| CTRI Number |
CTRI/2022/01/039754 [Registered on: 27/01/2022] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
ROLE OF HOMOEOPATHIC MEDICINES IN THE CASES OF ECZEMA |
|
Scientific Title of Study
|
EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN THE CASES OF ECZEMA : A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PARUL SINGH |
| Designation |
MD PGR Department of MATERIA MEDICA |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10-A, Sitapura Istitutional Area, Sitapura, Tonk Road, Jaipur
Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10-A, Sitapura Istitutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7733098017 |
| Fax |
01412771009 |
| Email |
parul19singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogeshwari Gupta |
| Designation |
M.D. (HOM.) PRINCIPAL, HoD of MATERIA MEDICA |
| Affiliation |
Dr. S. R Rajasthan ayurved university jodhpur |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,10-A, Sitapura Istitutional Area, Sitapura, Tonk Road, Jaipur
Kadvad, Nagaur road, Jodhpur, Rajasthan, 342037
Jodhpur
RAJASTHAN
302022
India |
| Phone |
9414229555 |
| Fax |
01412771009 |
| Email |
principalskhmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogeshwari Gupta |
| Designation |
M.D. (HOM.) PRINCIPAL, HoD of MATERIA MEDICA |
| Affiliation |
Dr. S. R Rajasthan ayurved university jodhpur |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,10-A, Sitapura Istitutional Area, Sitapura, Tonk Road, Jaipur
Kadvad, Nagaur road, jodhpur, 342037
Jodhpur
RAJASTHAN
302022
India |
| Phone |
9414229555 |
| Fax |
01412771009 |
| Email |
principalskhmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College and Research Centre |
|
|
Primary Sponsor
|
| Name |
Parul Singh |
| Address |
Swasthya kalyan homoeopathic medical college and research centre, 10-A Sitapura Institutional Area, Sitapura, Tonk Road, Jaipur |
| 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 |
| Parul Singh |
OPD of our Swasthya Kalyan Homoeopathic Medical College and Research Centre |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,10-A Sitapura Institutional Area, Sitapura, Tonk Road, Jaipur.
Jaipur
RAJASTHAN |
7733098017
01412771009
parul19singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee S. K. Homoeopathic Medical College and Research Centre, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 New and pre diagnosed cases of eczema
2 Persons suffering from itchy scaly eruptions, vesicular eruptions of all age group and
both sexes
3 The patients having either of spongiosis, hyperkeratosis or acanthosis
4 The patients having 3 or more than 3 marks in POEM |
|
| ExclusionCriteria |
| Details |
1 Pregnant and lactating females
2 Cases with other systemic disorders like HIV, Hepatitis, malignancies etc
3 Patients requiring hospitalization or surgical intervention due to other systemic
disease with eczema.
4 Patients having score 2 or less than 2 marks in POEM |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness would be assessed by using POEM scale |
POEM Scale will be applied at the base line and at the end of 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Formation of Homoeopathic Therapeutic Compendium for the treatment of Eczema |
a list of most indicated homoeopathic medicines for eczema will be form in one year of study duration |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
Modification(s)
|
22/02/2022 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial is conducting to ascertain the role of Homoeopathic Medicines in the cases of Eczema. In this trial I will study 63 cases of Eczema treated with Individualized Homoeopathic Medicine on the basis of totality of case. For the assessment Patient Oriented Eczema Measure Scale (POEM ) will be applied pre treatment and at the end of 3 month. At the end of one year of study duration we will be able to form Homoeopathic Compandium for the treatment of Eczema. |