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CTRI Number  CTRI/2024/10/075677 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pranic Healing as an Add-On Therapy for Managing Pain and Enhancing Well-being in Diabetic Neuropathy 
Scientific Title of Study   Effects of Integrated Pranic Healing as Complementary Therapy on Pain management and Overall Wellbeing among patients with Peripheral Neuropathy in type 2 Diabetes: A Randomized Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manasa B 
Designation  Consultant Psychologist 
Affiliation  World Pranic Healing Foundation, India 
Address  Room no 2, Research Centre 44, First Floor, 4th Main, 1st Cross Rd, Saraswathipuram, Mysuru

Mysore
KARNATAKA
570009
India 
Phone  9901502828  
Fax    
Email  manasabelal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish Darla 
Designation  Diabetologist  
Affiliation  Darlas Health Care 
Address  Room No 1, No 20,7th Main, Swimming pool road, Saraswathipuram, Mysore

Mysore
KARNATAKA
570009
India 
Phone  09901502828  
Fax    
Email  drbharishkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Srikanth Jois Nagaraja  
Designation  Head of Research 
Affiliation  World Pranic Healing Foundation, India  
Address  Room no 3, Research Centre 44, First Floor, 4th Main, 1st Cross Rd, Saraswathipuram, Mysuru

Mysore
KARNATAKA
570009
India 
Phone  9901502828  
Fax    
Email  srikanth@pranichealing.co.in  
 
Source of Monetary or Material Support  
World Pranic Healing Foundation, India Dharsons, no 12, First floor, Hospital Road, Shivajinagar, Bengaluru 560001 Karnataka, India 
 
Primary Sponsor  
Name  World Pranic Healing Foundation India 
Address  12, First Floor, Dharsons, Hospital Road, Shivajinagar, Bengaluru 560001, Karnataka, India 
Type of Sponsor  Other [Trust ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Harish Darla  Darlas Health Care  20, 7th, Main, Swimming Pool Rd, Saraswathipuram, Mysuru
Mysore
KARNATAKA 		 9164288885

drbharishkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee, World Pranic Healing Foundation, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Treatment  Pregabalin 75 mg, Alpha-Lipoic Acid, Vitamin B complex for 5 weeks. 
Intervention  Conventional Treatment + Pranic Healing.  Conventional Treatment (Pregabalin 75 mg, Alpha-Lipoic Acid, Vitamin B complex + Complementary therapy of Pranic Healing (20 minutes session twice weekly) for 5 weeks. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants must provide written informed consent to participate in the study.
2. Male and female participants aged between 30 and 60 years.
3. Subjects with a clinical diagnosis of Type 2 diabetes
4. Peripheral neuropathy diagnosed using Semmes-Weinstein Monofilament (SWM)
Test and Biothesiometry:
5. Having a history of peripheral neuropathy from onset to 9 years
 
 
ExclusionCriteria 
Details  1. Subjects with other neurological conditions that affect hand function (e.g., stroke,
multiple sclerosis, carpal tunnel syndrome, or someone with excessive alcoholic
consumption (more than 21 units per week for men/ more than 15 units for women)
will be excluded.
2. Subjects diagnosed with heart disease, renal failure with stage 3 and stage 4, severe
hepatic disease, and diabetic foot ulcer.
3. Subjects with type 1 diabetes
4. Subjects with known vitamin B12 deficiency
5. Pregnant, and lactating women will be excluded.
6. Subjects with serious psychiatric disorders, or cognitive impairments that could affect
their ability to follow the study protocol will be excluded.
7. Subjects who have had recent surgery or trauma affecting the extremities will be excluded.
8. Those who are participating in any other clinical trial or interventional study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Relieve in pain symptoms as per Neuropathic Pain Symptom
Inventory score 		 0, 5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
reductions in scores of Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)
weeks 		 0, 5 weeks 
Reductions in worry scores using Penn State Worry Questionnaire  0, 5 weeks 
Enhance in the score of Modified Diabetes Quality
of Life scale 		 0, 5 weeks 
Improvement in Vibration Perception Threshold based on Biothesiometry test  0, 5 weeks 
Improved sensory nerve conduction velocity based on
mean score of Semmes-Weinstein Monofilament (SWM) 		 0, 5 weeks 
Improved hand grip strength based on the mean score
of the TTM Original Dynamometer 		 0, 5 weeks 
reduction in FBS and PPBS  0, 5 weeks 
Temperature balance in both feet   0, 5 weeks 
An open-ended questionnaire will be used for interviews with participants from the Pranic Healing group. The interviews will be recorded, transcribed, and then analyzed.  5 weeks 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [research@pranichealing.co.in].

  6. For how long will this data be available start date provided 27-08-2025 and end date provided 01-08-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Diabetic peripheral neuropathy, a common complication of diabetes, significantly impairs quality of life due to sensory pain, motor dysfunction, and associated difficulties in daily activities. This condition affects up to 50% of diabetics, leading to complications such as foot ulcers and increased disability. Lifelong medication for diabetic peripheral neuropathy (DPN) often involves the use of drugs like Neuropathic Pain Agents to manage pain. While these medications can relieve pain and discomfort, they do not cure DPN or halt its progression. Additionally, long-term use may lead to tolerance, requiring higher doses to achieve the same effect, potentially increasing side effects. This study evaluates the effectiveness of integrated pranic healing (PH) as a complementary therapy for diabetic peripheral neuropathy (DPN). This study compares pranic healing combined with medical therapy (MEDPH) against medical therapy alone (MED) in terms of its impact on various outcomes. These include pain, psychological well-being, vibration perception threshold, functional health capacity, blood glucose level and temperature. Eligible participants will be recruited for the study according to specified inclusion and exclusion criteria and will be randomly assigned to one of two groups. One group will receive standard treatment along with Pranic Healing, while the other group will receive standard treatment alone. Both groups will undergo pre- and post-intervention assessments and analyse the collected data. Participant’s experiences with Pranic Healing will be explored through structured interviews, incorporating open-ended questions. Feedback will be analysed using qualitative content analysis.

 
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