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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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