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
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