Hypothesis Generating Pilot Study on the

Effects of Pranic Healing on Chronic Obstructive Pulmonary Disease

Randomized Control Trial, Double Blind Placebo Control

Dr. Mahesh P. A.

World Pranic Healing Foundation

Research Center

Dr. Mahesh P. A.Mr. Srikanth N. Jois

Dr. Anantha Krishna M. S.Dr. Chaya S. K.

Hypothesis Generating Pilot Study on the

Effects of Pranic Healing on Chronic Obstructive Pulmonary Disease

Randomized Control Trial, Double Blind Placebo Control

Dr. Mahesh P. A.

World Pranic Healing Foundation- India

Research Center

Dr. Mahesh P. A.Mr. Srikanth N. Jois

Dr. Anantha Krishna M. S.Dr. Chaya S. K.

Chronic Obstructive Pulmonary Disease

COPD is one of the most important

causes of morbidity and mortality.

It has been estimated that by 2020

COPD will be the third leading

cause of death and fifth most

common cause of morbidity in the

world.

Chronic Obstructive Pulmonary Disease

Objectives

The objective of this study is to apply complementary therapy of Pranic Healing to

• Reduce COPD Symptoms by

• Increase subject participation in physical and social activities

• Decrease pulmonary disability

• Promote independence and improve quality of life

• Reduce the number of hospitalizations, thereby reducing overall healthcare costs

Objectives

The objective of this study is to apply complementary therapy of Pranic

Increase subject participation in physical and social activities

Promote independence and improve quality of life

Reduce the number of hospitalizations, thereby reducing overall

Randomization: One in two participants has an equal chance of getting the healing session.

Double Blind: Both the patient and the doctor don't know whether subject doctor don't know whether subject is receiving the treatment or placebo

Placebo Control; In addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designed to the treatment group but also to have no real effect.also to have no real effect.

Hawthorne effectIs a type of reactivity in which individuals improve an aspect of their behaviour in response to their awareness of being

observed.

Medication

Patients from both groups are given the standard of care for COPD according to GOLD guidelines practised throughout the world.

- Tiotropium

- Inhaled Salbutamol

Duration of Study

One year conducted in two phases

Patients from both groups are given the standard of care for COPD according to GOLD guidelines practised throughout the world.

One year conducted in two phases

Incentives

WPHF,I RC has paid study participants

Informed consent

It is a process for getting permission before conducting a healthcare intervention on a person.

WPHF,I RC has paid study participants Rs. 300/visit for lost work time

Ethics committee Permission

Research activities started after obtaining authorisation Ethics committee

Insurance

Professional indemnity

Confidentiality

Will not be sharing the identity ofthose participating in the researchwith anyone.

Professional indemnity insurance for Rs. 10,00,000/-

Clinical Trail Registry- India

Registration of trials will ensure

transparency, accountability and

accessibility of clinical trials

Inclusion criteria:

- Male Patients diagnosed with COPD Stage 2

- Diagnosis of COPD according to GOLD criteria.

- with in the age group of 40 to 75 years.

- Able to give informed consent.

Participant selection

- Able to give informed consent.

- Able to perform all study related procedures.

- Smoker for at least 10 pack years.

- Absence of other major co morbidities

- Current smokers

Male Patients diagnosed with COPD Stage 2

Diagnosis of COPD according to GOLD criteria.

with in the age group of 40 to 75 years.

Able to give informed consent.

Participant selection

Able to give informed consent.

Able to perform all study related procedures.

Smoker for at least 10 pack years.

Absence of other major co morbidities

Flow Chart

Base line Medical and

Other assessments

Base line treatment

2nd Visit

Screened & Consented

1st Visit-

Medical and

Other assessments

3rd Visit

Control Group

15 patients

Medical and

Other assessments

6th Visit-

Medical and

Other assessments

4th Visit- 14 week

Medical and

Other assessments

5th Visit- 27 week

15 patients

Medical and

Other assessments

7th Visit

art

Base line Medical and

Other assessments

Base line treatment

Visit - 2 week

Screened & Consented

Visit- 1 week

Medical and

Other assessments

Visit- 6 week

Pranic Healing

Group

Medical and

Other assessments

Visit- 39 week

Group

15 patients

Medical and

Other assessments

Visit -52 week

Medical and

Other assessments

4th Visit- 14 week

Medical and

Other assessments

5th Visit- 27 week

Information, Consenting and ScreeningInformation, Consenting and Screening

Pulmonary Function Test

Arterial Blood Gas *

Chest X Ray *

Medical Tests & Other Assessments

ECG *

HB, PCV, TC, DC, AEC, RBS *

* NABL Accredited laboratory# ATS standard

Pulmonary Function Test #

Arterial Blood Gas *

Chest X Ray *

Medical Tests & Other Assessments

ECG *

HB, PCV, TC, DC, AEC, RBS *

* NABL Accredited laboratory# ATS standard

Other Assessments

6 Minutes walk Test & Oxygen Saturation

The Hamilton Rating Scale for Depression

St. George's Respiratory questionnaire

Other Assessments

6 Minutes walk Test & Oxygen Saturation

The Hamilton Rating Scale for Depression

St. George's Respiratory questionnaire

Pranic Healing and Sham Pranic Healing Sessions conducted

at Study Site

Pranic Healing and Sham Pranic Healing Sessions conducted

at Study Site

Pranic Healing Protocol was applied as thought by Master Choa Kok Sui in Advanced

Pranic Healing book

Healing session were applied at Grama Panchayat premises

Doctors visit to Study Sites Doctors visit to Study Sites

PFT-FEV1 (Post%)

Pulmonary Function Test

50

60

70

80

0

10

20

30

40

1 Visit 2 Visit 3 Visit

Control Group

Pranic Group

FEV1 (Post%)

Pulmonary Function Test

3 Visit 4 Visit 5 Visit

Control Group

Pranic Group

Six Minutes Walk Test (% of Pred)

62

64

66

68

70

52

54

56

58

60

62

2 Visit 3 Visit 4 Visit

Six Minutes Walk Test (% of Pred)

Control Group

4 Visit 5 Visit

Control Group

Pranic Group

St George's Respiratory Questionnaire

Symptoms

A 4 point difference is considered clinically significant

Impact

St George's Respiratory Questionnaire

Activity

A 4 point difference is considered clinically significant

Total

Hamilton Rating Scale for Depression

8

10

12

14

16

0

2

4

6

2 Visit 3 Visit 4 Visit

Hamilton Rating Scale for Depression

Control Group

Pranic Group

4 Visit 5 Visit

Pranic Group

Conclusion Conclusion

Thank You Thank You

©Copyright - World Pranic Healing Foundation.

It is mandatory for all those who display the slides for non-private purpose or in public places and/or commercial establishmentcommercial establishments, to take prior written approval from World Praniccontacted at wphf@pranichealing.co.in.

Thank You Thank You

private purpose or in public places and/or commercial establishments and/or non-Pranic Healing Foundation. World Pranic Healing Foundation can be