| CTRI Number |
CTRI/2024/09/073411 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effects of Ozone Therapy on Blood Parameters and Psoriasis Severity: Results from a Randomized Control Trial |
|
Scientific Title of Study
|
Effect Of Ozone Therapy On Hematological Parameters & PASI Score In Psoriasis Control 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 |
Ujjwal Tripathi |
| Designation |
Under Graduate Student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences Subharti University Subhartipuram Meerut UTTAR PRADESH India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9887542690 |
| Fax |
|
| Email |
ujjwalt.014@gmil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAIR DHIREN AJIT |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Maharishi Aurobindo Subharti College And Hospital Of Naturopathy & Yogic Sciences, Swami Vivekanand Subharti University Subhartipuram, NH-58 Delhi-Haridwar Bypass Road Meerut-250005, Uttar Pradesh
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 |
Assistant Professor |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences 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
|
| Department of
Dermatology in Chhatrapati Shivaji Subharti Hospital and Department of Yoga and Naturopathy Maharishi Aurobindo Subharti College & Hospital Of Naturopathy & Yogic Sciences Meerut, U.P, India
Pin: 250005 |
|
|
Primary Sponsor
|
| Name |
Ujjwal Tripathi |
| Address |
Maharishi Aurobindo Subharti College And Hospital Of Naturopathy & Yogic Sciences, Swami Vivekanand Subharti University Subhartipuram, NH-58 Delhi-Haridwar Bypass Road Meerut-250005, Uttar Pradesh |
| 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 Ujjwal Tripathi |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy & Yogic Sciences |
Maharishi Aurobindo Subharti College And Hospital Of Naturopathy & Yogic Sciences, Third Floor Room no.1 Treatment section, Swami Vivekanand Subharti University Subhartipuram, NH-58 Delhi-Haridwar Bypass Road Meerut-250005, Uttar Pradesh
Meerut
UTTAR PRADESH |
9887542690
ujjwalt.014@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: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
OXYGEN |
The procedure of oxygen therapy bagging involves several detailed steps. First, the patient is positioned comfortably, and the treatment area, such as a limb affected by psoriasis, is exposed, with any interfering clothing or accessories removed. An oxygen generator is then set up to produce medical-grade oxygen. The generator must be properly calibrated and maintained to ensure accurate oxygen delivery and safe operation.
Next, a specialized bag or chamber made of appropriate materials is used to enclose the treated area, ensuring airtight seals to prevent the escape of oxygen gas. The oxygen gas is introduced into the bag or chamber at a specified concentration and volume as determined by the treatment protocol. Throughout the therapy session, the oxygen concentration is monitored to ensure it remains within the desired range.
During the therapy session, the patients comfort and safety are closely monitored, with any signs of discomfort or adverse reactions being promptly addressed.
Finally, after the therapy session is complete, the bag or chamber is opened, and the oxygen gas is allowed to dissipate and ventilate the treatment area. Proper ventilation is essential to ensure the safe removal of excess oxygen from the environment.
The duration of the oxygen therapy session can vary depending on the treatment protocol and the patients condition, typically lasting from 20-30 minutes, with sessions conducted twice a week for a total of 10 sittings. |
| Intervention |
OZONE THERAPY |
The procedure of ozone therapy bagging involves several detailed steps. First, the patient is positioned comfortably, and the treatment area, such as a limb affected by psoriasis, is exposed, with any interfering clothing or accessories removed. An ozone generator from the Ozone Forum of India in Mumbai, Maharashtra, is then set up to produce ozone gas from medical-grade oxygen. The generator must be properly calibrated and maintained to ensure accurate ozone concentrations and safe operation.
Next, a specialized bag or chamber made of ozone-resistant materials is used to enclose the treated area, ensuring airtight seals to prevent the escape of ozone gas or using a destructor to destroy any escaping ozone. The ozone gas, at a concentration of 52 micrograms per milliliter (µg/ml) with a total volume of 20-50 mL, is introduced into the bag or chamber. Throughout the therapy session, the ozone concentration is monitored to ensure it remains within the desired range.
During the therapy session, the patients comfort and safety are closely monitored, with any signs of discomfort or adverse reactions, such as skin irritation or respiratory distress, being promptly addressed.
Finally, after the therapy session is complete, the bag or chamber is opened, and the ozone gas is allowed to dissipate and ventilate the treatment area. Proper ventilation is essential to ensure the safe removal of ozone gas from the environment.
The duration of the ozone therapy session can vary depending on the treatment protocol and the patients condition, typically lasting from 20-30 minutes, with sessions conducted twice a week for a total of 10 sittings. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Both |
| Details |
PASI Score 5 to 10 (MODERATE)
Total Body Surface Area (BSA) affected 3% to 10% Subjects who are willing to participate in the study Patients with no other comorbidity |
|
| ExclusionCriteria |
| Details |
All cases with blood coagulation failure
Subjects with bleeding organs
Pregnancy
Breastfeeding
Malignancy
Any substance abuse
Subjects on drugs(Aspirin, anticoagulants drugs)
Thrombocytopenia
Ozone Allergy and intolerance
Menstrual Periods |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PASI and BSA |
Before And After Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological Parameters (CBC and ESR) |
Before And After Intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/09/2024 |
| 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="1"
Days="5" |
|
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 - NO
|
|
Brief Summary
|
A randomized control trial to find the effect of ozone therapy (bagging) on hematological parameters and PASI, BSA score in psoriasis patients. |