| CTRI Number |
CTRI/2020/09/028010 [Registered on: 24/09/2020] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of application of Durvadya taila in Eczema. |
|
Scientific Title of Study
|
Comparative Phase-II Clinical Study To Evaluate Efficacy of Durvadya Taila
And Vishwamitra Kapal Taila In Vicharchika with Special Reference to Eczema |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Japa Jayant Phadke |
| Designation |
PG Scholar |
| Affiliation |
Ayurved seva sangh ayurved mahavidyalay Nashik |
| Address |
OPD NO 13 Kayachikitsa Department
Nashik
MAHARASHTRA
422003
India |
| Phone |
8600248131 |
| Fax |
|
| Email |
phadkejapa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Eknath Ganesh Kulkarni |
| Designation |
Professor and Guide |
| Affiliation |
Ayurved seva sangh ayurved mahavidyalay Nashik |
| Address |
OPD NO 13 Kayachikitsa Department
Nashik
MAHARASHTRA
422003
India |
| Phone |
9850071240 |
| Fax |
|
| Email |
ekulkarni6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Eknath Ganesh Kulkarni |
| Designation |
Professor and Guide |
| Affiliation |
Ayurved seva sangh ayurved mahavidyalay Nashik |
| Address |
OPD NO 13 Kayachikitsa Department
Nashik
MAHARASHTRA
422003
India |
| Phone |
9850071240 |
| Fax |
|
| Email |
ekulkarni6@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR Japa Jayant Phadke Ayurved Seva Sangh Ayurved mahavidyalay Ganeshwadi Panchvati Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Ayurved Mahavidyalaya Nashik |
| Address |
OPD NO 13 Kayachikitsa Department Arogyashala Rugnalaya Panchvati Nashik |
| Type of Sponsor |
Other [Government Aided Institute] |
|
|
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 Japa Jayant Phadke |
Arogyashala Rugnalaya |
OPD NO 13 Kayachikitsa Department Arogyashala Rugnalaya Panchvati Nashik
Nashik
MAHARASHTRA |
8600248131
phadkejapa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalay Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with Eczema |
| Patients |
(1) ICD-10 Condition: L20-L30||Dermatitis and eczema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Durvadya taila |
Topical application for 5 minutes two times a day for 60 days |
| Comparator Agent |
Viahwamitra kapal taila |
Topical application for 5 minutes two times a day for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of Vicharchika having signs and symptoms namely
Kandu(itching),Pidaka(Eruption),Vaivarnya(Depigmentation) and Srava (Discharge)
Patients of both Gender
Understanding and being willing to sign the informed consent form
|
|
| ExclusionCriteria |
| Details |
Patient having severe systemic diseases or condition along with Vicharchika
Pregnant & Lactating woman
Known case of Diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in itching
Reduction in eruption
Reduction in pigmentation
Reduction in discharge
|
60 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Eczema |
60 days
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
28/09/2020 |
| 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="6"
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)?
Response - NO
|
|
Brief Summary
|
The term Eczema is used to defined range of persistent and recurring skin rashes characterized by redness edema dryness and itching of skin with possible crusting ,cracking ,flaking,bleeding and oozing.Ayurveda attempts at curing vicharchika from its roots.In modern medicine external treatment for eczema is corticosteroids ,which gives symptomatic relief for a certain span of time.Durvadya taila is mentioned by acharya chakradatta for vicharchika.it contents Durva and Tila taila which has potency in curing skin diseases. |