| CTRI Number |
CTRI/2026/01/100148 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ozone Therapy on Diabetes Patients |
|
Scientific Title of Study
|
Effect of Ozone Therapy as an adjuvant to Conventional Medicine on HbA1C, FBS, PPBS, and QOL in Type 2 Diabetes Mellitus |
| Trial Acronym |
A Randomized Control Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arkaprava Das Adhikary |
| Designation |
PG SCHOLAR |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Maharishi Aurobindo Subharti Naturopathy College and Hospital of Naturopathy and Yogic Sciences
Subharti University, NH-58, Delhi Haridwar Bypass Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7044626313 |
| Fax |
|
| Email |
dr.arkaprava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAIR DHIREN AJIT |
| Designation |
AssociateProfessor and Post Graduate (PG) coordinator |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University, Subhartipuram Meerut, UTTAR PRADESH, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nair Dhiren Ajit |
| Designation |
Oficiating Principal |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University, Subhartipuram Meerut, UTTAR PRADESH, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Arkaprava Das Adhikary (Researcher) |
|
|
Primary Sponsor
|
| Name |
Dr. Arkaprava Das Adhikary |
| Address |
MD Naturopathy- Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University, Subhartipuram, NH58 Delhi Haridwar Bypass Road, Meerut, Uttar Pradesh- 250005 |
| Type of Sponsor |
Other [Self] |
|
|
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 Arkaprava Das Adhikary |
Swami Vivekanand Subharti University |
Subhartipuram, NH58- Delhi Haridwar Bypass Road
Meerut
UTTAR PRADESH |
7044626313
dr.arkaprava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) swami vivekanand subharti 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 |
| Comparator Agent |
Conventional Management |
The patient will be informed to take regular diabetic medications. |
| Intervention |
Rectal Insufflations mixture of Oxygen and Ozone |
Administration of diabetic medication alobng with a medical ozone–oxygen mixture through the rectal route following a structured, stepwise dosage protocol that progressively increases concentration and volume over ten sessions, starting from 1000 mcg in the first session to a maximum of 4500 mcg by the ninth and tenth sessions. During the procedure, the patient is positioned in the left lateral decubitus posture to enhance comfort and minimize discomfort. After adequate lubrication with ozonated oil, a number 8 infant feeding tube or a number 9 urethral PVC catheter is gently inserted up to approximately four inches into the rectum. The ozone–oxygen gas mixture is then delivered using either a rectal oxy-bag or a 60 ml syringe, with gradual administration achieved by gentle compression of the bag or repeated syringe refilling, typically two to three times. The flow rate is carefully maintained at around 120 ml per minute to ensure optimal concentration while preventing back pressure, with the entire procedure lasting approximately 3–4 minutes, followed by 2–3 minutes of supine rest to facilitate absorption. The gas mixture is generated using a medical-grade ozone generator (O3-Ozonics Generator, Ozone Forum of India), which provides a standardized and automated ozone concentration ranging from 0.5% to 5% with corresponding oxygen levels of 99.5% to 95%, ensuring consistency, safety, and precision throughout the therapy. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient is willing to participate
History of type 2 diabetes mellitus for the past 1 year
Depending on oral or parenteral hypoglycemic medications
Zubrods performance status is 0–2 |
|
| ExclusionCriteria |
| Details |
Acute alcohol intoxication
A recent myocardial infarction
Haemorrhage from any organ
Pregnancy
Hyperthyroidis
Thrombocytopenia
Severe anaemia
Ozone allergy
Serious Cardio-Vascular instability
Patients on Angiotensin-converting enzyme(ACE) inhibitors
G6PD deficiency |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemoglobin A1C (HbA1c). |
Pre and post assessment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting Blood Glucose |
Pre and post assessment |
| Postprandial blood glucose. |
Pre and post assessment. |
| Quality of life |
Pre and post assessment. |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A study to find the impact of ozone therapy as an adjunct treatment on glycated hemoglobin among patients with type 2 diabetes mellitus and to test the hypothesis of how ozone therapy helps in the management of Type 2 diabetes mellitus. |