| CTRI Number |
CTRI/2024/08/073094 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Management of Psoriatic Arthritis |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicine in the Management of Psoriatic Arthritis by using DAPSA
Score – A Prospective Clinical Interventional 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 |
Dr Anusree P B |
| Designation |
Post Graduate Scholar, Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy, Kottayam, Kerala, India.
Kottayam
KERALA
686532
India |
| Phone |
08138818400 |
| Fax |
|
| Email |
anusreepb77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Dastagiri |
| Designation |
Associate Professor/ Research Officer(H), Scientist 2, Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy,
Kottayam, Kerala, India.
Kottayam
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
|
| Email |
drdastagirinhrimh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Dastagiri |
| Designation |
Associate Professor/ Research Officer(H), Scientist 2, Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy, Kottayam, Kerala, India.
Kottayam
KERALA
686532
India |
| Phone |
9000444409 |
| Fax |
|
| Email |
drdastagirinhrimh@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy, Kottayam, Kerala, India. 686532 |
|
|
Primary Sponsor
|
| Name |
Dr Anusree P B |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy, Kottayam, Kerala, India. 686532 |
| 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 |
| Dr Anusree P B |
National Homoeopathy Research Institute in Mental Health, Kottayam |
OPD Room no. 2, IPD, Camps and peripheral units, Department of Practice of medicine, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy, Kottayam, Kerala, India. 686532
Kottayam
KERALA |
8138818400
anusreepb77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE- NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH, KOTTAYAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L405||Arthropathic psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
The individualized homoeopathic medicine with potency starting from 6C to 50M will be given orally, in 4 to 6 pills of number 30 size. The frequency of repetition will be in accordance with the follow up, done monthly. The period of intervention will be 12 months. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group of 18-65 years and of both genders.
Patients who fulfil the CASPAR criteria. |
|
| ExclusionCriteria |
| Details |
Patients with known conditions such as gout, osteoarthritis, rheumatoid
arthritis, etc.,
Patients having known severe structural deformity.
Pregnant and lactating women.
Patients with known advanced systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in DAPSA score baseline, 3
rd, 6th, 9th and 12th month for interpreting the
disease activity in psoriatic arthritis. |
Baseline, 3rd, 6th, 9th and 12th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the severity of skin lesions in psoriasis using PASI - baseline, 3rd, 6th, 9th & 12th month
Evaluation of disability using HAQ – DI baseline, 6th month & 12th month |
PASI baseline, 3rd, 6th, 9th & 12th month
HAQ - DI baseline, 6th month & 12th month |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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 |
|
Date of First Enrollment (India)
|
11/09/2024 |
| 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="6"
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
|
This study is an open label, single arm, clinical interventional study to determine the effectiveness of individualized homoeopathic medicines in the management of psoriatic arthritis by using DAPSA score that will be conducted in OPD, IPD, and peripheral units of department of practice of medicine at National Homeopathy Research Institute in mental health , kottayam , The primary outcome measure will be assessed using DAPSA score on baseline, 3rd, 6th, 9th and 12th month . The secondary outcome measures will be PASI and HAQ - DI . The changes in severity of skin lesions in psoriasis using PASI will be assessed on baseline, 3rd, 6th, 9th and 12th month. The evaluation of disability using HAQ-DI will be assessed on baseline, 6th and 12th month. As the study with the aforementioned domains is one of its kind , it aims to make the efforts to offer possibilities for future research in the effectiveness of Individualized Homoeopathic Medicine in the management of psoriatic arthritis in general . |