| CTRI Number |
CTRI/2023/09/058058 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
24/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Individualised Homoeopathic medicine in centesimal potencies versus LM potencies in cases of psoriasis |
|
Scientific Title of Study
|
An analytical comparison of individualised homoeopathic medicine in centesimal potencies versus LM potencies for the management of psoriasis |
| 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 Amit Nayak |
| Designation |
PhD Homoeopathy Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Room No: 402
Organon of medicine
PG Department, Parul University
At Post: Limda, Ta: Waghodia
Dist: Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8141598111 |
| Fax |
|
| Email |
amit33nayak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Heena Rawal |
| Designation |
Academic Director, Ahemedabad Campus, Parul University |
| Affiliation |
Ahemedabad Homoeoapathic Medical College |
| Address |
Room No: 23
Ahemedabad Homoeopathic Medical College
Bopal - Ghuma Rd, Opposite Kabir Complex, South Bopal, Bopal, Ahmedabad
Vadodara
GUJARAT
380058
India |
| Phone |
9427401176 |
| Fax |
|
| Email |
heena.rawalahmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Nayak |
| Designation |
PhD Homoeopathy Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Room No: 402
Organon of medicine
PG Department, Parul University
At Post: Limda, Ta: Waghodia
Dist: Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8141598111 |
| Fax |
|
| Email |
amit33nayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical Hospital
Address: At Post: Limda, Ta: Waghodia
Dist: Vadodara
Pin code: 391760 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Amit Nayak |
Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University |
room no: 110
Medicine OPD
At Post: Limda
Ta: Waghodia
Dist Vadodara-391760
Vadodara
GUJARAT |
8141598111
amit33nayak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L401||Generalized pustular psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized Homoeopathic medicine in Centesimal potencies |
Intervention is planned as administering indicated homoeopathic medicine in Centesimal potencies. In this potency a single medicated cane sugar globule of poppy seed size(no. 30) preserved in 90% v/v ethanol. Each dose will directed to be taken orally on clean tongue with empty stomach. dosage and repetition will be depending upon the individual requirement of the case.
Individual patient will receive treatment for 6 months. |
| Intervention |
Individualized Homoeopathic medicine in LM potencies |
Intervention is planned as administering indicated homoeopathic medicine in LM potencies. In this potency a single medicated cane sugar globule of poppy seed size(no. 10) preserved in 90% v/v ethanol. Each dose will directed to be taken orally on clean tongue with empty stomach. dosage and repetition will be depending upon the individual requirement of the case.
Individual patient will receive treatment for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnosed or cases having clinical features of Psoriasis.
Cases of Psoriasis seeking treatment from any other system of medicines like Allopathy, Ayurvedic, etc., will be considered after a washout period of 1 month.
Patients seeking Homoeopathic treatment prior to the visit will also be taken into consideration after 1 month of washout period.
Adult age group 18 years to 65 years.
The patients giving their consent to participate in study with six follow ups. |
|
| ExclusionCriteria |
| Details |
The psoriasis cases with other comorbidities.
The psoriasis cases with psoriatic arthritis.
Participants with other co-existing skin conditions.
Pregnant and Lactating mother.
The case without proper follow-up and discontinuation of treatment in between the study will be dropped out. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare individualised homoeopathic medicine in centesimal potencies versus LM potencies the management of psoriasis. |
3rd Month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To clinically assess treatment outcome in cases of psoriasis using Psoriasis Area & Severity Index (PASI)
|
3rd Month, 6 Month |
| To study the role individualised homoeopathic medicine in psoriasis |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 |
|
Date of First Enrollment (India)
|
05/10/2023 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Psoriasis is a chronic inflammatory, hyper
proliferative, skin disease.
It is characterized by well-defined erythematous,
scaly plaques, itching and erythema, particularly affecting extensor surfaces
and scalp, usually follows relapsing and remitting course.
According to ETHealthWorld (October 31, 2022, 06:44
IST), The prevalence rate of psoriasis is around 2 – 4 % in the western world,
whereas in India it is around 1 -2 %. It is also alarming to note that the
prevalence of the disease is increasing in developing countries also. Hahnemann in his 6th edition
of Organon of Medicine mentioned the new method of preparation of
medicines i.e. renewed dynamization or fifty millesimal (LM) potencies which
caused less aggravation in comparison to centesimal (CM) potencies, where the
patient had to wait as long as they were improving even in the slightest manner
after single dose of medicine. A analytic randomized exploratory
study designed to compare the effectiveness of
homoeopathic medicines in LM verses CM potencies
|