Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/02/2020
Date assigned
18/02/2020
Last edited
17/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
Suspended
Publication status
Results

Plain English Summary

Background and study aims
Nerve damage (diabetic neuropathy), is common in some Diabetic patients suffering from Diabetes for a long time. Nerve damage can lead to numbness, pain and weakness in the affected area of the body. Neuropathy in the soles of the feet is more common than anywhere else. The wounds developed in the soles of Diabetic patients are termed as Diabetic Foot Ulcers (DFUs). Diabetic Foot Ulcers can be treated through conventional methods but might keep recurring due to the loss of sensation in the soles. Diabetic Neuropathy is not easily treated in conventional therapies and needs holistic management of the metabolic disorder itself and possible regeneration of nerves in soles of patients suffering from Diabetic Neuropathy and Diabetic Foot Ulcers.

The objective of the study is to clinically establish the role of energy (Pranic) healing as complementary therapy in the management of Diabetic Foot Ulcers (DFUs) in Wagner classification Grade 1 - 3. Wagner scale classifies the wounds depending on their depth and severity. A lower grade implies a superficial wound and a higher grade implies a wound that had gone deep.

Who can participate?
Diabetic patients (men and women) in the age group of 25 - 75 years, visiting the super-speciality referral centre and presenting with Diabetic Foot Ulcers in Wagner scale 1-3 can enrol for the study. Pregnant women and smokers will be excluded.

What does the study involve?
The study involves Pranic healing treatment as complementary therapy in the management of Diabetic Foot Ulcers (DFUs) in Wagner classification Grade 1-3. Half of the participants recruited will be allocated to the trial group i.e Pranic Healing intervention along with standardised medical care for Diabetes and optimum wound care. The other half will be allocated to the control group; i.e. not receive Pranic healing as a complementary therapy, but only receive medical care for Diabetes and optimum wound care.
Pranic Healing protocols for Diabetes Type-2 and local wound healing and regeneration of nerves in the soles and Psychotherapy for stress will be undertaken for the participants in the trial group.

What are the possible benefits and risks of participating?
The possible benefits of enrolling in the study are accelerated wound healing in terms of size and area of the wound, wound bed appearance, sensory changes in the soles, better glycemic control and reduced stress.
There has been no side effect of energy (Pranic) healing to date.
Risks:
• Thromobosis/ other complications while drawing blood for tests
• Infection of wound, high blood sugar levels, cardiovascular complications
• Patients not following instructions and assuming that the intervention is supposed to replace the conventional treatment

Where is the study run from?
Karnataka Institute of Endocrinology & Research (India)

When is the study starting and how long is it expected to run for?
September 2019 to November 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Anuradha Nittur
anuradha2nittur@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Ms Anuradha Nittur

ORCID ID

http://orcid.org/0000-0003-1724-2762

Contact details

Mantri Woodlands
Arekere Layout
Bannerghatta Road
Bangalore
560076
India
+91 8888913348
anuradha2nittur@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

A randomised, double-blind, comparative pilot study to assess the efficacy of short term pranic healing as a complementary therapy in diabetic foot ulcer management in men and women in the age group of 25-75

Acronym

COMPDIAM-DFU

Study hypothesis

Short term Pranic Healing intervention can play a significant role in providing complimentary therapy in managing Diabetic Foot Ulcers in patients suffering from diabetes

Ethics approval

Approved 14/09/2019, Institutional Ethical Committee, Karnataka Institute of Endocrinology & Research (KIER) (SJICR Campus , Bannerghatta Road, 9th Block, Jayanagar, Bengaluru-560069, India; +918026647222; ieckier2017@gmail.com ), ref: IEC-KIER 16/14.09.2019

Study design

Randomised, double-blind, comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See https://drive.google.com/drive/folders/120trMumZMmCHBYtcGAD1z9NPKjfQe5uJ?usp=sharing

Condition

Diabetic foot ulcers, stress, and nerve regeneration in soles in diabetic patients

Intervention

Pranic Healing protocols for Diabetes Type-2, local wound healing and regeneration of nerves in the soles and Psychotherapy for stress will be followed. Participants will be randomly selected, informed and assigned to the trial or control (no treatment) group as per a computerised random table.

The subjects in the trial group will be provided complimentary healing in the form of Pranic Healing - a no-touch, no-drug energy healing modality every day for 50 - 60 minutes along with standardised wound care and medication for diabetes and co-morbidities for five weeks.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Size and severity of Diabetic Foot Ulcer measured using pictures of the wounds taken on recruitment and at the end of the trial and wound area compared either through the wound zoom camera or using Image J software which will be examined by the clinician and measurements and characteristics noted at recruitment and end of the trial
2. Improved sensation in soles measured through Monofilament and Vibratory Perception Threshold tests using last available reading before the start of the trial and measured at the end of the trial
3. Stress, general well being and appetite measured by means of a questionnaire administered at the end of the trial

Secondary outcome measures

Glycemic level measured through Hba1c or FBS tests using last available reading before the start of the trial and measured at the end of the trial

Overall trial start date

08/08/2019

Overall trial end date

16/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Men and women in the age group of 25 - 75 years
2. Presence of diabetic foot ulcers in Wagner grade 1 - 3

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Total final enrolment

30

Participant exclusion criteria

1. Pregnant women
2. Smokers

Recruitment start date

16/09/2019

Recruitment end date

12/10/2019

Locations

Countries of recruitment

India

Trial participating centre

Karnataka Institute of Endocrinology & Research
Sri Jayadeva Institute of Cardiovascular Sciences and Research Campus Bannerghatta Road 9th Block Jayanagar
Bangalore
560069
India

Sponsor information

Organisation

Center for Pranic Healing

Sponsor details

420 Valley Brooke Avenue
Lyndhurst
New Jersey
07071
United States of America
+1 512-953-7474
info@PranicHealingResearch.com

Sponsor type

Other

Website

https://www.pranichealingresearch.com/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan to submit the report of the Pilot project for publication as soon as the registration is complete.The report is ready to be submitted in relevant peer reviewed journals.
This will hopefully be followed by a full fledged Clinical Trial.
The results of the pilot project will be shared in relevant medical Conferences and workshops.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

15/02/2020

Participant level data

Other

Basic results (scientific)

See additional file ISRCTN17141223_BasicResults_17Aug20 (added 17/08/2020)

Publication list

Publication citations

Additional files

Editorial Notes

17/08/2020: The basic results of this trial uploaded as an additional file have been updated. 13/08/2020: The following changes have been made: 1. The basic results of this trial have been uploaded as an additional file. 2. The total final enrolment number has been added. 12/05/2020: Due to current public health guidance, recruitment for this study has been paused. 24/02/2020: Uploaded protocol (not peer reviewed) as an additional file. 20/02/2020: Internal review. 19/02/2020: Internal review. 17/02/2020: Trial’s existence confirmed by Institutional Ethical Committee, Karnataka Institute of Endocrinology & Research (KIER)