE ARM CLINICAL STUDY ON COMBINED EFFECT OF PADABHYANGA AND PRANAYAMA IN NIDRANASHA

SUMMARY-

Sleep is one of the most significant human behavior, occupying roughly one third of human life.

It is the state of mind during which it blocks all the perception from the external world. Qualitative

sleep is the essential component of good health. Disturbed sleep leads to discomfort and diseases,

can be identified as longer time taken to fall asleep, more periods of wakefulness during the night,

and time spent lying awake before rising in the morning. . The reported prevalence of insomnia is

33% in the general population globally ,and 16% in india and18.6% in south india.

Most commonly recommended tranquilisers and sedatives for the treatment of insomnia are associated with plethora of adverse effects such as confusion, psychomotor performance deficits, nocturnal falls, dysphoric mood, impaired intellectual functioning, muscle weakness and even coma.

Nidra being called as AdharaneeyaVega is also emphasized as sub pillar of human life as per Ayurveda purview. It is the special state of mind in which absolute detachment of all Indriyas from Bahya Vishayas due to tiredness in body and mind. Padabhyanga as a part of Dinacharya is said to induce sound sleep and Pranayama not only enhances Pranashakti but also calms down the stress on body and mind. Hence in the current study, the combined effect of Padabhyanga&Pranayana practice among elderly population is attempted as remedial measures.

OBJECTIVES-

TO evaluate the combined effect of padabhyanga and pranayama in nidranasha

METHODOLOGY: Interventional clinical study

INTERVENTION:

1.Padabhyanga                                           :  20-25 ml of TilaTaila is used for Padabhyanga at bed time.

Pranayama                                               :

1.A,U,M, OM  Chants- 10 times each

2. Loosening exersises

3.Anulomana,vilomana each 10 times

4.Nadishuddhi pranayama 10 times

5. SheetaliPranayama     10 times

6. SheetkariPranayama   10 times

7.Bhramari pranayama    10 times

8.Shantimantra

Time for pranayama                               :  Morning

Duration                                                 :   30 DAYS

Follow up during the treatment             :  15th  AND 30th

Follow up after the treatment                :   Nil

RESEARCH DESIGN

In the present study 30 patients fulfilling the criteria for inclusion will be selected with convenience sampling technique. The selected patients will be open label single arm interventional study.

SOURCE OF DATA

• Subjects from OPD /IPD of SDM Ayurveda Hospital Hassan  • Residents of old age homes of Hassan

SAMPLING TECHNIQUE: Convenient sampling  method and treated in single group.

A) SAMPLE SIZE: 30.

DIAGNOSTIC CRITERIA:

1.Guidelines mentioned in ICD-10 will be followed:

a) A complaint of difficulty in falling asleep, maintaining sleep, or non-refreshing sleep.

b) The sleep disturbance occurs at least three times per week for at least one month.  c) The sleep disturbance results in marked personal distress or interference with       personal functioning in daily living.          2. For diagnosis, detailed medical history will be taken according to both Ayurvedic and

Modern clinical methods.

ASSESSMENT CRITERIA

Subjective parameters:

Sl/no Parameters/lakshana Yes / No

1.  Jrumbha

2.  Angamarda

3.  Tandra

4.  Akshigourava

5.  Shirogourava

Objective parameters

will be made on basis of assessment criteria developed and validated scale (insomnia severity index) on 0,15 and 30 day of treatment.15.

0–7 = No clinically significant insomnia.  8–14 = Sub threshold insomnia  15–21 = Clinical insomnia (moderate severity)

22–28 = Clinical insomnia (severe)

INCLUSION CRITERIA

1 Age between 20 to 70 years

2. Who are willing to participate.

3. Mild to moderate grading of scale

Exclusion Criteria:

1. Subjects indulged in night shift jobs

2. Subjects addicted to tobacco and alcohol 3. Known case of systemic diseases