| CTRI Number |
CTRI/2024/07/071070 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
New Hope for Treating Psoriasis (a Chronic Skin Disease) with Homeopathy and Ozonated Water Spray |
|
Scientific Title of Study
|
The efficacy of application of ozonated water along with indicated Homoeopathic medicine in Psoriasis Vulgaris using the PASI score: A Randomized Control Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anandkumar Shantilal Patel |
| Designation |
Professor HOD Repertory Department |
| Affiliation |
Shri Govind Guru University |
| Address |
Repertory Department
Pioneer Homoeopathic Medical College and Hospital
Sayajipura
Vadodara
Shri Govind Guru University
Vinzol
Godhra
Gujarat
388713
Panch Mahals
GUJARAT
390019
India |
| Phone |
9898888530 |
| Fax |
|
| Email |
dr.anandpatel@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alpesh Arunbhai Shah |
| Designation |
Principal Professor Organon Department |
| Affiliation |
Shri Govind Guru University |
| Address |
Principal Professor Organon Department
Pioneer Homoeopathic Medical College and Hospital
Sayajipura
Vadodara
Shri Govind Guru University
Vinzol
Godhra
Gujarat
388713
Panch Mahals
GUJARAT
390019
India |
| Phone |
9825487564 |
| Fax |
|
| Email |
vrajdev@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anandkumar Shantilal Patel |
| Designation |
Professor HOD Repertory Department |
| Affiliation |
Shri Govind Guru University |
| Address |
Professor HOD Repertory DepartmentPioneer Homoeopathic Medical College and Hospital
Sayajipura
Vadodara
Shri Govind Guru University
Vinzol
Godhra
Gujarat
388713
Panch Mahals
GUJARAT
390019
India |
| Phone |
9898888530 |
| Fax |
|
| Email |
dr.anandpatel@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr Anandkumar Shantilal Patel
Professor HOD Repertory Department
Pioneer Homoeopathic Medical College and Hospital
Sayajipura
Vadodara
Gujarat
INDIA
390019 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [N A] |
|
|
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 Anandkumar Shantilal Patel |
Pioneer Homoeopathic Medical College and Hospital. |
Room no. 108
Pioneer Homoeopathic Medical College and Hospital
Sayajipura
Vadodara
Gujarat
INDIA
390019
Vadodara
GUJARAT |
9898888530
dr.anandpatel@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt Malini Kishore Sanghavi Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Indicated Homoeopathic remedy |
In centesimal potencies, each dose shall consist of 4 cane sugar globules medicated with a single drop of the indicated medicine.
At Baseline and every 3 months, up to 12 months of study period. |
| Intervention |
Indicated Homoeopathic remedy and ozonated water |
In centesimal potencies, each dose shall consist of 4 cane sugar globules medicated with a single drop of the indicated medicine.
Ozonated water spray or shower
Freshly prepared.
At Baseline and every 3 months, up to 12 months of study period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with psoriasis
With a duration of at least 3 months
Patients willing to take part in the study and giving written consent |
|
| ExclusionCriteria |
| Details |
Currently receiving treatment from others
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Psoriasis Area and Severity Index (PASI) score for efficacy study |
Baseline, every 3 months, up to 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Psoriasis Area and Severity Index (PASI) score and demographic variables study |
Baseline, every 3 months, up to 12 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1"
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 - NO
|
|
Brief Summary
|
PhD Thesis. This study investigates the efficacy of applying ozonated water along with indicated homeopathic medicine for treating Psoriasis vulgaris. The treatment effectiveness is assessed using the PASI score at baseline and at three-month intervals over twelve months. The goal is to establish the efficacy of Homoeopathic treatment with ozonated water spray in the treatment of psoriasis.
|