| CTRI Number |
CTRI/2023/05/053082 [Registered on: 23/05/2023] Trial Registered Prospectively |
| Last Modified On: |
23/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
This study is to understand how different causation of Psoriasis helps in deciding the management plans The two scales PASI and DQLI scale will help in assessing the response. |
|
Scientific Title of Study
|
EXPLORING THE ROLE OF DIFFERENT CAUSATION IN PLANNING MANAGEMENT STRATEGY OF PSORIASIS ASSESSING THE RESPONSE WITH THE HELP OF PASI ( PSORIASIS AREA AND SEVERITY INDEX ) & DLQI (DERMATOLOGY LIFE QUALITY INDEX ) SCALES EXPERIMENTAL UNCONTROLLED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShama Manoj Rao |
| Designation |
Professor Dept of Practice of Medicine |
| Affiliation |
Dr.M.L.Dhawale Memorial Homoeopathic Institute |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute
Boisar Road
Opposite S T stand
Palghar 401404
Dr M L Dhawale Memorial Homoeopathic Institute
Boisar Road
Opposite S T stand
Palghar 401404
Thane
MAHARASHTRA
401404
India |
| Phone |
9892212843 |
| Fax |
|
| Email |
rao.shama@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitesh G Purohit |
| Designation |
Principal and Professor and HOD Department of Materia Medica |
| Affiliation |
Smt Malini Kishore Sanghvi Homoeopathic Medical College |
| Address |
Smt Malini Kishore Sanghvi Homoeopathic Medical College
Karjan
Opposite Sumeru Navkar Tirth
Amod Road
Miyagam Karjan
Vadodara 391240
Smt Malini Kishore Sanghvi Homoeopathic Medical College
Karjan
Opposite Sumeru Navkar Tirth
Amod Road
Miyagam Karjan
Vadodara 391240
Vadodara
GUJARAT
391240
India |
| Phone |
9376939622 |
| Fax |
|
| Email |
drhiteshp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShama Manoj Rao |
| Designation |
Professor Dept of Practice of Medicine |
| Affiliation |
Dr.M.L.Dhawale Memorial Homoeopathic Institute |
| Address |
201 A wing Alok Apartment Mahant Road Vile Parle East Mumbai 400057
Dr M L Dhawale Memorial Homoeopathic Institute
Boisar Road
Opposite S T stand
Palghar 401404
Thane
MAHARASHTRA
400057
India |
| Phone |
9892212843 |
| Fax |
|
| Email |
rao.shama@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr M L Dhawale Memorial Homoeopathic Institute
Palghar Boisar Road
Opposite S T Workshop
Palghar 401404
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr M L Dhawale Memorial Homoeopathic Institute |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute
Boisar Road
Opposite S T Stand
Palghar 401404
|
| Type of Sponsor |
Private medical college |
|
|
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 Shama Rao |
Dr M L Dhawale Memorial Homoeopathic Institute |
Boisar Road
Opposite S T Stand
Palghar 401404
Ground Floor OPD Number 135
Department Of Practice Of Medicine
Room Number 5 Second Floor
Thane
MAHARASHTRA |
9892212843
rao.shama@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt Malini ishore Sanghvi Homoeopathic Medical College & Hospital Karjan Vadodara |
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 |
| Intervention |
HOMOEOPATHIC INDICATED MEDICINE FOR EACH INDIVIDUAL PATIENT AFTER DETAILED CASE TAKING OF EACH OF THEM AS THE MEDICATIONS MAY VARY DEPENDING ON THE SYMPTOMS OF EACH INDIVIDUAL PATIENT
Indicated Homoeopathic Acute or Chronic or Intercurrent medicine |
Indicated Homoeopathic Acute or Chronic or Intercurrent medicine
Dose potency 200.
One dose per week will be used to start with for first thee months. As per the response Repetation may be reviewed. Route of administration would be oral
Duration of therapy 18 months. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients belonging to all sex and age group from 10 to adult.
Cases of Psoriasis where the remedy has registered its action assessed by adequate subjective and objective parameters (Scales attached)
Cases of Psoriasis with minimum 6 months of follow up
Patients on allopathic medication already but willing to stop that & shift to Homoeopathy & continue Homoeopathic treatment. If patient is on steroids washout period will not be applicable. Sudden stopping of local or systemic steroids will not become possible in any patient as it may lead to sudden increase in intensity of symptoms. So slowly tapering will have to be done. The tapering of allopathic medications will be done with the help of M.D. Physician. If any other applications like Salysalic acid cream, then no washout period. |
|
| ExclusionCriteria |
| Details |
If high doses of systemic steroids or Methotrexate given for long duration
Patients suffering from other autoimmune diseases
Patients on immunosuppressive therapies e.g. chemotherapy for cancer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Possible management strategies in different presentations of Psoriasis based on Fundamental or Precipitating or Maintaining causation |
2 years 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will contribute to expand & sharpen Homoeopathic Materia Medica knowledge as some conclusions can be drawn after studying various cases of psoriasis |
2 years 9 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/07/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recruitment of samples will start approximately from 15 th February 2023 after the CTRI approval Samples will be chosen as per inclusion & exclusion criteria Samples will be taken from MLDMHI centers |