| CTRI Number |
CTRI/2020/06/025658 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
01/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARISON OF EFFICACY AND SAFETY OF KAYA KALPA VATI AND SEABUCK THORN OIL WITH ORAL METHOTREXATE AND TOPICAL STEROID IN CHRONIC PLAQUE PSORIASIS |
|
Scientific Title of Study
|
A PROSPECTIVE, RANDOMIZED COMPARATIVE, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KAYA KALPA VATI AND SEABUCK THORN OIL IN COMPARISION WITH ORAL METHOTREXATE AND TOPICAL STEROID IN CHRONIC PLAQUE PSORIASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr Savita Agrawal |
| Designation |
Associate Professor |
| Affiliation |
National institute of medical science |
| Address |
NIMS hospital
jaipur delhi highway
jaipur, rajasthan
Jaipur
RAJASTHAN
303121
India |
| Phone |
9509097801 |
| Fax |
|
| Email |
drshilpysavi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr Savita Agrawal |
| Designation |
Associate Professor |
| Affiliation |
National institute of medical science |
| Address |
NIMS hospital
jaipur delhi highway
jaipur, rajasthan
Jaipur
RAJASTHAN
303121
India |
| Phone |
9509097801 |
| Fax |
|
| Email |
drshilpysavi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Sharma |
| Designation |
Principal, Nims |
| Affiliation |
National institute of medical science |
| Address |
National institute of medical science and research
Jaipur Delhi highway
Jaipur
Jaipur
RAJASTHAN
303121
India |
| Phone |
|
| Fax |
|
| Email |
drmeenaxi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of medical science and research centre, Jaipur Delhi highway, Shobha nagar, Jaipur, Rajasthan, 303121 |
|
|
Primary Sponsor
|
| Name |
National Institute of Medical Sciences and Research Centre |
| Address |
NIMS Hospital
Jaipur Delhi highway
Jaipur, Rajasthan, 303121 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Patanjali Yogpeeth |
Patanjali Yogpeeth
Haridwar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr Savita Agrawal |
National Institute of Medical Science and Research |
OPD no 2, Skin Department
Jaipur
RAJASTHAN |
9509097801
drshilpysavi@yahoo.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 |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
KAYA KALPA VATI AND SEABUCK THORN OIL |
Kaya kalpa Vati, 2 tab per oral twice daily for 16 weeks.
Sea buck thorn oil twice daily application over skin lesion for 16 weeks |
| Intervention |
ORAL METHOTREXATE AND TOPICAL STEROID |
Tablet Methotrexate , 15 mg, 1 tab per oral per week for 16 weeks.
Mometasone cream twice daily application over skin lesion for 16 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with chronic plaque psoriasis.
2.Psoriasis of both sex and age group more than 18 years.
3.All newly diagnosed and old cases of psoriasis.
4.Patients with PASI(psoriasis area severity index) score above10-12.
5.Patients with involvement of >10% body surface area. |
|
| ExclusionCriteria |
| Details |
1. Patient who do not give consent for the study.
2. Patient on any therapy of psoriasis for past 3 months.
3.Patient having any other chronic debilitating diseases or other chronic skin disorders. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in PASI score
Improvement in DLQI |
8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in PASI score
Improvement in DLQI |
16 weeks |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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 4 |
|
Date of First Enrollment (India)
|
10/06/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised interventional trial to compare the safety and efficacy of kaya kalpa Vati 2 tab thrice daily and sea buck thorn oil twice application with oral methotrexate 15mg once weekly and topical mometasone cream twice application for 16 weeks in 122 patients with chronic plaque psoriasis that will be conducted in NIMS Jaipur in India. The primary outcome measures will be reduction in PASI and improvement in DLQI at 8 weeks. The secondary outcome will be reduction in PASI score and improvement in DLQI at 16 weeks. |