CTRI Number |
CTRI/2017/09/009908 [Registered on: 25/09/2017] Trial Registered Retrospectively |
Last Modified On: |
23/09/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To evaluate effect of Cutisora Oil and Cutisora Tablet in patients of Psoriasis. |
Scientific Title of Study
|
A Randomized open labelled,parallel group study to evaluate the safety and efficacy of Cutisora oil and tablet in fixed dose as well as in combination therapy in patients with mild to moderate 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 Rajesh Sood |
Designation |
Reader |
Affiliation |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola |
Address |
P.G. Deptt. of Samhita avum Siddhant, Skin Care Unit OPD Number 715
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola
District Kangra (HP)
Kangra HIMACHAL PRADESH 176115 India |
Phone |
9418102424 |
Fax |
01894-242064 |
Email |
drrajeshsood@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajesh Sood |
Designation |
Reader |
Affiliation |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola |
Address |
P.G. Deptt. of Samhita avum Siddhant, Skin Care Unit OPD Number 715
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola
District Kangra (HP)
Kangra HIMACHAL PRADESH 176115 India |
Phone |
9418102424 |
Fax |
01894-242064 |
Email |
drrajeshsood@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rajesh Sood |
Designation |
Reader |
Affiliation |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola |
Address |
P.G. Deptt. of Samhita avum Siddhant, Skin Care Unit OPD Number 715
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola
District Kangra (HP)
Kangra HIMACHAL PRADESH 176115 India |
Phone |
9418102424 |
Fax |
01894-242064 |
Email |
drrajeshsood@gmail.com |
|
Source of Monetary or Material Support
|
vasu Research Centre
896/A. GIDC Makarpura, Vododra 390010 |
|
Primary Sponsor
|
Name |
Vasu Research Centre |
Address |
A Division of Vasu Healthcare Pvt. Ltd. 896/A, GIDC, Makarpura, Vadodra - 390010 |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
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 Rajesh Sood |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola |
OPD Number 715,Skin Care Unit, P.G. Deptt. of Samhita avum Siddhan, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola District Kangra (HP)
176115 Kangra HIMACHAL PRADESH |
9418102424
drrajeshsood@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Instititinal Ethical Commitee, Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Suffering from mild to moderate psoriasis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Cutisora oil |
ngredients- Azadirachta indica oil,Pongamia pinnata oil,Curcuma longa oil,Piper nigrum oleoresin
Mode of administration- external application over lesion
Dose- 2 times a day. |
Comparator Agent |
Cutisora Oil and tablets combination |
Dose : External application of oil two times a day, two tablets of ctisora 600 mg two times a day |
Intervention |
Cutisora tablets |
Ingradients- Wrightia tinctoria 65mg, Tinospora cordifolia 50mg,Adhatoda vasica 50mg, Acacia catechu 25mg,Azadirachta indica 50mg,Trichosanthes dioica 50mg, Solanum xanthocarpum 50mg,Plumbago zeylanica 25mg, curcuma longa 25 mg
Dose - 2 tablets each 600 mg two times a day with water |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Mild to moderate psoriasis
Psoriasis area and severity index of less than 20
Clinical chemistry and hematology results from visit 1 are within normal limits.
Non pregnant female and must agree to use adequate method of contraception during the study. |
|
ExclusionCriteria |
Details |
Age less than 18 years and not more than 60 years
Evidence of alcohol or drug abuse
Evidence of unstable forms of psoriasis, including guttate, erthrodermic, exfoliative or pustular psoriasis.
Psoriasis area and severity index of more than 20
patients suffering from any critical disease of vital organs and chronic diseases like cancer, AIDS,TB etc. |
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
Change in the psoriasis area and severity index between baseline and end of study |
Change in the psoriasis area and severity index between baseline and end of study |
|
Secondary Outcome
|
Outcome |
TimePoints |
Psoriasis disability index (PDI) at base line and end of study |
Time frame at 0 week, 6 week and 12 week |
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
28/10/2016 |
Date of Study Completion (India) |
19/06/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The
clinical study entitled “A randomized open labelled, Parallel group study to
evaluate the safety and efficacy of Cutisora Oil and Cutisora Tablet in fixed
dose as well as in Combination therapy in patients with Mild to Moderate
Psoriasis†is carried out in the skin care unit of R.G.G.P.G. Ayu. College & Hospital, Paprola, Distt.
Kangra (H.P.). This trial is sponsored by Vasu Research Centre, Vadodara. Two
drug Cutisora oil and Cutisora capsule are clinically tested in the patients of
mild to moderate psoriasis with PASI score less than 20.
Total three group were made and 25
patients were recruited in each group.
Group A - Cutisora oil group [Dose - topical Application twice a day]
Group B - Cutisora tablet group [Dose - 2 tablets twice
a day]
Group C - Cutisora Oil and Cutisora tablet group [Dose
- Topcial Application of oil and 2 tablets twice a day]
Mild
to moderate relief is observed in all the three groups which is statistically
significant. Some of the patients in all the three group show no any
improvement. The reason behind may be the dosage or the schedule of the
treatment as well as the other concomitant medication used by the patient
previously. Psoriasis disability index has also been observed before and after
trial but shows no any significant changes as we have recruited the patients
for the trial of only mild to moderate psoriasis. The patients of group C have
shown comparatively better results hence both drugs are recommended to be used
in combined form. Further
it is suggested that Cutisora capsule should be used 2 tablets twice a day
along with Cutisora oil locally twice a day for at least 6 months. So, that the
desired effect could be obtained. There
was no any adverse drug reaction reported during the study and follow-up period. |