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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  
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 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  
Status 
Not Applicable 
 
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. 
 
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