| CTRI Number |
CTRI/2024/07/070518 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study the Effectiveness of Homoeopathy in Reducing the Severity of Skin Disorders in which Mental Symptoms are Etiological or Exacerbating Factors Among Pediatric Age group |
|
Scientific Title of Study
|
A Clinical Study to Estimate the Effectiveness of Homoeopathy in Reducing the Severity of Psychocutaneous Disorders Among Paediatric Age group |
| 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 Ria Grace Devasia |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari. |
| Address |
ROOM NO.409, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College Kulasekharam, Kanniyakumari.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9946979244 |
| Fax |
|
| Email |
riagrace96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sisir P R |
| Designation |
Professor and HOD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
ROOM NO.409, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College Kulasekharam, Kanniyakumari.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443474941 |
| Fax |
|
| Email |
hodpd@skhmc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sisir P R |
| Designation |
Professor and HOD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
ROOM NO.409, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College Kulasekharam, Kanniyakumari.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443474941 |
| Fax |
|
| Email |
hodpd@skhmc.org |
|
|
Source of Monetary or Material Support
|
| Institution -Sarada Krishna Homoeopathic Medical College Kulasekharam, Kanniyakumari,Tamil Nadu - 629161 |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada Krishna Homoeopathic Medical College Kulasekharam, Kanniyakumari,Tamil Nadu - 629161 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ria Grace Devasia |
Sarada Krishna Homoeopathic Medical College |
ROOM NO.409, Department of Paediatrics
Kanniyakumari
TAMIL NADU |
9946979244
riagrace96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Institution -Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
1 dose through oral method will be given. the patient will be asked for regular follow up every 2 weeks once. the research will be done for the period of 3 months |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
The sample of both sexes from infancy to 18 years will be taken
Patients having symptomatology of psychocutaneous disorder.
Informed consent to treatment.
|
|
| ExclusionCriteria |
| Details |
Cases above 18 years of both sexes.
Patients suffering from other severe systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A Decrease in Severity of Symptoms will Serve as a means for Assessing Progress |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the role of mental symptoms as etiological and exacerbating factors in skin disorders. |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The prevalence of psychosomatic disorders among dermatological patient is high but frequently unreported because of difficulties in diagnosing and treating this patient group. This study is conducted to establish the role of mental symptoms as etiological and exacerbating factors in skin disorders and study the scope of acute ,constitutional and intercurrent medicines in the treatment of psychocutaneous diseases. The study is done by taking the case and recording it in standardized and pre-structured case format of Sarada Krishna Homoeopathic medical college and analysis and evaluation of symptoms will be done and homoeopathic medicine according to symptom similarity will be prescribed. Assesment of the cases will be based on the disappearance or relief of symptoms before and after the treatment. |