| CTRI Number |
CTRI/2018/03/012615 [Registered on: 16/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Trial on WEL/PSO-01 Capsules in Psoriasis. |
|
Scientific Title of Study
|
An Open Label, Single Arm, Multi-center, Prospective, Clinical Study to Evaluate Efficacy and Safety of WEL/PSO-01 in patients suffering from Chronic Plaque Psoriasis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WLX/PSO-01, Version 1.0, Dated 09th Dec 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay N Kulkarni |
| Designation |
Ayurved consultant and Secretary |
| Affiliation |
Ayurveda Research Center |
| Address |
Ayurveda Research Center 2nd floor Ayurveda Seva Sangh Ganeshwadi Nasik Maharashtra
Ayurveda Research Center 2nd floor Ayurveda Seva Sangh Ganeshwadi Nasik Maharashtra
Mumbai (Suburban)
MAHARASHTRA
422003
India |
| Phone |
7774844739 |
| Fax |
|
| Email |
abhaynk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai
Target Institute of Medical Education and Research
205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Bade |
| Designation |
Manager - Clinical Trial Operation |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
8149507065 |
| Fax |
|
| Email |
vandana@targetinstitute.in |
|
|
Source of Monetary or Material Support
|
| Welex Laboratories Pvt. Ltd.
1002, Marathon Innova Nextgen,
Off Ganpatrao kadam marg,
Lower Parel, Mumbai -13 |
|
|
Primary Sponsor
|
| Name |
Welex Laboratories Pvt Ltd |
| Address |
1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -13 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay N Kulkarni |
Ayurveda Research Center Ayurved Seva Sangh Ganeshwadi Nashik |
Ayurveda Research Center 2nd floor Ayurveda Seva Sangh
Ganeshwadi Nasik 422003
Maharashtra
Nashik
MAHARASHTRA |
7774844739
abhaynk@yahoo.com |
| Dr Mrs Anura P Bale |
College of Gomantak Ayurved Mahavidyalay & Research Centre Shiroda Goa |
Ground Floor, Hospital Building College of Gomantak Ayurved Mahavidyalay & Research Centre Shiroda Goa403103
North Goa
GOA |
9822589751
baleanura@rediffmail.com |
| Dr Pavan Kumar Godatwar |
National Institute of Ayurveda Jaipur |
Department of Roganidana and Vikriti Vijnana First Floor National Institute of Ayurveda Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN |
9314502834
gpawankumar@rediffmail.com |
| Dr Shailesh Deshpande |
PDEAs College of Ayurvedic and Research Centre, Nigdi |
Department of Kayachikitsa
PDEAs College of Ayurvedic and Research Centre Sector 25 Pradhikaran Nigdi Pune 411044
Pune
MAHARASHTRA |
9763104451
dr.shaileshd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee College of Ayurved & Research Centre, Nigdi, Pune |
Approved |
| Institutional Ethics Committee National Institute of Ayurveda, Jaipur |
Approved |
| Institutional Ethics Committee, College of Gomantak Ayurved Mahavidyalay & Research Centre |
Approved |
| Institutional Ethics Committee, ASS Ayurved Mahavidyalay Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Plaque Psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
WEL/PSO-01 Capsule |
WEL/PSO-01 Capsule contains Acacia catechu, Holarrhena antidysenterica, Azadirecta indica, Smilax china, Swertia chirata, Posoralea coryfolia, Picrorhiza kurroa, Hemidesmus indicus, Rubia cordifolia, Eclipta alba, Fumaria parviflora, Curcuma Longa, Alstonia scholaris, Androgrphis Paniculata, Phyllanthus emblica
Dosage and Treatment Duration: 2 Capsules twice daily orally after meals for 3 months (90 days). After 3 months of treatment, subjects will be asked to come for follow ups for next 1 month to observe relapse / recurrence of psoriasis symptoms |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with confirmed diagnosis of plaque psoriasis since at least 6 months
2. Subjects with plaque psoriasis having PASI score more than 10.
3. Subjects of female gender or non-pregnant, non-lactating females. A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is more than 2 years postmenopausal.
4. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who have received systemic treatment for Psoriasis such as Methotrexate or Cyclosporine therapy or any conventional systemic treatment for more than 4 weeks one month prior to screening in the study.
2. Any laser dermatological procedure, 4 weeks prior to screening in this study.
3. Known cases of Severe or Chronic hepatic or renal disease.
4. Known case of any active malignancy.
5. Subjects giving history of significant cardiovascular event less than 12 weeks prior to recruitment.
6. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
7. Subjects participating currently or 1 month prior to recruitment in any other clinical study.
8. Known hypersensitivity to any of the ingredients used in study drug.
9. Pregnant and Lactating females.
10. Any other condition due to which patients are deemed to be unsuitable by the investigator‘s opinion for reason(s) not specifically stated in the exclusion criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of changes in PASI Score.
2. Assessment of Clinical Photographic changes in psoriasis lesions (Scaling, Intensity and Thickness)
|
Day-7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of quality of life on Dermatology Life Quality Index
2 Assessment of change in Overall Disease Severity
3 Assessment of Changes in Pruritus Score
4 Assessment of relapse of Psoriasis
5 Assessment of Adverse Drug Reaction and post-treatment clinically significant abnormal laboratory parameters.
6 Physician‘s and subject‘s Global Assessment for overall change at the end of study.
7 Global assessment of overall safety of WEL/PSO-01 as per subject and physician. |
Day-7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 120 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/02/2018 |
| Date of Study Completion (India) |
05/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It
is an open label, single arm, multi-center, prospective, clinical study to evaluate
efficacy and safety of WEL/PSO-01 in patients suffering from chronic plaque psoriasis. The study will be conducted at three sites in
India. Subjects will be
advised to take 2
WEL/PSO-01 Capsules twice daily orally after meals for 3 months (90 days).
After 3 months of treatment, subjects will be asked to come for follow ups after
1 month to observe relapse / recurrence of psoriasis symptoms. The primary objective of study is to evaluate changes
in PASI Score and clinical Photographic changes in psoriasis lesions (Scaling,
Intensity and Thickness). The secondary objectives will be assessment of quality
of life on Dermatology Life Quality Index, assessment of change in Overall
Disease Severity, assessment of Changes in Pruritus Score on the Visual
Analogue Scale, assessment of relapse of Psoriasis after 30 days of cessation
of treatment, assessment of Adverse Drug Reaction and post-treatment clinically
significant abnormal laboratory parameters, physician‘s and subject‘s Global
Assessment for overall change at the end of study and global assessment of
overall safety of WEL/PSO-01 as per subject and physician |