| CTRI Number |
CTRI/2017/11/010570 [Registered on: 21/11/2017] Trial Registered Prospectively |
| Last Modified On: |
20/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of cutis capsule and cutis oil in Atopic Eczema |
|
Scientific Title of Study
|
A randomized open labelled , parallel group study to evaluate the safety and efficacy of cutis capsule and cutis oil in Atopic Eczema |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRajesh 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)
 Â
Â
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418102424 |
| Fax |
01894-242064 |
| Email |
drrajeshsood@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajesh 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)
 Â
Â
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418102424 |
| Fax |
01894-242064 |
| Email |
drrajeshsood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRajesh 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)
 Â
Â
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 390010Â
|
|
|
Primary Sponsor
|
| Name |
Vasu Research Centre |
| Address |
A Division of Vasu Healthcare Pvt. Ltd. 896/A, GIDC, Makarpura, Vadodra - 390010Â
Â
Â
|
| 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 |
| DrRajesh Sood |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital |
Skin Care Unit OPD Number
715
Kangra
HIMACHAL PRADESH |
09418102424
drrajeshsood@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, 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 atopic eczema with EASI score 15, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cutis capsule |
Cutis capsule-
ingredients- Mahamanjisthadi kwath,Panchnimba churn,Triphala churn,Acacia catechu,Tinospora cordifolia,Curcuma longa,Ganthak rasayan
Mode of administration-oral
Dose - 1 capsule thrice a day with water after meal
|
| Intervention |
Cutis oil |
Cutis oil-
Ingredients- Azadirachta indica oil,Pongamia pinnata oil,Brassica campestris,Psoralea corylifolia,Hydnocarpus laurifolia,Sesamum indicum,Mahatuvrak tail,Olea europoea
Mode of administration- external application over lesion
Dose- 3 times a day.Â
|
| Comparator Agent |
Cutis Oil and Cutis capsule combination |
Dose : External application of oil three times a day, 1 capsule thrice a day with water.Â
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Non pregnant,non lactating females
2. Patient with atopic eczema according to Rajka and Hanifin criteria
3. Patient with EASI score 15 at time of screening
|
|
| ExclusionCriteria |
| Details |
1. Pregnant,lactating mother
2. Patient with infected atopic eczema
3. Patient with severe systemic disorder
4. Patient with known hypersensitivity to excipients of drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the eczematic area and skin moisture level at end of study Â
|
0 day and 56th Day of the study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EASI score, SCORAD score,DLQI score at starting and at end of study |
at 14 days,28 days,after 56 days
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
27/11/2017 |
| 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="6"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 Cutis Oil and Cutis capsule in Atopic Eczema†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 drugs - Cutis oil and Cutis capsule will be clinically tested in the patients of atopic eczema with EASI score 15.
Total three group are made and 30 patients will be recruited in each group.
Group A - Cutis capsule group [Dose -1 capsule thrice a day after meal]
Group B - Cutis oil group [Dose - topical application thrice a day on affected area]
Group C - Cutis capsule and Cutis oil group [Dose - Topcial Application of oil and 1 tablet thrice a day]
|