| CTRI Number |
CTRI/2017/05/008559 [Registered on: 15/05/2017] Trial Registered Prospectively |
| Last Modified On: |
15/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of psoriasis (a chronic skin disease) |
|
Scientific Title of Study
|
Clinical audit using Psoriasis Disability Index (PDI) and Psoriasis Area and Severity Index (PASI) for utility of homoeopathic medicine in psoriasis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1196-5611 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anaitulah Ahmad Mir |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD No. 13, Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9419039499 |
| Fax |
|
| Email |
civildefence12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhijit Chatterjee |
| Designation |
Reader and Head, Dept. of Homoeopathic Materia Medica |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept. of Homoeopathic Materia Medica, National Institute of
Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
|
| Fax |
|
| Email |
drac.nih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhijit Chatterjee |
| Designation |
Reader and Head, Dept. of Homoeopathic Materia Medica |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Dept. of Homoeopathic Materia Medica, National Institute of
Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
|
| Fax |
|
| Email |
drac.nih@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt of India; Block GE, Sector III, Salt
Lake, Kolkata 700106, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy Ministry of AYUSH Govt of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata, West Bengal 700106, India |
| Type of Sponsor |
Government 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 |
| Anaitulah Ahmad Mir |
National Institute of Homoeopathy, Govt. of India |
OPD Room no. 13, Dept. of Homoeopathic Materia Medica, National Institute of
Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, India;
Monday to Saturday, 9
am to 2 pm
Kolkata
WEST BENGAL |
9419039499
civildefence12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic
medicine in centesimal or 50
millesimal potencies |
In centesimal potencies, each dose shall consist of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 88% v/v ethanol. In 50 millesimal
potencies, a single medicated cane sugar globules of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 88% v/v ethanol, 10 doses marked on the vial, each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean
cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Repetition 24, 12 or 8 hourly or even oftener, depending upon the individual requirement of the case. Each dose to be taken orally on clean tongue in empty stomach. Duration of therapy: 6 months |
| Comparator Agent |
None |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from psoriasis over 3 months
2. Age 18-60 years
3. Both sexes
4. Patients willing to take part in the study and giving written consent |
|
| ExclusionCriteria |
| Details |
1. Patients who are too sick for consultation
2. Unable to read patient information sheets and not giving consent to take part
3. Psoriasis with complications like erythroderma and pustules
4. Diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life
5. Currently receiving homeopathic treatment for chronic condition(s)
6. Pregnant and lactating women
7. Self-reported immune-compromised state
8. Substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Psoriasis Area Scoring Index (PASI) |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Psoriasis Disability Index (PDI) |
Baseline and 6 months |
| Dermatological Quality of Life Index (DQLI) |
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/05/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Psoriasis is currently understood as an immune system disturbance with inflammatory skin manifestation. Chronicity and lack of causal therapies lead to permanence of physical and psycho-social suffering, increased costs, and frequent dissatisfaction with offered treatments. Treatment must be sustained to prevent rebounds, placing a burden of side-effects, toxicity, and possible long-term risks. In situations like this, patients tend to look for alternative approaches such as homeopathy. Unfortunately, the efficacy and effectiveness of homeopathy in psoriasis treatment has not been researched well so far. In this clinical audit, the investigator intends to assess the utility of individualized homoeopathic treatment in 100 patients suffering from psoriasis. Patients will be enrolled in this observational trial from the outpatients of National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India from May 2017 onward. Primary outcome is Psoriasis Area and Severity Index (PASI). Secondary outcomes are Psoriasis Disability Index (PDI) and Dermatological Quality of Life Index (DQLI). All the outcomes are to be measured at baseline and after 6 months. The generated results will be analyzed and will be published in scientific journals. |