| CTRI Number |
CTRI/2020/03/024030 [Registered on: 18/03/2020] Trial Registered Prospectively |
| Last Modified On: |
16/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Mango seed (Amra, Mangifera indica,seed) oil in dandruff |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Amrabeeja (Mangifera indica) taila in Darunaka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajatha M |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda And Hospital
BM Road Thanniruhalla Hassan-573201
India
BM Road Thanniruhalla Hassan-573201
Hassan
KARNATAKA
573201
India |
| Phone |
8095866185 |
| Fax |
|
| Email |
rajathasheregar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda And Hospital
BM Road Thanniruhalla Hassan-573201
Hassan
KARNATAKA
573201
India |
| Phone |
9448203499 |
| Fax |
|
| Email |
drpradeepa@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda And Hospital
BM Road Thanniruhalla Hassan-573201
Hassan
KARNATAKA
573201
India |
| Phone |
9448203499 |
| Fax |
|
| Email |
drpradeepa@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Shri Darmasthala manjunatheshwara college of Ayurveda and Hospital |
|
|
Primary Sponsor
|
| Name |
Rajatha M |
| Address |
BM ROAD, THANIRUHALLA, HASSAN |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Rajatha M |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
BM ROAD, THANIRUHALLA
Hassan
KARNATAKA |
8095866185
rajathasheregar@gmail.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 |
| Healthy Human Volunteers |
Dandruff |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mango seed oil |
Mango seed (Amra, Mangifera indica, seed) oil 200 ml, external application to scalp weekly twice for 30 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Itching at scalp
2.Diffuse hairfall
3.Roughness of scalp
4.Scaling of scalp
|
|
| ExclusionCriteria |
| Details |
1.Chronicity more than 3 to 5 years
2.Associated with any other dermatological conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Itching 0 -3 scale
Roughness 0-3 scale
Hairfall 0-3 scale
Scaling 0-3 scale
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/03/2020 |
| 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="2"
Months="4"
Days="30" |
|
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
|
[1]
This is an open label, single arm clinical study with Pre-test and Post-test
design wherein a minimum of 30 patients suffering from dandruff will be
selected irrespective of their gender, caste or creed conducted in a tertiary
Ayurvedic Hospital attached to Ayurvedic Medical College located in district
headquarters in southern India. The parameters of signs and symptoms will be
analyzed statistically.
Mango (Amra, Mangifera indica,seed) oil is given 200 ml for weekly twice
application for 30 days.The primary outcome measure
will be seen after 30 days of treatment
|
|