| CTRI Number |
CTRI/2024/03/064810 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ozone steam in psoriasis patients |
|
Scientific Title of Study
|
Efficacy of ozonated steam in patients with psoriasis- 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 |
Dr Annu |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Aurobindo College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Flat no.106 ground floor Greenwood City Godwin, Near Subharti University, NH 58 Delhi Haridwar Bypass Road, Meerut 250005, Uttar Pradesh, India
Meerut UTTAR PRADESH 250005 India |
| Phone |
8791809373 |
| Fax |
|
| Email |
dr.annusingh2410@gmail.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 |
Swami Vivekanand Subharti University, NH 58 Delhi Haridwar Bypass Road, Meerut 250005, Uttar Pradesh, India
Meerut UTTAR PRADESH 250005 India |
| Phone |
789943619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhay M Shankar Gowda |
| Designation |
Principal and Dean |
| Affiliation |
Maharishi Aurobindo College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Swami Vivekanand Subharti University, Subhartipuram NH 58 Delhi Haridwar Bypass Road, Meerut 250005, Uttar Pradesh, India
Meerut UTTAR PRADESH 250005 India |
| Phone |
9448300347 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University, Meerut 250005 |
|
|
Primary Sponsor
|
| Name |
Dr Annu |
| Address |
Flat no.106 ground floor Greenwood City Godwin, Near Subharti University, NH 58 Delhi Haridwar Bypass Road, Meerut 250005, Uttar Pradesh, India |
| 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 Annu |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Swami Vivekanand Subharti University, Subhartipuram NH 58 Delhi Haridwar Bypass Road, Meerut 250005, Uttar Pradesh, India Meerut UTTAR PRADESH |
8791809373
dr.annusingh2410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
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 |
CONVENTIONAL TREATMENT |
Topical creams and Oral medication |
| Intervention |
OZONATED STEAM |
Requirements -
1. A steam chamber.
2. The oxygen source is connected to the ozone generator.
3. Masks and towels to protect patients from breathing ozone.(37)
Procedure -
The individual will be asked to drink 1-2 glasses of water, be in minimal clothing and sit in the steam chamber. The steam chamber will be connected to ozone machine and the patient body will be exposed to ozone at the concentration of 50mg/ml for the duration of 10-30 mins. After therapy, patient will go under the shower on alternate days (10 sessions) over 20 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who met diagnostic criteria.
Based on clinical sign and symptoms.
Willing to participate. |
|
| ExclusionCriteria |
| Details |
Menstruating females.
Pregnancy.
Breast feeding.
Those who are taking corticosteroids.
Multiple systemic diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Psoriasis Area and Severity Index |
PRE AND POST TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| C-reactive protein serum level |
PRE AND POST TREATMENT |
|
|
Target Sample Size
|
Total Sample Size="102" Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
27/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Psoriasis is a long-term (chronic) disease in which the body’s immune system becomes overactive, causing abnormal skin cell multiplication at a rapid rate. Skin patches rise to scaly and inflamed, most commonly on the scalp, elbows, or knees, but other parts of the body can also be affected. It is an immune system-mediated inflammatory illness that places a significant financial and quality-of-life burden on patients. It is a systemic disease that arises from the intricate, nonlinear interactions between a person’s biological makeup (genetic/epigenetic components) and environmental exposure (such as exposure to infectious agents). Prevalence of psoriasis in worldwide is about 2%, but varies according to country. A clinical trial in North India found that 1.4% of 782 dermatology outpatients were diagnosed with psoriasis. The study showed a higher prevalence in men compared to women. Severity was similar between genders, with three-quarters of patients having over 50% of body surface area affected. Approximately 7.4% of patients had a family history, and their age of onset was noticeably younger than those without a family history. If one parent has psoriasis, each child has a 25% chance of being affected. Psoriasis has five main types: plaque psoriasis, guttate or eruptive psoriasis, inverse psoriasis, pustular psoriasis, and erythrodermic psoriasis. Plaque psoriasis is the most common, accounting for over 90% of cases. Conventional management for psoriasis-
1. Topical therapies (ointments, creams, gels) - Vitamin D3, Analogues, Corticosteroids (betamethasone and hydrocortisone), Anthralin/Dithranol, Topical Retinoids.
2. Phototherapy (UV light therapy)
3. Systemic therapies (Tablets, Injections, or Infusion) - Methotrexate, Ciclosporin, Acitretin, Biologic Agents, Oral Small Molecules CAM (complementary and alternative medicine) is a widely known alternative method to conventional medicine that is used in specific populations around the world, such as herbal treatments in Asians and Ayurveda in Indians. Herbal therapy, vitamins, Ayurveda, naturopathy, homeopathy, and traditional healing were the most commonly used complementary and alternative medicine (CAM) for the treatment of eczema. Panchamahabhuta is the oldest tool for analyzing the universe. Based on such analysis, some Indian scientists claim that the universe is made up of five major elements. They are Akasha, Vayu, Agni, Jala, and Prithvi, and they are known as Panchamahabhuta. According to Charaka, the human body is made of panchamabhutas, which means that everything in the universe is also present in the human body. Akasha of the universe is the cause of vacuums in the body; Vayu is the cause of movement; Agni is the cause of temperature; Jala is the cause of fluidity; and Prithvi is the cause of solidity. Prithvi is the most recent of the Panchamahabhutas. Akasha was the first to appear, followed by Vayu mahabhuta, and then Agni and Jala mahabhuta. Prithvi Mahabhuta is the most recent. Ozone therapy, initially used for psoriasis, was tested in 1988 at the University’s Dermatology Institute. Despite initial improvements, the study failed due to low ozone concentrations. Though plenty of advances have been done since then in understanding immunologic abnormalities associated with psoriasis. Two studies in Autoimmune Diseases show that the administration of two antibodies, etanercept and efalizumab, has shown exceptional improvement in patients’ mental states, but the long-term effects of these unnatural antibodies, which disrupt immunologic homeostasis, are not yet known. This will reiterate previous advice for autoimmune diseases: CD4+ Tregs should be increased while the auto-reactive cytotoxic cell clone should be suppressed. During a six-month cycle of therapy, at least two major AHTs will be administered, with ozone concentrations gradually increasing from 30 to 80 mcg/ml over five weeks. The evidence suggests there is a strong case for further research on ozone therapy to determine its efficacy and safety, as long as the studies are rigorous and well-designed. While some evidence indicates ozone therapy may contribute to improved quality of life and reduced pain, infections, inflammation, and wounds, more high-quality research is required to establish its effectiveness for various conditions. The goal should be to fill the evidence gap through methodical clinical trials, enabling evidence-based practice regarding the appropriate uses of ozone therapy as a potential integrative treatment option. If effectiveness and safety are confirmed, ozone therapy may merit wider adoption given its low cost and apparent lack of severe side effects. |