| CTRI Number |
CTRI/2025/10/095639 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of 12 Weeks Bhramari Pranayama on lungs health, Heart Health, and Wound Healing in People with Type 2 Diabetes"
|
|
Scientific Title of Study
|
To Study impact of 12 weeks of Bhramari Pranayama on serum nitric oxide levels, changes in cardio-pulmonary functions, and wound healing in adults with Type 2 Diabetic Mellitus. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh Saxena |
| Designation |
Professor (Physiology) |
| Affiliation |
Swami Rama Himalayan University |
| Address |
Department of Physiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan Institute, Swami Ram Nagar, Near Doiwala, Dehradun
Dehradun
UTTARANCHAL
248016
India |
| Phone |
9719904008 |
| Fax |
|
| Email |
drysaxena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Saxena |
| Designation |
Professor (Physiology) |
| Affiliation |
Swami Rama Himalayan University |
| Address |
Department of Physiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan Institute, Swami Ram Nagar, Near Doiwala, Dehradun
UTTARANCHAL
248016
India |
| Phone |
9719904008 |
| Fax |
|
| Email |
drysaxena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Saxena |
| Designation |
Professor (Physiology) |
| Affiliation |
Swami Rama Himalayan University |
| Address |
Department of Physiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan Institute, Swami Ram Nagar, Near Doiwala, Dehradun
UTTARANCHAL
248016
India |
| Phone |
9719904008 |
| Fax |
|
| Email |
drysaxena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himalayan institute of Medical Sciences, Swami Rama Himalayan University, Swami Ram Nagar, Jolly Grant, Dehradun, 248016 |
|
|
Primary Sponsor
|
| Name |
Swami Rama Himalayan University |
| Address |
Swami Ram Nagar, Jolly Grant Dehradun - 248016, Uttarakhand, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemant Kumar Nautiyal |
Himalayan Hospital |
Department of General Surgery, Swami Ram Nagar
Jolly Grant
Doiwala
Dehradun
UTTARANCHAL |
9410507100
drnauty1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swami Rama Himalayan University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bhramari Pranayama with conventional treatment |
Yoga intervention of 25 minutes per session, five days a week, for a total duration of 12 weeks.” |
| Comparator Agent |
Conventional treatment |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults with diabetes mellitus type 2.
2) Grade 1 ulcers as per wagner classification.
3) Hba1c levels greater than equal to 6.5 |
|
| ExclusionCriteria |
| Details |
1) History of active ear infection, low blood pressure, or epilepsy
2) Severe respiratory disorders (acute or chronic), chest wall injuries/deformities
3) Congestive cardiac failure (CHF) |
|
|
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 |
| Serum Nitric Oxide(NO), Respiratory Function, Cardiovascular function and wound healing |
Serum Nitric Oxide- (0, 2, 6 and 12 weeks) Respiratory and Cardiovascular function (0, 6 and 12 weeks) and wound healing (0 and 12 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Flow and HRV |
Blood Flow and HRV (0, 6 and 12 week) |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
15/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - Participant comprehensive data after the the results are reported in specific publication arising out of trial
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drysaxena@gmail.com].
- For how long will this data be available start date provided 30-09-2025 and end date provided 30-09-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This Single-Blinded, Parallel-Group Randomized Controlled Trial aims to evaluate the impact of a yoga-based intervention, Bhramari Pranayama, on ulcer wound healing, as well as cardiovascular and pulmonary health, in patients with Type 2 Diabetes Mellitus. Eligible patients presenting with diabetic ulcers will be recruited from the Department of Surgery, Himalayan Hospital, Dehradun, India. Participants in the intervention arm will receive a 12-week structured Bhramari Pranayama program, while both the intervention and control groups will continue to receive standard allopathic treatment. The Outcomes will be assessed using the Leg Ulcer Measurement Tool (LUMT) for wound healing, Doppler Ultrasound for vascular function, Heart Rate Variability (HRV) for cardiovascular health, Spirometry for pulmonary function, and Serum Nitric Oxide (NO) Levels to evaluate underlying physiological mechanisms. This study is expected to provide evidence on the effectiveness of Bhramari Pranayama as a complementary therapy for improving wound healing and overall health in patients with Type 2 Diabetes Mellitus. |